MAHARASHTRA UNIVERSITY OF HEALTH SCIENCE,NASHIK s

A synopsis for Phd.(Ayurveda) in the subject of

- Shalakya tantra

TITLE

“Randomized controlled clinical trial of Lodhradighrit tarpan

and Ushiraditel nasya in Presbyopia.”

NAME OF CANDIDATE - Dr. Vijay G. Bodkhe

P.H.D scholar 1st year

Department of Shalakya tantra

Year-2020-2021

NAME OF GUIDE - Dr. Virkar C. A.

Professor and HOD (shalakya tantra)

Department of shalakya tantra

NAME OF INSTITUTE - PDEA’S AYURVED COLLEGE AND RESEARCH CENTRE,NIGDI

1. TITLE “Randomized controlled clinical trial of Lodhradighrit tarpan and Ushiraditel nasya with
corrective eyeglasses in Presbyopia.”

2. INTRODUCTIO Ayurveda is an ancient science , Shalakya Tantra is the branch of an Ayurveda

N which deals with diagnosis and management of diseases occurring above the
clavicle. Viz. Diseases of eyes, ears, nose, throat, head and neck.
शालाक्यं नामोर्ध्वजत्रुगतानांरोगाणां शर् वणनयनवदनघ्राणादिसं श्रितानां व्याधीनामु पशमनार्थम्, शलाकायन्त्रप्रणिधानार्थ
सु .सू. १-१०

An eye is the most important sense organ of human body which resembles
the camera.
Presbyopia is a condition of physiological insufficiency of accommodation
leading to a progressive fall in near vision and it is not an error of
refraction. This a physiological phenomenon which affects all persons, and
usually evident at about the age of 35 to 45 years when the near point of
distinct vision. Decrease in the accommodative power of crystalline lens
with increasing age leading to presbyopia occurs due to
-Age related changes in the lens which include..
Decrease in the elasticity of lens capsule and progressive, increase in size
and hardness (sclerosis) of lens substance which is less early moulded.
-Age related decline in ciliary muscle power may also contribute in
causation of presbyopia.
Some causes of premature presbyopia are –
1) Uncorrected Hypermetropia
2) Premature sclerosis of the crystalline lens
3) General debility Causing pre-senile weakness of ciliary muscle,
4) Chronic. simple glaucoma

Symptoms are difficulty in near vision. patients usually complaint of

difficulty in reading small prints- to start with in the evening and in
dim light and later even is good light.
Another important complaint of the patients is difficulty in threading
a needle etc.
Asthenopic Symptoms due to fatigue of the ciliary muscle are also
 complaints after reading or doing any near work . Headache eye
feels tired .

अव्यक्तानिसरूपाणिसर्वाण्ये वप्रपश्यति । सु . उ. ७-६

दृष्टिर्भृशंविह्वलतिद्वितीयं पटलं गते ॥७॥ सु .उ.७

If this initial defect (prathampatalagat) becomes

secondary(dwitiypatalgat), the ambiguity increases. (Vival) visual illusions
give the appearance of flies, mosquitoes, hair, spider webs, circles, flags,
mirages, coils, fickle constellations or frog jumps (pariplava), as well as rain
streams, clouds and darkness. Corelation of DwithiypatalgatTimir is
condition can be associated with Presbyopia according to modern science.
In India,Prevalence of uncorrected Presbyopia. Is 33% but the confidence
limits for this estimate were very wide (95% CI: 19.1–51.0)
The prevalence of presbyopia has been estimated at nearly 80% by age
45–55 in North America 3,4 with an estimated 16% of these individuals
without adequate correction.
Tarpan is an ancient procedure for NetraRoga's . Sneha (Goghrut) is the
most beneficial among these four snehas that are: Ghrut, Majja, Vasa and
Tel.There are many references from granthas according to Ayurveda that
are: VaghBhat,Sharangdhar,Yogratnakar and Shushrutsamhita,
Bhavprakash. Following are the references used for the netratarpan and
nasya inTimir study:-

रोधमूर्वाप्रपु ण्ड्राह्रमांसीयष्ट्याह्नचन्दनै : सोशीरं साधितं सर्पिः सक्षीरं तपर्णहितम्।।अ.सं .उ.१६-५७,५८

उशीरलोधत्रिफलाप्रियङ्कुभिः पचे त्तुनस्यं कफरोगशान्तये ॥ सु .उ.१७-४१

उर्ध्वजत्रुविकारे षु विशे षान्नस्यमिष्यते ।

नासाहिशिरसोद्वारं तेनतद्व्याप्यहन्तितान्।।अ.ह.सू. २०/१

 “Nasahishirsodwaram”,that describes reference according to Ayurveda, that Nasya is
the beneficial therapy for urdhavajatrugatvyadhi.Therefore the topic selected for
research by me is the Role of Tarpan & Nasya in Timir patients.

Rationale of study- Presbyopia is caused as part of the natural ageing process of the eye. Close
objects appear blurred for the person with presbyopia .The ciliary muscles lose their ideal functioning
power over time and do not work effectively. Even the crystalline lens loses its flexibility over time (it

starts hardening), thereby affecting it focusing power.

The weaking of ciliary muscle can occur for following reasons eye fatigue because of constant load
on eye eg straining your eyes while working on computer for long time wathching tv, reading books
in dim light ,increased use of computer mobile phone screens,so hazardous effects are seen on
eyes. due to which symptoms of presbyopia increased like difficulty in near vision, asthopenia ,
headache etc . In lockdown because of work from home policy increased use of screens like
computer and mobile lead to increase in these symptoms and hence the disease has been very
common nowadays and it is more needed to find the effective treatment for presbyopia . Screening
time is more on small screen , woking near close objects like sewing , Harbour, dentists nowadays
starting near issues are 35 upto 40
As in modern science there is limited treatment available and it’s curity rate is not
satisfactory.and in Ayurveda simple treatments like of Lodhradighrit tarpan and Ushiraditel nasya
are available and many vaidyas are using these treatments.so to study the efficacy of netratarpan
and nasya it is planned to study the add on effect by using this formulation of Lodhradighrit tarpan
and Ushiraditel nasya with corrective eyeglasses.
3. PRIMARY Is corrective eyeglasses given with Lodhradighrit tarpan and Ushiraditel nasya for 7 days more
REARCH
effective than corrective eyeglasses alone for in presbyopia.
QUESTION

4. SECONDARY Not applicable.

RESEARCH
QUESTION
5. PRIMARY null hypothesis (H0) – Corrective eyeglasses given with Lodhradighrit tarpan and Ushiraditel nasya
HYPOTHESIS for 7 days is not more effective than corrective eyeglasses in Presbyopia.

Alternate hypothesis (H1) - Corrective eyeglasses given with Lodhradighrit tarpan and Ushiraditel
nasya for 7 days is more effective than corrective eyeglasses in Presbyopia.

6. SECONDARY Not applicable.

HYPOTHESIS
7. REVIEW OF Literature review about Lodhradighrit tarpan and Ushiraditel nasya is taken from Ayurved samhitas.
LITERATURE

Lodhradighrit tarpan and Ushiraditel nasya in Timir chikitsa from ashtang sangraha uttartantra
adhyay 16-57,58 and sushrut uttartantra adhyay 17-41
Extensive literary review will be done from standard modern text about disease-
AK Khurana- ophthalmology
L.C.Dutta-modern ophthalmology Tondon and sihota-Parsons disease of eye.
other related information of this topic will be reviewed from on ancient ayurved sanhitas,various
authentic research publications online and ofline & concerned modern science textbooks.

8. PREVIOUS
WORK DONE 1. Dishant Pandit-Assessment criteria for research on Dwitiya Patalgat Timir with reference to
 presbyopia: A critical view,Y.M.TAyurvedicMahavidyalyaKhargharNavi Mumbai. 2020
2. Mahesh Prasad Shah -A review on netra tarpana -an ayurveda method of eye care Institute
of Medicine, Ayurveda Campus, Kirtipur.2020
3. Hemalata Rajpurohit- An open label single arm clinical study on Vibhitakadi ghrita eye drop
and paana in the Management of prathampatalagatatimira (PRESBYOPIA) Shri Dharmasthala
Manjunatheshwara College of Ayurved and Hospital, Hassan, Karnataka, India.2019
4. Renu Rao-Effect ofthe Ushiradi Anjana on timira w.s.r to refractive errors and
presbyopia: a clinical study, Uttarakhandayurved University Dehradun (2017)
5. Lotika Bhrati- A clinical study on the effect of tarpana karma with phalatrikadi ghrita in
prathama patalagata timira with special reference to myopia, Rishikul Campus, Uttarakhand
Ayurveda University, Haridwar, Uttarakhand, India.2017
6. Gopinathan G. A Clinical study to evaluate the efficacy of Trataka yoga kriya and eye
exercise (non Pharmocological methods) in the management of timira.(Ammetropia and
Presbyopia) Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved
University, Jamnagar, Gujarat, India. 2016
7. .Bende Yogita. Pharmacodynamics Of Tarpana And Its Utility In Management Of
Myopia. Shri Ayurveda Mahavidyalaya, Nagpur.2016
8. Poonam- A clinical study on the role of Akshi Tarpana with Jeevantyadi Ghrita in Timira
(Myopia). Pankaj Kasturi Ayurveda Medical College, Trivendrum, Kerala, India.2011
9. Poonam R.M. A clinical study on the role of Akshi Tarpana with Jeevantyadi Ghrita in Timira
(Myopia) 2011
10. Dr. Dinesh Singh Gaur, A clinical study on the efficy of phalatrikadighrita on timir-
presbyopia Govt. Ayurveda College, Vadodara, India.2009,
11. Dr. Deshmukh R. D.Dwitiya patalgat timira (asth enopia) and its management through
triphaladi putapaka - a case study
12. Dr. AmrutSalunke. Role of panchakarmas in treatment of timir: mode of action and
contra-indications
13. Dr. Kiran B. Patil. Open, controlled, randomized study of systemic use of
ShatawariGhrita & ShatawariGhritaakshiTarpana in prathampatalgata timir WSR to simple
myopia
14.Dr. Sarala Dudhat. An evidenced based clinical study of vatajtimir with special reference to
primary Optic atrophy.
15 Mehetre Dhananjay, Role of tarpan kriyakalpa in the management of digital eye strain – a
case study.

Knowledge Gap:
No previous work was done on Lodhradighrit tarpan and Ushiraditel nasya in Presbyopia so topic is
selected.
 So it is planned to Randomized controlled clinical trial of Lodhradighrit tarpan and Ushiraditel
nasya with corrective eyeglasses given in Presbyopia.

9. PRIMARY To study the Randomized controlled clinical trial of Lodhradighrit tarpan and Ushiraditel nasya
OBJECTIVE for 7 days to corrective eyeglasses given in Presbyopia.

10. SECONDARY To observe adverse effects of the drug if any.

OBJECTIVE
11. MATERIAL AND
METHODOLOGY
study design type: Randomized controlled clinical trial(open labelled)
STUDY SETTING-
clinical study-
selection of patients-
selection of patients for Presbyopia will be done as per inclusion and assessment criteria from
ophthalmology OPD of our institute.
Grouping of patients-
GROUP A- Corrective eyeglasses given with Lodhradighrit tarpan and Ushiraditel nasya in
patients.
GROUP B- Corrective eyeglasses in patients.
Sample size:
Calculated by winpepi (version 11.38) software. Proportion effect of 0.5% carboxymethyl
cellulose eye drops is 0.83. assumed proportion effect of Lodhradighrit tarpan and Ushiraditel
nasya is 0.95. by considering patient dropout rate- 5%. At significance level 5% and power
80%.
Sample size is 30 in each group taken.
sampling technique: lottery method of simple randomized method is used.
selection criteria:
1.inclusion criteria-
patients from age group 35-60 years. Irrespective of gender,religion having sign and
symptoms of mild to moderate Presbyopia ( Difficulty in Near vision,Blurred vision,
Asthenopia, ocular fatigue,Headache,Eye strain,Photophobia ) in which atleast 3 symptoms
are present
2.Exclusion criteria-
known case of congenital anomalies of eyes.
Any acute infective condition of eyes.
Any tumor of eyes.
 Severe dry eye with corneal involvement
Steven’s Johnsons syndrome
3.Withdrawl criteria-
any serious adverse effect.
If Patient is not willing to continue treatment.
Any injury or infection occurs during study.
If Patient will be absent for followups.
statistical Analysis
location of study- OPD and IPD of shalakyatantra department of concerned institute.
Study population: patients of presbyopia fullfilling the inclusion criteria.
duration of study- 18 months
duration of treatment-
Corrective eyeglasses wearing daily
7 days for Lodhradighrit tarpan and Ushiraditel nasya.

After permission of IEC and BORS –

Case record form will be prepared.
Written informed consent from patients will be taken.

12 OPERATIONAL Not applicable

. DEFINITIONS
13 ASSESSMENT OBJECTIVE PARAMETERS- Criteria for assessment will be clinically done by clinical refraction,
. CRITERIA FOR retinoscopy, auto refractometer ,ophthalmoscopy & Snellen’s distant vision , Near vision test chart.
PRESBYOPIA
 SUBJECTIVE PARAMETERS17 -

Symptoms Absent mild moderate Severe

(1) (2) (3) (4)

Difficulty in Near No near Vision Mild Vision Loss Moderate Visual Severe visual
Vision Loss 20/30 to 20/60 impairment impairment
20/70 to 20/160 20/200 to Worse
Eye Strain No Eye strain Difficulty in keeping Blurred Vision, Diplopia,
eyes open,sensitivity diplopia, paining Difficulty
to light, dry or eyes, burning concentrating ,
wateryeyes ,vertigo eyes, itching eyes increased
sensitivity to
light.
Headache No Headache Mild head pain that Dizziness, Pain severe
is aching, squeezing numbness, behind the eye,
on both sides of the weakness around the eye
head, above the changes in associate with
level of the vision ,sensitivity nausea ,
eyebrows to light and vomiting , the
nausea eye might feel
sore or tired
Watering No watering Less watering eyes More watering Increased
eyes eyes eyes watering eyes

14. SPECIFICATIONS slit lamp,torch, auto refractometer ,ophthalmoscopy & Snellen’s distant vision , Near vision test
OF chart.
INSTRUMENTS
AND
RELATED
MEASUREMENTS
15. METHOD OF method of data collection relevant to objectives will be as per case record form given in this document
DATA below in annexure F.
COLLECTION
RELEVANT
TO
OBJECTIVES
16. DATA MS, Excel, SPSS, and primer of biostatistics etc. statistical software will be used as per requirement.
MANAGEME
NT
AND
ANALYSIS
PROCEDURE(
USE
OF
COMPUTER
AND
CODING)
17. PLAN FOR • For group A and B-
STATISTICAL
ANALYSIS Before and after treatment
Quantitative data Paired t test
Qualitative data Wilcoxon signed rank test

• For comparison between group A and B-

Quantitative data- Mann Whitney U test
Qualitative data- unpaired t test

18. ADDITIONAL
POINTS FOR
RESEARCH IN
AYUSH
18. ADDITIONAL DISEASES REVIEW- Will be done.
POINTS FOR TRIAL DRUG REVIEW
RESERCH IN Lodhradighrit tarpan (अ.सं .उ.१६-५७,५८)
AYUSH Drug Scientific Rasa Vipaka Virya Guna Karma Part used
Name
Lodhra
Murvel
Kamal
Jatamansi
Jyeshatam
adh
Chandan
Ushir

Mode of action-
By their individual properties the contents Lodhra, Murvel(Murudsheng), Kamalgatta,
Jatamansi, Jyeshatamadh, Chandan, Ushir and Ghrit in the Lodhradighrit tarpan like
Kaphapittanashak, Vatnashak, Shothhar and dahanasha will reduce symptoms of Presbyopia like
Difficulty in Near Vision, Eye Strain, Headache etc. in Ayurveda Timir roga symptoms are similar to
those of Presbyopia.and it is mainly produced due to vata and pitta dushti.so these all contents will
reduce the dushta pitta and vata with their madhur,tikta rasa shita virya,etc.
Also Ushir, Lodhra, Triphla (Amalaki, Haritaki, Vibhitak), Priyangu and Til Tel in the Ushiradi tel
Nasya Tridoshagna, shothahar, and dahnashak will reduce some symptom of presbyopia

• Raw drugs authentication will be done from authorized institute.

• Drug will be prepared from our institute’s attached pharmacy.
• Drug standardization will be done.

STANDARD CONTROL EYE GLASSES REVIEW-

Corrective eyeglasses in both eye

Eyeglasses are one of the simplest and most common ways of correcting presbyopia. Such eyeglasses
are also known as reading glasses and can be bought over-the-counter without a prescription from an
eye health professional. The refractive power of these glasses ranges from +1.00D to +3.00D more).
Even though reading glasses can be easily purchased without a prescription, it is advised to consult
with an eye health professional first to check if the refractive power required to correct the condition
needs to be updated or if these eyeglasses are suitable for your eyes.
.

PREPARATION AND ADMINISTRATION OF EYEGLASSES-

1. Reading glasses are available in the market so,it will be purchased from good
manufacturer authorized company.
2 LODHRADIGHRIT TARPAN -
S.O.P. for Lodhradighrit tarpan-
step 1 : Lodhra, Murvel, kamalgatta,jatamansi,jyeshatamadh, Chandan, ushir and For Ushiradi tel
nasya – Ushir, lodhra, amalaki, haritaki, bhibitak ,priyangu will be purchased from good
manufacturing practices (GMP) authorised source available in market.Authentication and
standardization of raw drug material will be done.
Step 2 : Lodhradighrit tarpan will be prepared as described below-
1) Lodhradighrit will be prepared by standard method as explained in
AshtangsangrhkarUttarsthan (Vaghbhat)
Kalka (1 part) + GoGhrit (4 part) + Kwath (16 part)
Boil on Low Flame (mandagni)
Boil till 1/4th of the total mixture remains
2) UshiradiNasya will be prepared by standard method as explained in Sushrututtarstahan
Kalka (1 part) + Tiltel (4 part) + Kwath (16 part)

Boil on Low Flame (mandagni)

Boil till 1/4th of the total mixture remains
Filling of Ghrit and tel-
Once the siddaghrit and siddatel are prepared, it will be filterd and filled in bottles to use as per
need
PROCEDURE OF TARPANA
Cleaning of the eyes
↓ preparation of concentric boundary along outer orbit with paste of mashachoorna
↓ Approximately 10 ml lukewarm Lodhradighrita will be filled in both eyes
↓ Allow to retain in eyes approximately for 20 mins.
↓ Patient will be allowed to close & open eyes frequently
↓ removal of Ghrit by making a hole in boundry& cleaning of eyes with lukewarm water

PROCEDURE OF Nasya
Putting 2 nasal drops into both nostrils according follow panchakarma snehan, swedan.
Results: -
Result will be drawn on the basis of criteria of assessment and statistical analysis Discussion: -
Discussion will be mentioned according to observations.
Conclusion: -
Conclusion will be drawn strictly based on statistical analysis.
Summery: -
The research study will be summarized in brief.

THERAPEUTIC MANNER OF TRIAL GROUP-

Eyeglasses and DRUG Corrective eyeglasses and Lodhradighrit netra tarpan and
Ushiradi tel nasya
ROUTE OF ADMINISTRATION Reading eyeglasses and netra tarpan, Nasya by procedure
DOSE Corrective eyeglasses in both eye wearing regularly and
Lodhradighrit netra tarpan and Ushiradi tel nasya one
time per day
DURATION OF TREATMENT 15 days for reading eyeglasses and 7 days of netra tarpan
and nasya
FOLLOW UP on 7th day and 15th day

THERAPEUTIC MANNER OF CONTROL GROUP-

Eyeglasses Reading eyeglasses

ROUTE OF Both on eyes
ADMINISTRATION
Wear eyeglass Corrective eyeglasses wearing daily
DURATION OF TREATMENT 15 days
FOLLOW UPS On 7th and 15th day
19. REFERENCES 1. Khurana A.K. Comprehensive ophthalmology:4th edition.New age international
publisher.
2. Datta L.C.modern opthalmology,volume-1:3rd edition.jaypee brothers medical
publisher.chapter 16.
3. Baghel M.edited by G.K.Jain,Reprint jamnagar,Research in ayurvedic publication:2005. 4.
Baghel M.and Jain G.K. Researches in Ayurveda:A researchable directory of titles of all India
Ayurvedic PG and Phd thesis.
5. Ayurvedic research database,6th edition.
6. shastri P., Sharangdhar Samhita.madhyamkhand:phanta kalpana.Chaukhamba publisher:
7th edition.page no.170
7. Kanski J.J.Clinical ophthalmology:7th edition.chapter5,page no.156
8. Deshpande,Ranade,Dravyagune vidnyan:Nandurkar publisher: 2011.
9. Mishra B., Bhavprakash nighantu,chaukhambha publisher page 786 madhu varga,and
page 161 karpuradi varga.
10.Shashri A. sushrut Samhitauttartantra:kriyakalpa adhyay.chaukhamba publisher:page no.97
11.Shastri A. sushrut sanhita –uttartantra, chaukhambha publisher,adhyay 6

12.trivedi-ashtang sangraha uttartantra,shri baidyanath ayu.bhavan publisher 20th adhyay page

313.
13. Mishra B. .Yogratnakar uttarkhand:Vidyatini hindi tika.chaukhama publisher:2012.page
no.384.
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tandulodak kalpana
15. shastri P., sharangdhar samhita uttarkhanda parishek.chaukhambha publisher. adhyay.13
page.379.
16. Bruix A. Adam A.Efficacy of carboxymethyl cellulose in the treatment of dry eye
syndrome.europepmc. https://europepmc.org/article/med/16511715
17. Bhargava R. Kumar P.evaluation of dry eye in patients with psoriasis.journal of ocular
biology.https://www.avensonline.org/fulltextarticles/JOCB-2334-2838-03-0018.html
18. Vd. AnantDamodarAthavle ,ShrimadVrudhaVaghbhatVirchitAshtangSangraha (U), Ch 16,
 54-55 Pune Shrimad AatreyPrakashan page no. 709
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choukhamba Sanskrit Sansthan page 32 and 62
20. KavirajDr.AmbikaDattShastri, Sushrut Samhita (P) Ch no 35 , 5-7 and SutrashtanCh 38, 14-
33-45 Varanasi choukhamba Sanskrit Sansthan page no 152 -153 and page no 144-145
21. Dr. Ganesh KrushnaGarde, SarthvaghbhatCh 13, 1-9 Pune, RaghuvanshiPrakashan Page no
388-389
22. Kaviraj Shri AmbikaDattShastri ,BhaishajyaRatnavaliCh 64, 90-97 Varanasi choukhamba
Sanskrit Sansthanpage no 665
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24. Dr. Narayan Vidhawansa, Shalakyatantra (Netrarog) Ch8 , 7-6, Amravati,
AnandPrakashan, Page no 23
Annexure A- objective criteria tests

Annexure B- information sheet

Annexure C- likhit rugna mahiti patrak

Annexure D- consent form

Annexure E- sammati patrak

Annexure F- case record form

And questionnaire related to it.

Annexure G- Gantt chart

Annexure A-

1. Schirmer test-
The Schirmer test is a useful assessment of aqueous tear production. The test involves
measuring the amount of wetting of a special (no. 41 Whatman) filter paper, 5 mm wide and
35 mm long. The test can be performed with or without topical anaesthesia. The test is
performed as follows:Excess tears are delicately dried.The filter paper is folded 5 mm from
one end and inserted at the junction of the middle and outer third of the lower lid, taking
care not to touch the cornea or lashes.The patient is asked to keep the eyes gently closed.
After 5 minutes the filter paper is removed and the amount of wetting from the fold
measured.Less than 10 mm of wetting after 5 minutes without anaesthesia is considered
abnormal.

2. TEAR FILM BREAK UP TIME (TBUT)-

The tear film BUT is abnormal in aqueous tear deficiency and meibomian gland disorders. It is
measured as follows:

Fluorescein 2% or an impregnated fluorescein strip moistened with non-preserved saline is

instilled into the lower fornix.The patient is asked to blink several times. The tear film is
examined at the slit lamp with a broad beam using the cobalt blue filter. After an interval,
black spots or lines appear in the fluorescein-stained film (Fig. 5.8A), indicating the formation
of dry areas.The BUT is the interval between the last blink and the appearance of the first
randomly distributed dry spot. A BUT of less than 10 seconds is suspicious.The development
of dry spots always in the same location may indicate a local corneal surface abnormality (e.g.
epithelial basement membrane disease) rather than an intrinsic instability of the tear film.

PATIENTS INFORMATION SHEET

Name of patient:
Date Of Birth:

Age : Sex:

Address-

Contact No-

• Who will conduct this trial?

This clinical trial is designed as a part of PHD. Research project by Vd.______________ ,under
the guidance of

Vd. ___________________________ .

• What is the subject of this trial?

“Randomized controlled clinical trial of Lodhradighrit tarpan and Ushiraditel nasya in Presbyopia.”

• What is the objective &Purpose of trial?

The main objective of this trial is to compare add on effects of Lodhradighrit netra tarpan and
Ushiradi tel nasya with to carboxymethyl cellulose 0.5% eye drops in dry eye syndrome.

• For how long will the patient participate in this trial?

The patient will be involved in this project for 15 days

• What is the number of patients in this trial?

60 patients will be taken for research studies

• What are the medicines used in this trial?

Lodhra, Murvel, kamalgatta,jatamansi,jyeshatamadh, Chandan, ushir, Ghrit is the main

ingredient in Lodhradi ghrit netra tarpan and

Ushir, lodhra, amalaki, haritaki, bhibitak ,priyangu and til tel is the main ingredient in Ushiradi
tel nasya. All are easily available in the market and safe.

• What is the research method of this trial?

The patient completing the specific criteria total 60 patients divided in 2 groups of 30 patients
each will be included in the project. In this research, the patient has to come to the hospital
regularly for 7 days for the procedure of netra tarpan and nasya. The eye examination of the
patient will be done as per follow up chart.

• How to take medicine?

Netra tarpan by procedure in both eyes for 20 minutes and 2 drops in each nostril

• When the patient should come back for follow up?

The patient should come back for follow up for every 7th and 15th day.

• How will the patient's information be used under this project?

The information of patients in the research study will be collected in the shalakya
department. It will also be used for research work only. The inspection report for research
studies will be kept confidential in the shalakya department.

• Does the patient receive some compensation for participating in the trial?

No compensation will be given for participation in the trial.

• Will the patient be charged for participation in the trial?

There will be no charge for the patient to participate in the trial.

• Who should I contact if there is any doubt about trial?

You can contact researcher and guide for any type of query at any time.

Researcher's contact no. Guide contact no.

• What rights does the patient have in the research project ?

The patient has the right to know all the information about the research trail. The
participation of patient in this trail is voluntary and the patient has the right to
withdraw from trail at any time and without any reason.
लिखित रुग्ण माहिती पत्रक

रुग्ण नाव

जन्म दिनांक

वय

पत्ता

सं पर्क क् र.

लिं ग

हा प्रकल्प कोण करत आहे ?

हा प्रकल्प पदव्यु त्तर अभ्यासाअं तर्गत

शोध प्रबं धक

शोध मार्गदर्शक
यां च्या मार्फ त केला जात आहे .

या प्रकल्पाचा विषय काय आहे ?

Presbyopia या व्याधीमध्ये लोध्रादि घृ त तर्पण व उशिरादि ते ल नस्याची व 0.5% carboxymethyl cellulose eye drops ची
उपयोगिते चा अभ्यास करणे

या सं शोधनाचा हे तु व फायदे काय आहे त?

बदलले ल्या जीवनशै लीमु ळे या व्याधीचे प्रमाण वाढले आहे . तसे च नै सर्गिक वय वाढल्यामु ळे व स्क् रीनचा वापर वाढल्यामु ळे या
व्याधीचे प्रमाण वाढले आहे . या अभ्यासप्रक्रिये मुळे लोध्रादि घृ त तर्पण व उशिरादि ते ल नस्याची या व्याधीतील उपयोगिता
कळणार आहे .

या प्रकल्पाचा सहभाग किती कालावधीसाठी असे ल?

या प्रकल्पाचा रुग्ण सहभाग १५ दिवसांसाठी असे ल.

या प्रकल्पात वापरली जाणारी औषधे कशापासून बनले ली आहे त?

या प्रकल्पात वापरले जाणारे लोध्रादि घृ त तर्पण व उशिरादि ते ल नस्यामध्ये लोध्र,

मु र्वे ल्,कमल,जटामांसी,ज्ये ष्ठमध,चं दन,उशीर,त्रिफला,प्रियं गु इत्यादी द्रव्य आहे त.

या प्रकल्पात रुग्ण सं ख्या किती असे ल?

कमीत कमी ६० रुग्ण सं शोधन अभ्यासासाठी घे तले जातील.

या प्रकल्पात सं शोधन पद्धत कशी आहे ?

या प्रकल्पात समाविष्ट करण्यासाठी रुग्णाची तपासणी करण्यात ये ईल. आवश्यक निकष पूर्ण करणार्या रुग्णास प्रकल्पात समाविष्ट
करण्यात ये ईल. या सं शोधनामध्ये रुग्णाची ने तर् तपासणी ही रुग्ण परीक्षा पत्रकानु सार केली जाईत. या प्रक्रिये अं तर्गत रुग्णास १,
७, १५ व्या दिवशी रुग्णालयात यावे लागे ल. या प्रक्रिये मध्ये एकू ण ६० रुग्णांचा समावे श करण्यात ये णार असून त्यांचे ३०-३० च्या
दोन गटात विभाजन करण्यात ये ईल.

औषध कसे घ्यावे ?

गट अ मधील रुग्णास carboxymethyl cellulose 0.5% eye drops १ थें ब ३ वे ळा डोळ्यांत घालावा लागे ल.

गट ब- मधील रुग्णास carboxymethyl cellulose 0.5% eye drops + लोध्रादि घृ त तर्पण व उशिरादि ते ल नस्य
दे ण्यात ये ईल.

रुग्णाने फेरतपासणी साठी कधी यावे ?

रुग्णाने फेरतपासणीसाठी ७व्या आणि १५व्या दिवशी यावे लागे ल.

सं शोधन प्रकल्पामध्ये सहभागी झाल्याबद्दल काही मोबदला मिळे ल का?

सं शोधन प्रकल्पामध्ये सहभागी झाल्यावद्दल रुग्णास मोबदला दिला जाणार नाही.

सं शोधन प्रकल्पामध्ये सहभागी होण्यासाठी रुग्णास काही शु ल्क आकारले जाईल का?

सं शोधन प्रकल्पामध्ये सहभागी होण्यासाठी रुग्णास कोणत्याही प्रकारचे शु ल्क आकारले जाणार नाही.

सशोधन प्रकल्पावद्दल काही शं का असल्यास कोणाला सं पर्क करावा?

सं शोधनातील कोणत्याही प्रकारच्या शं कांसाठी तु म्ही सं शोधकास व मार्गदर्शकास केव्हाही सं पर्क करु शकता.

सं शोधकाचा सं पर्क क् र.
मार्गदर्शकाचा सं पर्क क् र.

सं शोधन प्रकल्पात कोणते अधिकार आहे त?

रुग्णास सं शोधन प्रकल्पावद्दल सर्व माहिती जाणून घे ण्याचा अधिकार आहे . रुग्णाचा सं शोधन अभ्यासातील
सहभाग ऐच्छिक आहे व रुग्णाला सं शोधन अभ्यासातून कधीही व कोणते ही कारण न दे ता माघार घे ण्याचा अधिकार
आहे .

CONSENT FORM

Patient Code:

Title of Project-

“Randomized controlled clinical trial of Lodhradighrit tarpan and Ushiraditel nasya in Presbyopia.”

1. I, confirm that I have read and understood the information sheet dated for
the above study. I have had the opportunity to consider the information, ask
questions and have had these answered satisfactorily.

2. I understand that my participation is voluntary and that I am free to withdraw at

any time without giving any reason, without my medical care or legal rights being
affected.

3. I understand that individuals may look at relevant sections of my medical notes and
data collected during the study. I give permission for these individuals to have
access to my records both in respect of the current study and in respect of any
further research that may be conducted in relation to it, even if I withdraw from the
 trial. However, I understand that my Identity will not be revealed in any
information released to third parties or published.

4. I agree not to restrict the use of any data or results that arise from this study
provided such a use be only for scientific purpose(s).

5. I agree to take part in the above study.

Code Number of Patient

Date Signature/left Thumb Impression

Name of Person Taking consent

Date

Signature

Name of Witness

Date Signature

लिखितसम्मतिपत्र

रुग्णक् र.

रुग्ण नाम वय लिं ग

जन्मदिनांक

Randomized controlled clinical trial of Lodhradighrit tarpan and Ushiraditel nasya in

Presbyopia.
1. मी या पत्रकाद्वारे असे नमूद करतो/ करते की, मी दिनांक ……….. रोजी या प्रक्रिये सन्दर्भातील सर्व माहीती वाचली असून
त्याबद्दत उपस्थित झाले ल्या सर्व शं कांचे निरसन करण्यासाठी प्रश्न विचारण्याची सं धी मला मिळाली आहे . त्यामु ळे सर्व मु द्दे मला
शमले असून शका निरसन पूर्ण झाले आहे .

2. तसे च मी हे दे खील जाणून आहे की या प्रक्रिये मधला माझा सहभाग कोणत्याही क्षणी रद्द करु शकतो/शकते , त्याकरिता मला
कोणते ही कारण दे ण्याची गरज नाही व त्यामु ळे माझी कोणतीही वै द्यकीय से वा किंवा कायदे शीर न्यायविषयक अधिकार यांचे हनन
होणार नाही

3. मला अभ्यासक, अभ्यासासाठी काम करणारे इतर लोक व परिक्षक या लोकांना माझे सं बंधित नोंदी पाहाण्यासाठी माझी सं मती
घे ण्याची आवश्यकता नसे ल. मी प्रक्रिये मधु न माझा सहभाग काढून घे तल्यानं तर दे खील या प्रबं धासाठी किंवा इतर सं बंधित
अभ्यासासाठी माझ्याशी सं बंधित नोंदी माझ्या सं मतीशिवाय पडताळल्या जाउ शकतात याची मला जाणीव असून माझी याला पूर्ण
सं मती आहे .

4. तसे च मला कल्पना आहे की, माझी ओळख पूर्णत: गोपनीय राखली जाईल. या नोंदी कोणत्याही शास्त्रीय द्रुष्टीकोनातून
वापरण्यात मी अडवणूक करणार नाही. वरील सर्व गोष्टी मला समजल्या असून मी स्वे च्छे ने सं मती दे त आहे .

रुग्ण सही/ डाव्या हाताचा अं गठा

शोधप्रबं ध

साक्षां किताची सही व नाव

Department of SHALAKYA TANTRA (Post Graduate) (Affiliated to M.U.H.S. Nashik)

Case Paper Format

Title of Study-

Randomized controlled clinical trial of Lodhradighrit tarpan and Ushiraditel nasya in Presbyopia.

Phd. Scholar
Guide

Serial no.:

Date:

Name :

Address:

Age: Religion: Occupation: Gender:

PramukhVedana -

PurvvyadiVrutant -

Astavidhpariksha - Nadi- Mala- Mutra-

Jivha- Sparsh- Druka-

Netra Parikshan

Right Left

Pakshma Mandal(EYELASHES)-
Vartma Mandal (EYELIDS)- Urdhva:

Adhaha:

Shukla Mandal (CONJUNCTIVA)-

( SCLERA)-

Krushna Mandal- Karnika:(CORNEA)

Tarkamandal-(IRIS)

Drusti Mandal-(PUPIL)

Purva veshma(ANTERIOR CHAMBER)-

Drushtimani (LENS)-

Kaninika-

Apang-

Darshan Shakti Parikshan-

AbhingDrusti-(unaided)

SabhingDrusti-(aided)

Slit lamp examination –

Nidan- Chikitsa-

1) Sthanik –

2) Pathyapathya-

Nirikshan:-
Sr.No Symptom Da Da Da
. s y y y
1st 7th

Sr.no. Symptoms Day 1st Day 7th Day 15th

1. Difficulty for Near Vision

2. Eye Strain

3. Headache
4. Watery discharge

5. Any other symptoms

Adverse effect if any

Questionnaire

1. Have you worn contact lenses in the past? 1.Yes 2.No

2. Questions about EYE DISCOMFORT:

a) During a typical day in the past week, how often did your eyes feel discomfort?

0 Never 1 Rarely 2 Sometimes

3 Frequently 4 Constantly

b) When your eyes felt discomfort, how intense was this feeling of discomfort?

0 1 2 3 4 5

3. Questions about Difficulty in near vision

a) During a typical day in the past week, how often did your eyes feel dry? 0

Never 1 Rarely 2 Sometimes

 3 Frequently 4 Constantly

b) When your eyes felt dry, how intense was this feeling of dryness

0 1 2 3 4 5

3. Questions about EYE GRITTINESS AND SCRATCHINESS:

a) During a typical day in the past week, how often did your eyes feel gritty and

scratchy? 0 Never 1 Rarely 2 Sometimes

3 Frequently 4 Constantly

b) When your eyes felt grittiness and scratchiness, how intense was this feeling of
grittiness and scratchiness…

0 1 2 3 4 5

4. Questions about EYE BURNING AND STINGING:

a) During a typical day in the past week, how often did your eyes feel burning and

stinging? 0 Never 1 Rarely 2 Sometimes

3 Frequently 4 Constantly

b) When your eyes felt burning and stinging, how intense was this feeling burning and
stinging

0 1 2 3 4 5

5. Questions about TIRED EYES:

a) During a typical day in the past week, how often did your eyes feel tired? 0

Never 1 Rarely 2 Sometimes

 3 Frequently 4 Constantly

b) When your eyes felt tired, how intense was this feeling of tired eyes?

0 1 2 3 4 5

6. Question about EYELID REDNESS:

During a typical day in the past week, how often did your eyelid margins look red?

0 Never 1 Rarely 2 Sometimes

3 Frequently 4 Constantly

7. Question about ARTIFICIAL TEAR USE:

During a typical day in the past week, how often did you use artificial tears?

0 Never 1 Rarely 2 Sometimes

3 Frequently 4 Constantly

8. During a typical day in the past week, how often did you use a computer/phone/any
other screen?

0. Never 1. 1 to 2 hours 2. 3 to 6 hours

3. More than 6 hours

9. Are you currently taking any of the following medications? Yes / No If yes specify.

10. How much time you have been using mask in covid period?

0. Never 1. 1 to 2 hours 2. 3 to 6 hours

3. 7 to 12 hours 4. More than 12 hours

11. How much do you have screen time?

0.less than 1 hour 1. 1-3 hours 2. 3-8 hours

3.more than 8 hours

TIMELINE/ GANTT CHART:

NAME:

DEPARTMENT:

DATE OF APPROVAL:
 GANTT CHART
Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
Activity

Review of literature Y Y Y Y
Procurement of drug Y Y
Authentication of drug Y Y
Formulation Y Y
preparation
Standardization of drug Y Y

Packing NA
Clinical trial CTRI Y Y Y Y
registration
Pre-preparation of Y Y Y
clinical trial
Enrolment of patients/ Y Y Y Y Y Y Y Y
subjects with clinical
trial reporting
Data entry in master Y Y Y Y
chart
Statistical analysis Y Y
Dissertation writing Y Y Y Y Y Y
Dissertation binding Y Y
Signing of concerned Y Y
authority

GUIDE NAME- GUIDE SIGNATURE-