GUIDELINES FOR THE PREPARATION OF A DISSERTATION FOR

UNDERGRADUATE AND POSTGRADUATE DEGREE

1. Paper and Printing

Each copy shall be on clear white paper of good quality having at least 80 GSM and A4 size
(210 x 297mm). One type of paper must be used throughout the project report. However, papers
of different quality and size may be used for figures, maps, etc. Each copy shall be computer
printed. One font (preferably Times New Roman - size 12) must be used throughout the project
report. The use of bold type headings and italics for emphasis is permitted. All typing should
be on one side of the paper only, 1.5 spaced, with the left hand margin not less than 40 mm,
right hand margin not less than 15 mm and top and bottom margins not less than 25 mm.
Photocopies should be clearly legible.

2. Illustrations

Drawings, diagrams, maps etc. should be clear and may be reproduced by photographic or other
processes. They should carry captions on the same page.

3. Number of words

The total number of words in a project report

Undergraduate – 10000 words
Postgraduate Diploma – 15000 words
MSc 15000 – 20000 words

4. General Format

In the first instance the temporarily bound project report (two copies) should be submitted for
evaluation. Four or more copies of final corrected version of the project report should be
submitted in properly bound form. The general format of the project report shall be as follows:

(i) The Title

The title shall be the title approved by the relevant Board of Study. It should be informative
and descriptive of the work done. As shown in the Section 9.3, year of effective date of award
of degree should appear at the bottom of the title page.
(ii) Declaration

Each project report should carry a declaration as specified in Section 9.6.

(iii) Abstract

This shall consist of the title of the project report, name and address of the author and a
summary not exceeding 350 words as given in Section 9.5.
(iv) Acknowledgments

The candidate shall declare in the report the extent to which assistance has been obtained from
others in the collection of material, design and construction of apparatus, performance of
experiments, preparation of the report, financial support etc.
(v) Table of Contents

(vi) List of Tables

(vii) List of Figures

(viii) List of Abbreviations

(ix) Main Body of the Text

This shall include introduction, survey of prior research, objectives of the study, research
design, results, analysis, discussion and conclusions. References should be cited in the text
either by author and year or numbered. Standard International units should be used. Unit
symbols should be written after the numerical value, leaving a space between, e.g., 5 m.

(x) List of References

The references in the text should be listed at the end of the report. The references should be in
the author-year system. The format to be used is given in Section 12.15.9.

(xi) Appendices

Any detailed description, recipe or set of data could be included under an Appendix.

5. Numbering of Pages

Each page in a report should be numbered in consecutive order. This includes illustrative
material as well as text. For the prefatory pages (title page to list of abbreviations) small Roman
numerals should be used and placed 10 mm below the midpoint of the top edge of the page.
All pages of the main body of the report, beginning with the introduction or Chapter 1 up to
the last page of the report should be numbered with arabic numerals.

The first page of each major section (e.g. the first page of chapter) should be numbered 10 mm
above the midpoint of the bottom edge of the page. All other pages must be numbered in the
upper right hand corner of the page 10 mm from the top and right edges.

6. Tables and Figures

Tables and Figures should be numbered with Arabic numerals according to chapter number
with decimals. e.g. the third figure in Chapter 1 should be numbered as Fig. 1.3 or Table 1.3.
Title of a table should be clear and meaningful, and should be placed at the top of the table.
Only relevant data should be presented in any tables included in the project report. If there are
masses of data which take up three to four pages or more, they should be placed in an Appendix
and not in the main body of the text. The figure caption should be at the bottom of maps, line
drawings, photographs and graphs. Every map should bear: the coordinates, a linear scale, the
2
directive arrow, and index map showing locality of area dealt with. Line drawings should
contain only essential information and should illustrate some points in the text. Graphs may be
line graphs or bar graphs and the choice of which is to be used at any time depends on the data
to be presented. Only good-quality photographs should be included and only if they are useful
in illustrating something in the text. All maps should include a scale. The table titles and figure
captions should be of the same font-style as in text but of smaller size (preferably Times New
Roman and size 10) and single spaced if there are more than one line.

Table 1.3. Serum lipid levels of hyperlipidaemic patients before the treatment

Group Total Triglyceride HDL LDL Cholesterol

Cholesterol Cholesterol
Group A
Group B

300
Serum concentration of lipid (mg/dl)

250

200

150 Group A
Group B
100

50

0
Total Cho Triglyceride HDL Cho LDL Cho VLDL Cho

Figure 1.3. Serum lipid levels of hyperlipidaemic patients before the treatment

7. Specified Colours and Binding

Each copy of the project report should be bound with rexin or material of equivalent quality.
The cover should be in the colour specified for the particular degree with gold lettering as given
below:
Undergraduate Black
Postgraduate Diploma: White
Master of Science: Red

As shown in Section 8.1, the cover should carry the full title of the project report, name of
candidate, degree sought and year of effective date of award of degree. The spine (see Section
8.2) shall also carry the title, name of candidate, degree sought and year of effective date of
award of degree. If the approved title is too long, the approved short title should be printed on
the spine.
3
8. References/Bibliography Format

In the dissertation, references may take following form:

Author-Year System

The Author-Year System is preferred by scientists and editors, particularly in medicine and
biosciences. In this system, reference numbers are totally avoided. Instead the name of the first
author of the publication (or the names of the first and second authors if there are only two)
appears together with the publication year of the document.

References should be arranged first alphabetically under author/s name/s and then in
chronological order if several papers by the same author/s are cited. Use a,b,c etc. after the year
to distinguish papers published by the same author/s in the same year.

The text: The surnames/s of author/s should be followed by the year, to which may be added
a,b, c etc. to distinguish papers published by the same author/s in the same year.

(I) Two authors: use both names and the year. Do not use et al.

(II) Three authors: on first citation use all authors’ names and the year. Thereafter
it is usually sufficient to give the name of the first author followed by et al. and
the year.

(III) More than three authors: on first citation and thereafter give the name of the first
author followed by et al. and the year.

The following examples illustrate how Author-year citations can be incorporated into a running
text.

Young (1981) and also Peterson (1983) report …... Recent studies (Silva and Perera,
1996) have shown… that the actual value is higher (Senaratne et al., 1995).

Recommended Format forAuthor-Year System

Journal article:

1. Bell, C.H. (1991). Diapause and cold tolerance of larvae of Ephestia elutella.
Postharvest Biology and Technology 1, 81-93.

2. Priesler, H.K. and Robertson, J.L. (1992). Estimation of treatment efficacy when the
number of test subjects is unknown. Journal of Economic Entomology 85,1033-1040.

3. Waite, D.T., Grover, R., Westcott, N.D., Sommerstd, H. and Kerr, L. (1992). Pesticides
in ground water, surface water and spring runoff in a small Saskatchewan watershed.
Environmental Toxicology and Chemistry 11, 741-748.

4
Journal article (electronic):

Williams, F. (1997). Electronic Document Delivery – a trial in an academic library.

Ariadne issue 10, July 15. http://www.ariadne.ac.uk/issue10/edd/ (December 5 1997)

Journal without volume numbers:

Jang, E.B. (1991). Thermal death kinetics and heat tolerance in early and late third
instars of the oriental fruit fly (Diptera: Tephritidae). Journal of Economic Entomology,
1298-1303.

Journal with new pagination in each issue:

Becker, L.J. and Seligman, C. (1981). Welcome to the energy crisis. J. Social Issue 37
(2), 1-7.

Translation journal:

Assink, E.M.H. and Verloop, N. (1977). Het aanleren van dee-geheel relaties in het
aanvankelijk rekenonderwijs [Teaching part-whole relations in elementary
mathematics instruction]. Pedagogischi Studien 54,130-142.

Reference to abstract of an article:

Karunaratne, W.M.A.A. and Dissanayake, C.B., 1983.The distribution of goldmines

and mining villages in ancient Sri Lanka. Abs. First Geology Symposium of Sri Lanka:
University of Peradeniya.

Paper not yet published:

Potting, R.P.J., Otten, H. and Vet, L.E.M. (1997). The relation between parasitoid
ecology and learning: absence of learning in the stemborer parasitoid Cotesia lavipes.
Animal Behaviour (in press).

Monograph:

Gunatilleke, C.V.S. (1996). A nature guide to the world’s end trail, Horton
Plains.Peradeniya Science Publication 5.

Chapter in monograph:
Ugi, I. (1971). Isonitrile chemistry, New York, Academic press; Chapter 2.

Book:
Abeles, F.B. (1973). Ethylene in Plant Biology. Academic Press, New York.

Edited Book:

5
 Worthing, C.R. and Walker, S.B. (1987). The Pesticide Manual, 8th edn. British
CropProtection Council, Thornton Heath.

Chapter in edited book:

Ries, S.K. (1976). Subtoxic effects on plants. In Herbicides: Physiology,Biochemistry,

Ecology, 2nd edn. Vol. 2, ed. L.J. Audus. Academic Press Inc. (London) Ltd, Chapter
2, 313-344.

Edited symposia, special issues, etc., published in a periodical:

Kimball, B.A. and Idso, S.B.(1983). Increasing atmospheric Carbon Dioxide: effects
on crop yield, water use and climate. In: J.F. Stone and W.O. Willis (Editors), Symp.
Plant Production and Management under Drought Conditions, 4-16 October 1982,
Tulsa, OK. Agric. Water Manage. 7, 55-72.

Patent:
Kysika, J.O., Sawiciki, C.A., Apparatus and method for measuring optically active
materials, U.S. Patent 352 321, 1983.

Report:
Cregg, B.M. (1990). Net Photosynreport and carbon allocation of loblolly pine
(Pinustaeda L.) branches in relation to three levels of shade. Ph.D. report, University of
Georgia, USA.

Report (website):

Smith, J. (2000) Curly’s Airships Polegate, Masters of Arts Available from:

http://www.curlysairships.com (Accessed 29 May 2001).

9. Specimen Pages

Boxes given in the specimen pages represent A4-size pages or spine of the project report, but
not to scale. The font to be used is specified at the right hand side margin of the pages

6
9.1 Specimen Cover Page
This box should not appear on the cover page

PREPARATION AND CHARACTERIZATION OF

FERRITE NANOPARTICLES
(Times New Roman, size 14)

POSTGRADUATE DIPLOMA IN KAYCIKITSA

(Times New Roman, size 12)

SAMPATH KUMARA RANASINGHE

(Times New Roman, size 12)

(FGS/GWAI/2017/PGDK/0000)
(Times New Roman, size 12)

2020
(Year of Submission)
(Times New Roman, size 12)

2017
(Year of Submission - Times
7 New Roman, size 14)
 This box should not appear

(Times New Roman, size 14)

2020
S. K. RANASINGHE DEVELOPMENT OF A HEALTH MANAGEMENT SYSTEM FOR SCHOOLS Pg.Dip in Kayacikitsa

8
(Times New Roman, size 12)
9.2 Specimen Spine
9.3 Specimen Title Page This box should not appear

DEVELOPMENT OF A HEALTH MANAGEMENT

SYSTEM FOR SCHOOLS
(Times New Roman, size 14)

A dissertation submitted to the Board of Study for Postgraduate Degree as a fulfillment of the
requirement for the award of
(Times New Roman, size 12)

POSTGRADUATE DIPLOMA IN KAYACIKITSA

(Times New Roman, size 12)

PRESENTED BY
(Times New Roman, size 12)

B. C. PERERA
(Times New Roman, size 12)
(FGS/GWAI/2017/PGDK/0000)
(Times New Roman, size 12)

SUPERVISED BY

DR. A. B. C. PERERA (BAMS, MD Ayur, PhD)

(Times New Roman, size 12)

GAMPAHA WICKRAMARACHCHI AYURVEDA INSTITUTE

UNIVERSITY OF KELANIYA
YAKKALA SRI LANKA
(Times New Roman, size 12)

8.4 Specimen Declaration Page

DECLARATION 2020
(Year of Submission)
(Times(Times
NewNewRoman,
Roman,size 14)
size 12)

9
 GAMPAHA WICKRAMARACHCHI AYURVEDA INSTITUTE
UNIVERSITY OF KELANIYA
YAKKALA, SRI LANKA

CERTIFICATE

I certify that this is an independent dissertation on the title "A Clinical Study on the Efficacy
of New Herbal Formulation in the Management of Hyperlipidaemia" done by Mr. A. B. C.
Kkkkkkkkkkkkkkkk (FGS/GWAI/PGDK/2017/0000), under my supervision and guidance, is
in accordance with the rules and regulations of the prescribed course and also the subject matter
and the ideas are adequate.

................................... ..........................................
Signature Date

Dr. W. ………………………… (DSAMS (Hons), MD (Ayur), PhD)

Senior Lecturer in Kayacikitsa,
Department of Cikitsa
Gampaha Wickramarachchi Ayurveda Institute,
University of Kelaniya,
Yakkala, Sri Lanka.

10
 GAMPAHA WICKRAMARACHCHI AYURVEDA INSTITUTE
UNIVERSITY OF KELANIYA
YAKKALA, SRI LANKA

DECLARATION

I hereby declared that this submission is my own work and to the best of my knowledge, it
contains no material previously published or written by another person, no material wish to
substantial extend has been submitted or accepted for award any other degree or diploma of a
university or any other institute of higher learning, except where the acknowledgement is made
in the text.

..................................................... .........................................
B. C. WABCSJADH Date
(FGS/GWAI/PGDK/2017/0000)

11
9.5 Specimen Abstract (1 – 2 pages)

POLYPYRROLE BASED CONDUCTING POLYMERS

AND THEIR ELECTROCHEMOMECHANICAL
PROPERTIES
(Times New Roman, size 14)

K. P. Vjkhdkjhkjhlkjasd
(Times New Roman, size 12)

Graduate Studies Division

Gampaha Wickramarachchi Ayurveda Institute
University of Kelaniya
Yakkala, Sri Lanka
(Times New Roman, size 12)

ABSTRACT

The influence of preparation conditions on the properties of electroactive poly-Nmethylpyrrole

PNMP) films were investigated by varying preparation conditions with a view of obtaining
highly conductive films. Characterizations were done using cyclic voltammetry and impedance
spectroscopy. Conductivity of PNMP films was very much affected by the polymerization
current density, pH and the polymerization temperature. Electrochemical Quartz Crystal
Microbalance (EQCM) studies revealed that anions are the moving species during the redox
process in PNMP films that were prepared and cycled in aqueous electrolytes containing small
anions.

Polypyrrole (PPy) films were prepared with large surfactant anion, dodecy1 benzenesulfonate
(DBS-), and their properties were compared with those of PPy films prepared with small
anions. EQCM studies on PPy/DBS films showed a dual step scheme for the redox process in
aqueous electrolytes. Lithium rechargeable cells were fabricated using PPy/DBS as the
cathode. Continuous charge-discharge experiments showed that these cells could be cycled
more than 1000 times without any appreciable charge decay.

Key Wards: Polypyrrole, Polymers,

(Times New Roman, size 12)

12
ACKNOWLADGEMENT

13
 TABLE OF CONTENTS

Page No

Declaration i

Certificate ii

Abstract iii

Acknowledgement iv

Table of Contents v

List of Tables vi

List of Figures vii

CHAPTER I - INTRODUCTION

1.1 Background of the research 1

1.2 Significance of the study 3

1.3 Scope of the research 4

1.4 Aim and objectives 5

1.4.1 General objective

1.4.2 Specific objective

1.5 Hypothesis

CHAPTER II – LITERATURE REVIEW

CHAPTER III– MATERIALS AND METHODS

3.1 Setting of the research

3.2 Selection of patients

3.3.1 Inclusion criteria

3.3.2 Exclusion criteria

3.3. Sampling technique/ Method of Randomization

14
3.4 Criteria for the assessment

3.5 Preparation of Herbal Formula

3.5.1 Reference

3.5.2 Authentication

3.5.3 Ingredients and Method of drug preparation

3.5.4 Dosage and Administration

3.5.6 Dietary management

3.6 Follow up

3.8 Data Processing and Analysis

CHAPTER IV - RESULTS

4.1 Observation

CHAPTER V – DISCUSSION AND CONCLUTION

5.1 Discussion

5.2 Conclusion

5.3 Recommendations

15
 LIST OF TABLES

Table 1 Percentage distribution of patients according to the age 45

Table 2 Percentage distribution of gender 48

Table 3 Lipid profile of patients of group A and group B 55

16
 LIST OF FIGURES

Figure 1 Percentage distribution of patients according to the age 41

Figure 2 Percentage distribution of patients according to the gender 45

Figure 3 Lipid profile of patients of group A and group B 52

17
LIST OF ABBREVIATIONS

18
 CHAPTER I - INTRODUCTION

1.1 Background of the study

Human body is complex machinery and for maintaining the homeostasis of various organ and
organ system. Any undesirable change will disturb the balance resulting in diseased state.
Lipids are fats in the blood stream, commonly divided into cholesterol and triglycerides.
Cholesterol circulates in the bloodstream and is involved in the structure and function of cells.
Triglycerides(TG) are best viewed as energy that is either used immediately or stored in fat
cells.TG are manufactured in the liver from the foods or by being absorbed from the intestine
(Ankur et al., 2012). Virchow in 19thcentury who identified cholesterol crystals in
atherosclerotic lesion and stated that endothelial cell injury initiates atherogenesis (Ankur et
al., 2012). In a modification of this hypothesis it was proposed that the endothelium normally
influences the behaviour of arterial smooth muscle cells by providing a barrier to the passage
of plasma proteins and that the major effect of haemodynamic or other factors that injure
endothelium is to reduce the effectiveness of the barrier (Cross and Glomset, 1976) Arteries
are normally smooth and unobstructed on the inside, but in case of increased lipid level, a sticky
substance called plaque is formed inside the walls of arteries. This leads to reduced blood flow,
leading to stiffening and narrowing of the arteries. It has been proved that elevated plasma
levels of cholesterol and of LDL are responsible for atherosclerosis in man, and
epidemiological data suggests that elevated plasma levels of HDL have a protective effect
(Brundy and Vega, 1988).

19
CHAPTER II – LITERATURE REVIEW

20
 CHAPTER III - MATERIALS AND METHODS

3.1 Plant Materials

The new herbal formulation consists of three plants materials given in the Table 5. All plant
materials were collected by patients as a daily home need.

Table 6: Plant materials used in the new formulation

Scientific Name Family Name Sinhala Name Sanskrit Name Parts Used
Allium sativum Alliacea Sudalünu Lañuna Bulb
Piper nigrum Piperacea Gammiris Marica Nuts
Murraya koenigii Rutacea Karapiïca Kälañäka Leaves

3.2 Criteria for the assessment

Assessment was done on the basis of clinical observations including the estimation of blood
pressure, pulse rate and body weight and biochemical investigations, which included lipid
profile.

3.2.1 Assessment of serum lipid levels

Lipid profile is a panel of blood tests that serves as an initial broad medical screening tool for
abnormalities in lipids, such as cholesterol and triglycerides. The results of this test can identify
certain genetic diseases and can determine approximate risks for cardiovascular disease, certain
forms of pancreatitis, and other diseases.

The lipid profile typically includes, Low-density lipoprotein (LDL), High-density

lipoprotein (HDL),Triglycerides and Total cholesterol. Using these values, a laboratory may
also calculate, Very low-density lipoprotein (VLDL), Cholesterol :HDL ratio. Traditionally,
most laboratories have required patients to fast for 9–12 hours before screening. However,
recent studies have questioned the utility of fasting before lipid panels. VLDL may be
calculated using the Friedewald's equation:

VLDL = Triglycerides/5
VLDL = Total cholesterol – (HDL + LDL)

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3.2.2 Sampling techniques
Serum cholesterol estimation can be performed on a random sample of blood whereas samples
required for triglyceride estimations (and for calculation of LDL cholesterol) have to be taken
after the patient has fasted for at least 12 hours (fat-free fluids permissible). Ideally, blood
samples should be taken after the patient has been sitting for 5 minutes. The tourniquet should
be applied only briefly and should be released before drawing the venous blood sample. Testing
should be avoided within 3 weeks of a minor illness or within 3 months of a major illness or
operation, although it is valid to measure cholesterol in a blood sample taken within 24 hours
of the onset of a myocardial infarction. Similar techniques should be used at each successive
measurement. Despite such standardization, biological variation in blood lipid levels
investigated two reasonably consistent readings before start the research, and one after 2
weeks.

3.3 Selection of patient

All patients were selected from Gampaha Wickramarachchi Ayurveda HospitalZs

Hyperlipidaemic clinic. All selected cases had been treated with allopathic medicine previously
by qualified practitioners and consultants at their medical clinics. Patients had voluntarily
visited the Hyperlipidaemia clinic at Gampaha Wickramarachchi Ayurveda Hospital with the
intention of having medical advice for unsuccessful controlling of Hyperlipidaemia. Adverse
effects of treatment were the prime cause of seeking alternative method of Hyperlipidaemia
control.

3.3.1 Criteria for the diagnosis of hyperlipidaemia

Patients were diagnosed on the basis of the lipid profile. Lipid profile showing any one or more
of the following criteria was considered in the diagnosis of hyperlipidaemia.

22
Table 7: Lipid profile reference range (NCEP, 2001).

Total Cholesterol Desirable : <200 mg/dl

Borderline high : 200-239 mg/dl
High: : >239 mg/dl

Triglycerides Normal: :<150mg/dl

Borderline high : 150-199 mg/dl
High : 200-499 mg/dl
Very High >500 mg/dl
LDL Cholesterol optimal :<100 mg/dl
Near optimal to above : 100-129
mg/dl
Borderline high : 130-159 mg/dl
High : 160-189 mg/dl
Very High :> 189 mg/dl
HDL Cholesterol Low: :< 40mg/dl
Desirable :>59mg/dl

3.3.2 Exclusion criteria

Patients those who have evidence of Myocardial Infarction, CVA, IHD or any major illness
like insulin-dependent diabetes mellitus, renal insufficiency or a history of untreated thyroid
disorder were excluded. Pregnant females, lactating mothers were also excluded.

3.3.3 Inclusion criteria

Both male and female patients, aged between 20-60 years having evidence of elevated serum
lipid profile without conditions described in section 2.3.2, body mass index (BMI) of <40 were
selected for this study. Patient showed the poor lipid control on allopathic medication and
withdrawn from medication for more than three months were also selected for this study.

3.4 Research Design

This clinical study was a randomized prospective cohort study. The selected patients according
to the selection criteria described in the section 2.4 were randomly assigned into two groups
(Group A and Group B) consisting of 20 patients for each. The patients of group A were treated
with New Herbal Formulation and prescribed dietary management and the patients of group B

23
were instructed to follow the prescribed Dietary management (Group B) during the period of
14 days.

Insert a flow chart

3.5 Method of preparation, Dosage and Administration of Herbal Formulation

3.5.1 Method of Preparation of New Herbal Formulation

Allium sativum( Garlic) - 5grms (undamaged 2 lobes)

Piper nigrum (Pipper) - 5grms (15 nuts)

Murraya koenigii ( curry leaf) - 10grms (10 leaves)
Cold water - 125 ml
All patients of group A were instructed and convinced properly to identify and collect the
collect herbal materials and to measure required amount of materials. Patients were instructed
to peel out the skin of garlic lobes with causing damages to the lobes. Then they were instructed
to pour the required volume of cold water into a electric blender cup and to add the peeled
garlic lobes, curry leaves and black pepper as prescribed in the formula. Then they were
instructed to blend the materials until to obtain a blended mixture of herbal formulation and to
keep it in the refrigerator at the temperature below 40C until for use.

3.5.2 Dosage and Administration

Patients of group A were instructed to take 2 table spoonful of previously prepared mixture of
new Herbal Formulation diluted with 100ml of cold water with three main meals (Breakfast,
Lunch and Dinner) of a day for consecutive 14 days. In addition to this preparation patients

24
were instructed to follow the prescribed method of dietary management given in section 2.7.3.
The patients of group B were instructed to follow the method of dietary management only.

3.5.3 Dietary management

Patients were instructed to choose unsaturated fats (olive oil or canola oil instead of coconut
oil), whole grains (whole wheat bread or brown rice), fruits and vegetables, which are high in
fiber and to limit cholesterol rich diet including egg yolks, whole milk products and organ
meats ( Anderson and Davidson, 2000)

3.5.4 Monitoring of patients

All patients were monitored for clinical changes, adverse effects and proper use of prescribed
preparation of new herbal formulation and dietary management weekly interval for 2 weeks
and after 14 days patients were advised to get a serum lipid profile analysis from the
recommended clinical laboratory.

3.6 Data Processing and Analysis

Analysis of variance followed by student's T-Test were done using the Minitab statistical
software package. The results were considered as significantly different when the p<0.05. The
values lipid parameters were expressed as the mean ± standard error of mean (SEM).

25
 CHAPTER IV - RESULTS

4.1 Age and gender wise distribution of patients

40 patients of having confirmed hyperlipidaemic conditions were selected for the present study
and all patients were between 31 – 60 years of age. The majority of patients were between 51-
60 years of age (Table 9, Figure 1). 57.5% of patients selected for the study were male. The
female:male ratio was 1:1.35 (Table 10, Figure 2).

Table 8– Age distribution of selected patients

No Age Total Percentage

1 21-30 00 00%
2 31-40 08 20%
3 41-50 12 32%
4 51-60 20 48%

21-30 31-40 41-50 51-60

Figure 1 -Percentage wise distribution of patients according to the age

26
Table 9: Gender wise distribution of patients

No Gender Total Percentage

1 Female 17 42.5%
2 Male 23 57.5%

Female
42%

Male
58%

Figure 2 -Percentage distribution of male and female patients

4.1 Serum lipid concentrations of patients

A sample of chronic cases of Hyperlipidaemia was selected for this respective study with the
objective of evaluating the efficacy of Group A separately with Group B. We compared the
efficacy of New herbal Formula with Dietary Management ( Group A) vs. only Dietary
Management ( Group B) as Hyperlipidaemia.

At the first visit to the clinic, almost all patients ( n=40, age=21-60) of the sample had shown
poor cholesterol control (Group A- 274.2 ±6, Group B- 258.6±7.0) on the first visit to the
clinic even though they had been treated with allopathic medicine. All patients had been
investigated for their Lipid profiles and blood pressure levels regularly.

Before the commencement of study all patients showed highly elevated serum levels of total
cholesterol and LDL. The concentration of serum triglyceride was at borderline high and the
HDL concentration was near to the margin of low level. The TC/HDL or risk factor was
considerably high (Table 8). After 14 days treatment, patients of the group A showed

27
significant decrease in serum total cholesterol level in comparison to the level of same
parameter before the treatment (p<0.05) but the patients of group B did not show considerable
reduction of serum total cholesterol level compared to that of before treatment of same group.

Table 10: Serum lipid concentrations of patients of Group A and Group B (Before Treatment).

Groups (n = 20) TC TG HDL LDL TC/HDL

Group A 258.6±7.0 a 182.8±8.2 a 44.2±0.7 a 193.4±5.8a 6.5±0.2 a
Group B 274.2±6.0 a 187.8±14.4 a 44.5±1.4 a 193.4±5.8a 5.9±0.2 a

In a column, data are presented as Mean±SEM of 20 patients per each group. In each column,
data indicated by different superscript letters are significantly different from each other
(ANOVA; Tukey's test: p<0.05)

300
a
a
250
Serum lipidconcentrations (mg/dl)

a a a
200 a Group A

150
Group B

100

a a
50
a a
0
TC TG HDL LDL TC/HDL

Figure 3-: Serum lipid concentrations of patients of Group A and Group B (Before Treatment).

Each bar represent the Mean±SEM of 20 patients of each group. The bar indicated by different
letters are significantly different from each other (ANOVA, TukeyZs Test: p<0.05)

28
 CHAPTER V - DISCUSSION

These results demonstrate favorable alteration in lipid profile in subjects with mild
hyperlipidaemia during the period of oral administration of New herbal formulation with
dietary management. The lipid fraction alterations are a reflection of the summation and
synergism of the individual effects of New herbal formulation and dietary management in
subjects who had an abnormal lipid profile and who continued their usual dietary habits during
over a 2-week period in each regimen.

A 37.5% (208.6±7.7, p<0.05) reduction was noted in total cholesterol levels during New herbal
formulation with dietary management (group A) and there was a 3.34% (250±6.8) reduction of
total cholesterol during dietary management (group B). Earlier reports demonstrated 5% to 6%
reduction of total cholesterol after 4 weeks of garlic supplementation alone (Jain et al,1993;
Harenberg, et al., 1998). Triglyceride levels were consistently lowered by 38.44% (129.5±7.4
(p<0.05) in this study in Group A and 2.35% (183.3±13.3) reduction in group B. Previous
studies with fish oil supplementation report 30% reductions in total triglycerides with low-fat
diets, respectively (Nordoy, et al., 1993). The Group A resulted in a significant reduction of
26.47% (175.3±9.0 (p<0.05) in LDL-cholesterol and Group B result that 4.21%. (185.3±6.3 ).
Previous studies showed that w-3 fatty acids and fish oils may result in a small increase (5% to
8%) of LDL (Mori et al., 1994; Haris, 1984).

In the present study, there was no significant change in the average total HDL levels when all
subjects were considered, although there was a trend toward an increased in a subgroup
representing 7.81% (47.6±0.71 .(p>0.05) of the subject in Group A. Group B increased that
1.77% (45.3±1.2).

Conclusions and Recommendations

When compare serum lipid levels of patients of group A with group B, there was a significant
difference among before and after treatments. According to results observed in present study it
could be concluded that the population mean of data regarding to all parameters before
treatment is different from the population mean of data regarding to all parameters after
treatment of both groups. Considering the overall results of present study and comparing with
the results of previous studies, it is evident that the short term administration of New Herbal
Formulation has shown significant effect in decreasing the elevated serum lipid levels (except
to the HDL levels) than the effect of given dietary management alone in hyperlipidaemic

29
patients. The evidences revealed from this prospective study provide strong scientific
background for the randomized clinical trial for further evaluation.

The plant materials, which lacks descriptive information can be subjected to more analytical
studies and can be directed to be explained in the term of Ayurveda by the expertise in the field.
As far as the conclusion of the above chapters are concerned, several suggestions can be
introduced for further research.

1. Chemical analysis of the raw materials leading to study the effects of identified
molecules on different metabolic pathways could be suggested as prime important for
the determination of mechanisms of actions.

2. Replication of the study in involving a larger sample during a lengthier period of time
for the determination of effects and efficacy of new herbal formulation

30
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Ankur, R., Nidhi, D., Seema, R., Amarjeet, D., Ashok, K., (2012). Hyperlipidemia- a deadly
pathological condition. International Journal of Current Pharmcology Research, 4:15-18
Brundy, S. M. and Vega, G. L., (1988). Hypertriglyceridemia: causes and relation to coronary
heart disease, Journal of American Medical Association, 14: 249-64.
Cross, R. and Glomset, J. A., (1976). The pathogenesis of atherosclerosis. New England
Journal of Medicine, 295: 369-77

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