SYNOPSIS

CLINICAL STUDY TO EVALUATE THE EFFICACY OF BRAHMI AVLEHA ALONG WITH BRAHMI
TAILA PRATIMARSH NASYA IN THE MANAGEMENT OF ATTENTION – DEFICIT /
HYPERACTIVITY DISORDER IN CHILDREN

SUPEVISOR CO-SUPERVISOR
DR. HARISH KUMAR SINGHAL PROF. PREM PRAKASH VYAS
M.D. (AYU.) M.D. PH.D. (AYU.)

SUBMITTED BY
DR. RANI KHANDELWAL
M.D. SCHOLAR
(BATCH 2021)
Research question

 Whether the Brahmi Avleha along with Brahmi Taila Pratimarsh nasya will be effective in the management of
attention – deficit / hyperactivity disorder in children?

 HYPOTHESIS
 Null Hypothesis (Ho): Brahmi Avleha along with Brahmi Taila Pratimarsh Nasya will be not effective in
management of ADHD in children.
 Alternate Hypothesis (H1): Brahmi Avleha along with Brahmi Taila Pratimarsh Nasya will be effective in
management of ADHD in children.
Introduction
 ADHD is one of the most common neurodevelopmental disorders of childhood. It is usually first
diagnosed in childhood and often lasts into adulthood. Children with ADHD may have trouble
paying attention, controlling impulsive behaviors (may act without thinking about what the result
will be), or be overly active.ADHD manifests in childhood with symptoms of hyperactivity,
impulsivity and/or inattention.
 ADHD is a cognitive disorder that afflicts approximately 2-7% of children globally. ADHD
prevalence in India, however, is much higher than the global average. Community or school-based,
cross-sectional or cohort, reporting the prevalence of ADHD in children aged ≤ 18 y in India, the
prevalence in children to be higher than the global estimate, at 11.32%.
 According to Ayurveda, correlation of ADHD can be done with vat pittaj unmada about abnormal
behaviour like Anavasthita, Chittatva, Mano vibhrama, Buddhi vibhrama, Smriti vibhrama, Sheela
vibhrama, Cheshta vibrama and Achara vibhrama.
 Some other references in Ayurveda classics states that vitiation of dhee (rational thinking), dhriti
(retaining power of the mind), smriti (memory) which causes abnormality and abnormal conduct
resulting into emotional outburst, excessive excitement anger, preponderance to violence, improper
contact of the senses with their objectives and give rise to inattention, hyperactivity and impulsivity.
Review of literature
 Literary references will be collected & discussed from Ayurveda classics, commentaries, modern literature.
 Websites such as PubMed, Google Scholar, Ayush research portal and Internet etc. These will be analysed to
explain literary aspect of Attention Deficit Hyperactivity Disorder (ADHD).

 OBJECTIVE

 Primary Objective
 To evaluate the efficacy of Brahmi Avleha and along with Brahmi Taila Nasya in the management of Attention –
Deficit / Hyperactivity Disorder in children

 Secondary Objective
 To ameliorate the symptoms of ADHD in children
 To develop diet chart for ADHD suffering children
 To improve school performance and health status of children.
 To collect literature of ADHD from Ayurveda and Modern aspects.
Methodology

 Study design- Single arm open labelled

 Study setting- Selection of the patients for the present study will be done from OPD and IPD
of Department of Kaumarbhritya, attached hospital of Dr. S. R. Rajasthan Ayurveda
University, Jodhpur and primary schools located in Jodhpur region and surrounding area.
Detailed will be recorded in especially designed clinical record format. Study will be
completed on 76 patient.
 Sample Size-76 Children
 Intervention Groups- Single group
 Purpose - Treatment
 Duration of study- 45 days
 Follow up- 15th day during trial period and 90 days after completion of trial
 Criteria for selection-
(A) Inclusion criteria:
 Individual between age group of 6 to 15 years of both sexes
 Individual satisfying DSM -V criteria.
 Individual having borderline or more IQ will be considered
(B) Exclusion criteria
 Individual below 6 year & above 15 years of age.
 Mental disorders like conduct disorder, anxiety, depressive disorders, obsessive compulsive
disorder.
 Children with schizophrenia.
 Children having medical illness like hearing loss, hypothyroidism, genetic disorder &
seizures disorder.
 Children having congenital deformity or Muscular dystrophy.
 Children suffering from any severe or acute infections.
 (C) CRITERIA FOR DIAGNOSIS:

 ADHD affected children will be screened by pre assessment criteria based on Vanderbilt
Assessment scale & diagnosed on the basis of DSM V (Diagnostic & Statistical Manual for
Mental Disorders).

 (D) ASSESSMENT CRITERIA:

 SUBJECTIVE CRITERIA
 DSM V (Diagnostic & Statistical Manual for Mental Disorders)

 OBJECTIVE CRITERIA
 IQ Assessment by Draw A Man Test
 Attention Span by Coefficient of Division
 Reaction time by Vernier Chronoscope

TRIAL DRUG
 For the present study, Trail drug Brahmi Avleha (Oral use) and along with Brahmi Taila
(Nasya) are selected which are described in Kashyap Samhita, 18th chapter, Lehadhyay &
Rastantrasaar evam Sidhhaprayog Sangraha , under the 18th chapter of Unmada
respectively.
Brahmi Avleha:-

ब्राह्मी माण्डू कपर्णी च त्रिफला चित्रको वचा I

शतपुष्पाशतावर्यो दन्ती नागबला त्रिवृत् I
एकै कं मधुसर्पिभ्यां मेधाजननमभ्यसेत् II ( का. सू लेहध्याय २९-३०)
 Table No.1 Showing ingredients of
Brahmi Avleha:-
S. No Ingredients Latin name Part used Quantity
1 Brahmi Bacopa monnieri (L.) Wettst. Whole plant 1 Part
2 Mandukparni Centella asiatica Linn. Whole plant 1 Part
3 Haritaki Terminalia chebula Retz. Fruit 1 Part
4 Vibhitak Terminalia belerica Fruit 1 Part
5 Aamlaki Emblica officinalis Fruit 1 Part
6 Chitrak Plumbago zylenica Linn. Root 1 Part
7 Vacha Acorus calamus Linn. Bhumi kanda 1 Part
8 Saunf Foeniculum vulgare Seeds 1 Part
9 Shatavari Asparagus racemosus Root 1 Part
10 Danti Baliospermum montanum (Willd.) Root 1 Part
11 Nagbala* Sida veronicoefolia Root 1 Part
12 Nishoth Operculina terpenthum R. Br. Root 1 Part

*Nagbala is rare drug, in absence of Nagbala , Danti will be taken as a substitute drug. Danti will be taken 2 part.
Table No. 2 Showing Ingredients of Brahmi Taila
Kalka dravya-
 Vacha, Kooth, Dashmool, Erandmool, Nagkeshar, Tejpatra, Chareela, Panri, Jatamansi,
Shweta Chandan, Daruhaldi, Shankhpushpi, Brahmi, Bala and Giloy. Total 24 Kalka
Dravya are crushed with Brahmi Kwath and prepare in Goat milk.
 Ingredients:-
S.No. Drug Name Latin Name Part used Quantity
1) Brahmi Bacopa monnieri (L.) Whole plant 1 Part
Wettst.

1) Bhringraj Eclipta protrata Leaves 1 Part

1) Shankhpushpi Convulvulous pleuricaulis Flowers 1part

1) Krishna Tila Sesamum indicum L. Seeds 1part

1) Goat Milk 1 Part

Grouping and Posology:-
76 children will be randomly selected as given below:-
Number of Children 76
Name of Drug Brahmi Avleha along with Brahmi Taila Nasya
Dose  Brahmi Avleha (Oral use)- Dose according to the Young’s
Formula
 Brahmi Taila (Nasya) – Pratimarsh Nasya i.e. 2 drops
Vehicle ( Anupana) Ghrita and Madhu
Randomisation Simple Random sampling
Duration of Study 45 days
Dose:-
The dose of drug administration is calculated based on Young’s Formula.
 Pratimarsh Nasya (Daily Oil Nasya):- This type of therapy is administered by dipping the
clean little finger in Brahmi Taila and inserting into each nostril. After inserting the clean
finger (dipped in Brahmi Taila ) into the nostril, the nasal passage is lubricated and given a
gentle massage. By doing this, the deep nasal tissues are opened up.

 FOLLOW UP STUDY
 Follow up will be done after every fortnightly during the study
 90 days after completion of the study.

 WITHDRAWAL CRITERIA
 During the course of clinical trial, if a children develops any serious condition, which
requires urgent treatment.
 If child's parents want to withdraw his child from the clinical trial
PARAMETER FOR ASSESSMENT OF STUDY OUTCOMES:
 PRIMARY ENDPOINT:-
 Brahmi Avleha along with Brahmi Taila Pratimarsh Nasya will be effective to ameliorate
symptoms of Attention – Deficit / Hyperactivity Disorder in children.
 SECONDARY ENDPOINT:-
 Brahmi Avleha along with Brahmi Taila Pratimarsh Nasya will be helpful to reduce sign
and symptoms of ADHD.
 Brahmi Avleha along with Brahmi Taila Pratimarsh Nasya will be helpful to reduce drop
outs from schools.
 Brahmi Avleha along with Brahmi Taila Pratimarsh Nasya will be provide a safe and
effective treatment.
 Brahmi Avleha along with Brahmi Taila Pratimarsh Nasya will be helpful to reduce
comorbidities.
 OBSERVATION AND RESULT
 Changes in the sign and symptoms will be recorded.
 The full details and history of patient will be recorded as per the case history performa
specially designed for present study work. Assessment will be done pre, during and post
treatment.
 STATISTICAL METHODS FOR ANALYSIS
 Objective parameter of individual group will be assessed with the help of paired t Test or Z
test, While subjective parameters will be assessed with the help of wilcoxon signed rank test,
Wilcoxon sum rank test for statistical analysis.
Thank you……………….