SYNOPSIS PROFORMA

Maharashtra University of Health Sciences, Nashik

TITLE
A clinical study on efficacy of Aamalakyavaleh in the management of
Bahupitta Kamala W.S.R to Hyperbilirubinaemia (Jaundice).
In
KAUMARBHRITYA TANTRA
Synopsis of Dissertation of M.D. (Ayu.)
Ayurved Vachaspati
IN
KAUMARBHRITYA TANTRA
Name Of the candidate:- Vd. Balaji Vilas Tayde.
B. A. M. S.
Year of Admission: - 2015-2016

HOD
Prof. Vd. K. S. Ratnaparkhi
M.D. (Ayurved)

Guide
Vd. K. S. Ratnaparkhi
M.D.(Ayurved)

Name of the institute

C.S.M.S.S. Ayurved Mahavidyalaya,
Kanchanwadi, Aurangabad.
Year of submission: 2015 2016
Application by the candidate for submission of synopsis
Name: Vd. Balaji Vilas Tayde.
Address: CSMSS Ayurved Mahavidyalaya,
Aurangabad.
To,

The controller of the examination,

M.U.H.S. Nashik
Through
Principal,
Vd. S.G. Deshmukh.
C.S.M.S.S. Ayurved Mahavidyalaya,Kanchanwadi
Sub: Submission of synopsis.
Respected sir/madam,
Submitting herewith a copy of synopsis in Kaumarbhritya Tantra For your
observation & approval.
Thanking you.
Vd. Balaji Vilas Tayde.
(B.A.M.S.)
Forwarded by
H.O.D.

GUIDED BY

Prof. Vd. K. S. Ratnaparkhi.

Vd. Karuna s. Ratnaparakhi.

M.D. (Ayurved)

M.D. (Ayurved)

C.S.M.S.S. Ayurved Mahavidyalaya,

C.S.M.S.S. Ayurved Mahavidyalaya,

Kanchanwadi, Aurangabad

Kanchanwadi, Aurangabad
Principal
Vd. S.G. Deshmukh

C.S.M.S.S. Ayurved Mahavidyalaya, Kanchanwadi,Aurangabad.

Appendix A'
FORMAT FOR SUBMISSION OF TOPIC BY P.G. STUDENT
Academic Year

2015 2016

Name of the P.G. College

C.S.M.S.S. Ayurved Mahavidyalaya, Kanchanwadi.

Department

Kaumarbhritya Tantra

Name of the Guide &

Vd. K. S. Ratnaparkhi

College Name
Contact Number of Guide
To,

C.S.M.S.S. Ayurved Mahavidyalaya, Kanchanwadi.

9421096188
Through Proper Channel only

The Registrar
M.U.H.S., Nashik-422004
Sub.: Submission of title of synopsis
Respected Sir/Madam,
I Vd. Balaji Vilas Tayde.
registered for M.D. in the 2015-16 batch under the guidance of Vd. Jagruti
Kharatmal, Reader, M.D., Kaumarbhritya Tantra department, C.S.M.S.S Ayurved
Mahavidyalaya, Kanchanwadi, Aurangabad.
I am due to appear for M.D. Ayurved (Pre.) in June 2016. I am submitting
here with Title of synopsis as mentioned below & as suggested by my aforesaid
guide.
TITLE OF SYNOPSIS
A clinical study on efficacy of Aamalakyavaleh in the management of Bahupitta
Kamala W.S.R to Hyperbilirubinaemia (Jaundice).

Kindly accept and register my Title of Synopsis.

Vd. Balaji Vilas Tayde.
(Candidate Name & Signature)
Guide

H.O.D.

Vd. K.S. Ratnaparkhi

Vd. K.S. Ratnaparkhi

(Guide Name & Signature)

(HOD Name & Signature with Dept. Seal)

]Vd.S.G. Deshmukh
(Signature & Seal of Dean of College)

APPENDIX B
REPORT OF INSTITUTIONAL ETHICAL COMMITTEE
Department
Candidate Admitted Year

Kaumarbhritya Tantra
2015-2016

Course and Subject

College Name And Address

M.D. Kaumarbhritya Tantra

C.S.M.S.S. Ayurved Mahavidyalaya, Kanchanwadi,
Aurangabad.

Reference No:

Date: - / /2016

To,
Vd. Balaji Vilas Tayde.
Kaumarbhritya Tantra Department.
C.S.M.S.S. Ayurved Mahavidyalaya, Kanchanwadi.
Subject: - Research Proposal
Entitled TITLE
A clinical study on efficacy of Aamalakyavaleh in the management of
Bahupitta Kamala W.S.R to Hyperbilirubinaemia (Jaundice).
Ref: - A copy of synopsis.

Dear Student,
The above mentioned research proposal of Title of synopsis was discussed in
the Ethics Committee meeting held on / /2016, at

, at our College.

Ethics Committee has unanimously approved your title of Synopsis. This work
will be done under the guidance and supervision of your guide Vd. Jagruti Kharatmal
Dr. S.C.Bhoyar.
Chairperson, Ethics committee.
C.S.M.S.S. Ayurved Mahavidyalaya,
Kanchanwadi, Aurangabad.

CERTIFICATE

This is to certify that Vd. Balaji Vilas Tayde.

is student of M.D. prelim under my guidance and supervision.
The title for dissertation is Entitled:
A clinical study on efficacy of Aamalakyavaleh in the management of
Bahupitta Kamala W.S.R to Hyperbilirubinaemia (Jaundice).

I recommend that the synopsis may be forwarded for approval for degree of Ayurved
Vachaspati in Kaumarbhritya Tantra under Maharashtra University of Health
Sciences, Nashik.
Guided by,
Vd. Karuna S.Ratnaparkhi.
C.S.M.S.S. Ayurved Mahavidyalaya,
Kanchanwadi, Aurangabad.

Check List
(For Submission of Proposal to the University)
1

Academic Year

2015-2016

Subject

Kaumarbhritya Tantra

Name of the Student

Vd. Balaji Vilas ayde.

Eligibility

Yes/No

Name of Guide & Designation

Vd. Karuna S. Ratnaparakhi.

Yes

Head Of Kaumarbhritya Dpt.

5

Recognition of Guide

Yes/No

Yes

Yes/No

Yes

Yes/No

Yes

Yes/No

Yes

(If yes, please mention MUHS

letter NO. & Date)
6

Fee
(Please mention consolidated

DD No.& Date)
Appendix A
(Format for submission of topic

by P.G. Student)
Appendix B
(Report of Ethics committee)

Sign
Dean/ Principle
Seal of College

TITLE

A clinical study on efficacy of Aamalakyavaleh in the

management of Bahupitta Kamala W.S.R to
Hyperbilirubinaemia (Jaundice).

INTRODUCTION

A Ayurveda is a science of life. It is indefinably valuable gift given to mankind

by Lord Bramha and our ancient Acharyas. Ayurveda not only treat disease but also
gives emphasis on preventive aspect of disease. So it is called science of Life and
Longitivity
Kamala is one of the prominent condition which attracts attention of modern day.
students of medicine as it is seen frequently in various forms today; irrespective of
age, sex, socio-economical condition, education etc.
Kamala is mentioned in Ayurvedic Texts mainly in Brihattrayis as 16th chapter of
charka samhitachikitsa sthana.,44th chap. of Sushrutauttartantra, and 13 th chapter of
nidansthana.16th chapter of AshtangHrudaya, chikitsasthana. In all mentioned above
the description of kamala is came along with PanduRog.

CLASSIFICATION KAMALA1 Kamala has been classified as

1. Koshthashrita Kamala (Bahupitta Kamala)
2. Shakhashrita Kamala (Ruddha Path Kamala)
Bahupitta Kamala is mainly due to dushti of pittadosha with dushti of rakta,
mansadhatu&yakrit as 'moolsthana'.
The main causes of Bahupitta Kamala are pittavardhakaushnatikshnaaahara, vihara,
manasikahetus and madyapana etc.
Bahupitta Kamala presents various features but main feature is haridra-varna of
netra, tvak, purisha&mutra. According to that Kamala can be correlated with
Hyperbilirubinaemia or Jaundice in modern era.

NEED FOR STUDY:

Kamala is a common disorder seen in Urban as well as Rural areas with
poor hygiene and sanitation.Number of patients suffering from kamala is quitely high.
Although special reference of Yog Ratnakar has explained Aamlakavaleh in thre
management of Bahupitta kamala & no research work done on this Kalpna.

AIM AND OBJECTIVES:Aim :-

To study the efficacy of Aamalakyavaleh in Bahupitta Kamala. W.S.R. to

Hyperbilirubinaemia (jaundice).

OBJECTIVES:1. To study the etiopathology of Bahupitta Kamala according to Ayurveda and

modern science.
2. To compare the efficacy of Amalakyavaleh and Dhatriavaleha inBahupitta
Kamala.
3. To study the effect of Aamalakyavaleha on Sr. Bilirubin level.

PLAN OF WORK:1) Review of Literature:

The review of literature includes a thorough screening of Ayurvedic texts,
contemporary Ayurvedic literature and Modern texts.
Drug Profile:Detailed description of contents of Aamalakyavaleh, their properties and
pharmaco-therapeutic action will be mentioned.
2) Clinical Study:Here the drug under trial will be put into clinical evaluation. To facilitate easy
diagnosis, detailed clinical examination will be conducted on the basis of proforma
specially prepared for this purpose.Required investigations too will be done. All the
data that will obtain will becomputed and assessed statistically for results and will be
presented.

PREVIOUS WORK DONE2:1. A clinical study on Yakrit rogas w.s.r to Kamala in children. 1995- Jamnagar
2. Effect of Amalaki in Navjat shishu Kamala. 2004- Varanasi
3. To study efficacy of Trifala Kashaya in children w.s.r. to Bahupitta Kamala 2006Nanded

Null Hypothesis :
H0 There is no significant effect of Aamalakavaleh in Bahupitta Kamala.
.

MATERIALS AND METHODS:

MaterialsGroup A 3 |
||
|
||
|
||
|
||
- .... 116-119

sr.

Drugs

Latin name

Rasa

Virya

Vipak

Guna

Karma

Madhur

Guru,Ru

Yakrut

no
.
1

Aamalaki4

Embelica

Pancha Ras Sheet

officinalis

Pippali5

Piper
Longum

(Lavan

ksha,

uttejak,R

Varjit)

Sheet

ochan ,
Deepan
Yakrut

Katu

Anushna- Madhur

Laghu ,

(Shushka)

sheet

Snigdha, uttejak,
Tikshna

Deepan,

Yashtimadhu6

Glycerrhiza

Madhur

Sheet

Madhur

Rechan
Guru,Sni Chardini

Draksha7

Glabra
Viis Vinifera

Madhur

Sheet

Madhur

gdha
grahan
Snigdha, Rakta

Shunthi8

Zingiber

Katu

Sheet

Madhur

Officinalis
6

Vanshalolach
an9

7
8

Bambusa
arundinace

Madhu10
Sharkara

11

Guru,Mr

pitta

udu
Laghu ,

shamak
Rochan

Snigdha, ,Deepan
Madhur ,

Sheet

Madhur

Kashya

Apisin

Madhur

dica
-

,Kashay
Mahur

Ushna
Sheet

Madhur
Madhur

Tikshna , Pachan
Rukshna Deepan,
,Laghu,

Pachan,

Tikshna

Rakta

Guru

shodhak
Raktapitt

Laghu,

aghna
Pittagna

Control GroupGroup B Dhatri Avaleh12

Method of preparation:The drug will be prepared as per standard procedure mentioned for preparation
of Avaleha.
Dose-

As per age according to Sharangdhar Samhita in 2 divided doses.

Drug Standardization:Standardization of the drug will be done in an authentic laboratory.

Drug Regimen -

Group

A (trial)

B (control)

Age Group

5-16 years

5-16 years

Sex
Drug Given

Both
Aamalakyavaleh

Both
Dhatri Avaleh

Doses13

As per Age

As per Age

Anupan14

According to sharangdhar samhita

According to sharangdhar samhita

Duration
Route of

2 divided doses
For 30 Days
Oral (Madhya Kal)

2 divided doses
For 30 Days
Oral

On 15th and 30th day

On 15th and 30th day

Adm. And
Kala 15
Follow up

Dose of Amalakavaleh and Darvyadileh :Doses will be as per Age Division ,According to Sharangadhar samhita And
Divided in 2 Doses

DOSE OF AMALAKYAVALEH AND DHATRI AVALEH9 :-

:
:
: : :
: :
::


.. . . /-

CONSENT OF THE PATIENT:Written informed consent of parents or guardians of the patients will be taken in the
language best understood to them.

CRITERIA FOR SELECTION OF PATIENTS:60 diagnosed patients from patients attending the OPD and IPD of
Kaumarbhritya Department of our institute Age group between 5 to16 year

irrespective of caste, religion, sex, socioeconomic status will be randomly selected

and divided into two groups.
Group A: (30 patients) Trial Group.
Group B: (30 patients) Control Group.

Inclusion Criteria:Age group -5 to 16 year

Sex- Both sex
Patients having sign & symptoms of Bahupitta Kamala
Patients having sr. bilirubin level 2 to 10 mg/dl
Exclusion Criteria:Age group - <5 yr. and > 16 yr.
Patients having sr. bilirubin level > 10 mg/dl
Having obstructive pathology (Ruddha Path Kamala)
Having any complication
K/C/O HbsAg positive, HIV positive, liver abscess.

Subjective Criteria16 :NETRA PEETATA

MUTRA PEETATA
TWAKA PEETATA
CHHARDI ( VOMITTING )
DAURBALYA (WEAKNESS)

Objective Criteria7 :Kamala assessed objectively by laboratory methods on the basis of values of
sr. bilirubin level.

CRITERIA FOR ASSESSMENT17:-

Subjective assessment
1

NETRA PEETATA

4 CHHARDI
Absent ( VOMITTING )

No vomiting
Can be seen in Bright Sunlight

01

LessCan
thanbe3 seen
episodes
in Sunlight

12

3-6 episodes
Can be seen
per day
without Sunlight also

23

More than 6 episodes per day

MUTRA PEETA
Normal urine colour

Yellowish coloured urine

Dark yellow coloured urine

Highly dark yellow coloured urine

3 TWAKA PEETATA
Absent

Can be seen in Bright Sunlight

Can be seen in Sunlight

Can be seen without Sunlight also

5 DAURBALYA (WEAKNESS)
Can do routine work

Mild weakness after routine work

Perform routine work with difficulty

Can not perform routine work

Percentage of relief in symptoms and signs with respect to each of the patient will be
as follows and will be classified as per definition of cured, markedly improved,
Improved and Unchanged

STUDY DESIGN:Open randomized controlled trail design will be studied.

SCREENING OF SUBJECTS FOR INCLUSION

COUNSELING AND INFORMED CONSENT

RANDOMIZATION

GROUP A TRIAL GROUP

AMALAKYAVALEH

GROUP B CONTROL GROUP

DHATRI AVALEH

INITIAL ASSESSMENT
DIETARY &
BEHAVIORAL ADVICE COMMON TO ALL GROUPS

INTERVATION

Intermediate Follow ups on 15th and 30th da

ASSESSMENT

STATISTICAL ANALYSIS

CONCLUSION

Study End Point:This study will be conducted from baseline up to 30 days of intervention.
STATISTICAL METHODS:
1. All observation will be noted in the observation table.
2. Representation of Results appear in both groups.
3. Data thus generated will be analyzed statistically.
4. Observations will be analyzed and statistical study will be done by applying
appropriate stastistical test.
Probablity and Level of Significance
Outcome of the treatment is expected to be significant at 5%(p<0.05) in all
symptoms which will be critically evaluated at the end of the study.

Total effect of TherapyCured

- 76 to 100% relief in signs & symptoms of patients

Markedly improved - 51 to 75% relief in signs & symptoms of patients

Improved

-26 to 50% relief in signs & symptoms of patients

Unchanged

-0 to 25% relief in signs & symptoms of patients

Ethical AspectSubject will be included in study after permission from Ethical Committee.
L.A.M.A.
Those patients who left the treatment before advised duration or
who didnt followed instruction about the study will be considered
as left against medical advice (L.A.M.A.)

OBSERVATIONS:Observations will be drawn on the subsequent follow ups from

symptomatology and objective parameters.
Follow up
Both groups will be examined time to time for expected results.
1st Follow up: 15th Day
2nd Follow up: 30th Day

DISCUSSION :Results obtained will be analysed and discussed in this section.

CONCLUSION:
Conclusion will be drawn on the basis of readings obtained before and after
treatment by using statistical methods.
Statistical Analysis-

Wilcoxon Sign Rank test and Paired t test will be applied for subjective and objective
criteria respectively.

9. Bibliography
1

Charak Samhita

With Ayurved Dipika commentary by Chakrapanidatta

Chaukhamba surbharati prakashan ,Varanasi by Vaidya
Yadavaji Trikamaji Acharya 2008

Sushrut Samhita

With

Nibandhasangraha

and

Nyayachandrika

commentary Chaukhamba orientalis, Varanasi by

Vaidya Yadavaji Trikamaji Acharya 2002
3

Ashtanga Hriday

Marathi

translation

of

Ashtang

Hridaya

Anmolprakashan pune by Dr. Gadre

4

Yogaratnakar

With

vidyotini

hindi

commentary

Chaukhamba

prakashan , Varanasi by Vd. Laxmipaty shastri

5

Bhaishjyaratnavali

Kaviraj Govinddas sen Virachit, Chaukhamba surbharati

prakashan, Varanasi

Dravyaguna vidnyan Chaukhamba bharti academy by Vd. Priyavat Sharma

vol. 2

Nelson Textbook Of Nelson Textbook Of Pediatrics (Elsevier)First South

Pediatrics Volume-2

Asian Edition

Sharangdhar

Jivanprada

Samhita
9

Bhav
NIghantu

Hindi

Commentary

by

Smt.Shailaja Shrivastav.

Prakash Shri Bramha Shankar Mishra , Chaukhamba Prakashan.

Refrences-

1. Charak Samhita Bramhanand Tripathy Chaukhamba Publication Vol-02

page no.596, Shlok no.chi.16/36
2.Research in Ayurveda online Baghel database-https://researches-inayurveda.co.in
3.Yogratnakar- vidyotini hindi commentary Chaukhamba prakashan , Varanasi by
Vd. Laxmipaty shastri . - Pandurog Nidan page no.345.
4. Bhav Prakash Nighantu Shri Bramha Shankar Mishra , Chaukhamba
Prakashan.Page 10
5. Bhav Prakash Nighantu Shri Bramha Shankar Mishra , Chaukhamba
Prakashan.Page 15, Shlok no.55-58.
6. Bhav Prakash Nighantu Shri Bramha Shankar Mishra , Chaukhamba
Prakashan.Page no.65,Haritkyadi Varga, shlok no.145-46.
7. Bhav Prakash Nighantu Shri Bramha Shankar Mishra , Chaukhamba
Prakashan.Page no. 585 ,Amradi varga shlok no.111-14
8. Bhav Prakash Nighantu Shri Bramha Shankar Mishra , Chaukhamba
Prakashan.Page no.13 ,Haritakyadi Varga ,Shlok no.50-52.
9. Bhav Prakash Nighantu Shri Bramha Shankar Mishra , Chaukhamba
Prakashan.Page 58, Ikshu Varga,Shlok no.117.
10. Bhav Prakash Nighantu Shri Bramha Shankar Mishra , Chaukhamba
Prakashan.Page no.788,Madhu Varga Shlok no.1-5.
11. Bhav Prakash Nighantu Shri Bramha Shankar Mishra , Chaukhamba
Prakashan.Page no.792-796, Ikshu Varga,Shlok no.1-2 and 30.
12.Thesis
13.Sharandhar Samhita Purva Khanda 6/49-52, Jiwanpradhnya Hindi
Commentary by Smt.Shailaja Shrivastav.
14. Sharangadhar Samhita Madhyam Khanda 8/4 , Jiwanpradhnya Hindi
Commentary by Smt.Shailaja Shrivastav .
15. Charak Samhita ,Bramhanand Tripathi,Varanasi Vol.-2 Page no. 1059
Shlok no. chi.30/99.
16.Charak Samhita ,Bramhanand Tripathi,Varanasi Vol.-2 Page no.596.
17. Nelson Textbook Of Pediatrics (Elsevier)First South Asian Edition
18. thesis

CASE PROFORMA
P.G. DEPARTMENT OF KAUMARABHRITYA
A clinical study on efficacy of Amalakavaleh in the management of Bahupitta
Kamala W.S.R to Hyperbilirubinaemia . (Jaundice)
--------------------------------------------------------------------------------------------------------------Scholar :Dr .Balaji Vilas Tayde.
Guide : Dr. Karuna s. Ratnaparakhi.

Name

SL. NO

Age

:Date:

Sex

: M /F

Religion

: H / M /C / J / O

Address

Diagnosis

O.P.D No

Presenting complaints:
Chief complaints:

Associated complaints:

History of Present illness:

Mode of onset
ChikitsaVrittanta for the present illness:
Hospitalization : Present / Absent (with similar compliants)
History of Past illness

School

Family History:

Birth History:
Developmental history:

Personal History:

History of Immunisation:

Examination:

GENERAL EXAMINATION
General appearance: healthy / dull / sick
Built

: poor / medium / good

Height

Weight

Temperature :
Pulse

Respiratory Rate

Pallor

: mild / mod / severe / absent

Cyanosis

: present / absent

Icterus
Lymph nodes
Tongue
Edema

: present / absent
: palpable / not palpable.
: clear/coated
: Any other findings:

SYSTEMIC EXAMINATION: ( Srotopareekshan)

Respiratory system:
Cardio vascular system:
Gastrointestinal system(P/A):
Central nervous system:
Genitourinary system :

SROTAS PARIKSHA :
Pranavaha :
Udakavaha :
Annavaha :
Rasavaha :
Raktavaha :
Mansavaha :
Medovaha :
Asthivaha :
Majjavaha:
Shukravaha :
Mutravaha :
Purishavaha:

NIDAN PANCHAK :
DIAGNOSIS:
TREATMENT :

DOSE:
DURATION :

OBSERVATIONS:Observations will be drawn on the subsequent follow ups from

symptomatology and objective parameters.

Symptoms

15th Day

30th Day

NETRA PEETATA

MUTRATA PEETA

TWAKA PEETATA

CHHARDI
( VOMITTING )
DAURBALYA
(WEAKNESS)

REMARK:
(sign)
GUIDE

(sign)
SCHOLAR

C.S.M.S.S. AYURVED COLLEGE KANCHANWADI, AURANGABAD

INFORMED CONSENT
I,Mr/Mrs. .......................................................................................... Mother / Father of
Baby Age ...........yrs. Hereby give my voluntary consent to under examination and
subsequent treatment the project under
A clinical study on efficacy of Amalakyavaleh in the management of Bahupitta
Kamala W.S.R to Hyperbilirubinaemia . (Jaundice)
Project undertaken by Vd.Tayde Balaji Vilas.
I have been properly informed and an aware of nature of possible
unwarranted arising effect of the medication being used.
I have been also informed that I may refuse to participate or withdraw my
baby from this research at any time and it will not affect in any way the treatment my
baby is receiving.
I have given my consent in complete consciousness and without being under
any pressure.

Date :
Name of babys Mother /Father

CANDIDATE
Vd.Tayde Balaji Vilas .
B.A.M.S.

Sign / Thumb

GUIDE
Vd. Karuna s. Ratnaparakhi.
M.D. (AYU)
HOD
Kaumarabhrityatantra

,, .

./............................................................. ........... ,
............................................................. ...........................
// /, .
A clinical study on efficacy of Amalakyavaleh in the management of Bahupitta
Kamala W.S.R to Hyperbilirubinaemia . (Jaundice)
: ,
.
,

.
.
.
:........................

/
: