BHARATI VIDYAPEETH
(DEEMED TO BE UNIVERSITY)PUNE (INDIA)
COLLEGE OF AYURVED, PUNE
APPLICATION TO“INSTITUTIONALETHICS COMMITTEE”
FOR APPROVAL OF A RESEARCH PROJECT
1. Basic data
Name/s of Applicant
Address for correspondence:
(With email ID & phone
number)
Permanent address for future
correspondence
Project Title
Principal investigator
Address of PI
Co- investigator
Address of Co- investigator
Sponsoring Organization
Site contact details (address/
phone no of place where
research work will take place)
Date of application
submission
DR.BHARATI MALHARI HAKE
KUDALE PLAZA,DHAYARI PHATA,SINHGAD
ROAD ,PUNE.
email-bhartihake3167@gmail.com
MOB NU.-9970745789
A/P KEDGAON STATION; TAL-DAUND ;DIST-
PUNE
‘STUDY THE EFFICACY OF DHANVANTARA
TAIL AS ABHYANGA IN PROMOTING NORMAL
GROWTH AND DEVELOPMENT IN
PREMATURE INFANTS’
DR.BHARATI MALHARI HAKE
(MD SCHOLAR)
DEPARTMENT OF KAUMARBHRITYA-BALA
ROGA,BHARATI VIDYAPEETH (DEEMED TO
BE UNIVERSITY),COLLEGE OF AYURVED
AND HOSPITAL,PUNE-SATARA ROAD ,PUNE-
43
DR.PREETHAM PAI
DR.RITESH JAIN
DEPARTMENT OF KAUMARBHRITYA-BALA
ROGA,BHARATI VIDYAPEETH (DEEMED TO
BE UNIVERSITY),COLLEGE OF AYURVED
AND HOSPITAL,PUNE-SATARA ROAD ,PUNE-
43
SELF -SPONSORED
DEPARTMENT OF KAUMARBHRITYA-BALA
ROGA,BHARATI VIDYAPEETH (DEEMED TO
BE UNIVERSITY),COLLEGE OF AYURVED
AND HOSPITAL,PUNE-SATARA ROAD ,PUNE-
43
03/02/2018
2. Back ground information (150-200 words)
Infants who are born before 37 weeks of gestation age are called as ‘Premature’
.As compared to term baby premature shows more acceleration of maturation,
especially in visual and auditory attention as well as in alertness and sleep
disorders.

There is always a problem in normal growth of premature babies like

neuromotor development, cognition and seizures, hearing, behavior problems,
learning disabilities, feeding and nutrition, physical growth, nutritional status
etc therefore after discharge from hospital babies should be regularly followed
up for assessment of all these problems.

Abhyanga is non-invasive procedure that has positive effect on normal physical

growth and development of premature neonates including weight gain,
promotion of normal development, decreases stress behavior, improves sleep.

Unfortunately 10 to 12% of Indian babies are born preterm. And 4% of babies

with developmental delayed.2% babies have auditory and visual problems.

In future these children are completely dependent on their parents because of

developmental delayes.Such condition can be compared with
vatavyadhi’.Snehana is the 1st line of treatment for the management of
vatavyadhi.Hence abhyanga has been selected.

Dhanvantar tail is brihaniya,dhatuvardhaniya drug which is very effective in

vatavyadhi and is specifically indicated in balarogas.. Dhanvantar tail promotes
the normal functioning of ‘vata’.
3. Aim and objectives:

Aim-
Study the efficacy of dhanvantar tail as abhyanga in promoting normal growth
and development in premature infants

Objectives-
1.To study role of Abhyanga in normal growth and development in premature
infants

2.To study the guna and karma of Dhanvantar tail in detail

3.Study the premature neonates in detail

4.Study the properties and functions of coconut oil

4. Study design

A) Open randomized controlled clinical study.

Plan of work :This study will be conducted on premature babies who are
admitted in the IPD of balaroga department of Bharati vidyapeeth ayurved
hospital pune.Premature babies who fit in the inclusion criteria will be selected
for the study.

Study population: Sample size with justification based on prevalence formula

as:-

[N=Z2P(1-P)/D 2]

Where; N=Sample size, P=Prevalence=1.96,D=0.05.

30 premature neonates will be taken as per 2% prevalence formula

Study medication:
Study drug:Dhanvantar tail will be used as study drug .Preparation will be
done from GMP certified pharmacy according to standard process as
mentioned in classical texts. The oil will be prepared and standardized using
ayurvedic pharmacopoeia of India and ayurvedic formulary of India.
Comparator: Coconut oil will be used as a comparator group. Coconut oil will
be procure from the GMP certified pharmacy /company.

Give detailed and specific information on:

4.1Selection and exclusion criteria of study participants

A.INCLUSION CRITERIA:

1)New4born babies34.1-36.6 weeks of gestational age.

2) Babies who Discharge from NICU.

3) Patients who stay near dhankawadi area

4) Babies of both sexes will be selected randomly.

5) Parents who were willing to give informed written consent, will be

included in the study

B. EXCLUSION CRITERIA

1) Babies suffering from some systemic or topical disease

2. Babies under NICU admissions, ongoing medications, congenital anomalies
and hemorrhagic disease

3) Term and Post term Babies.

4)Those with allergic skin reactions will be excluded

5) Parents who were unwilling to give informed written consent,wiil be excluded

from the study.

4.2Method of randomization:

It’s a open randomized controlled clinical study.

Patient/relative will be told to select a chit which contains numbers either 0 or
1.The patient who receives nu.1 will come under trial group and the patient
who receives nu.0 will come under control group.
4.3 Method of blinding: not applicable.

4.4Study groups: Two groups –

1. Trial group:Dhanvantar tail

2. Control group: Coconut oil

4.5Sample size in each group: 15 in each group

4.6Treatment details for each group:

Group A-Trial group –

Abhyanga by Dhanvantar tail will be given on premature babies
who are under inclusion criteria.

Group B-Control group-

Abhyanga by Coconut oil will be given on premature babies who
are under inclusion criteria.

After discharge from NICU that is 1 st day of IPD onwards till

discharge the baby will receive abhyanga from the vaidya .The
procedure will be done in draft free room for duration of 15
minutes .Warm oil (dhanvantar/coconut oil)will be used.During
the procedure the baby’s SPO2,heart rate ,respiratory rate,
temperature will be monitored.10ml of oil will be used for 1 st
month and 15ml of oil will be used for 2 nd month. After discharge
baby will receive abhyanga from trained mother or relatives for
total duration of two moths .

Duration: Each abhyanga will be done up to 15 minutes.

Dose- 10ml oil for 1month and 15ml oil for 2nd month.

follow up: daily when baby admitted in IPD and then on

10th ,15th,30th,45th,60th,90th,120thday of life.

INVESTIGATIONS- Sr.Triglyceride(before and after treatment)

4.7Outcome measures:
A] primary end points:

Normal achievement as appropriate of weight, length,chest,circumference,head

circumference is expected to seen in trial group.
Attainment of age appropriate primary reflexes ,millstones such as
head holding ,social smile, turning over is expected to be seen in trail group

B] secondary endpoints:
Improvement in feeding, sleep, wakefulness is expected to be seen in the trial
group.

5 Assessment of efficacy
5.1
A)
1.New Ballard’s scoring for assessment of gestational age for all babies .
2. Weight measures before & after treatment
3.Chest circumference
4.Head circumference
5.Length [cm]
6.Primary Reflexes
7.CDCgrading head holding
8.Social smile
9.Turning over

A.MOROS REFLEX
Absent Incomplete Complete
0 1 2

B.ROOTING REFLEX-

Absent Present
0 1

C.SUCKING REFLEX-

Absent Slow Fast

 0 1 2

D.GRASPING REFLEX

Absent Present
0 1

E.PLANTER REFLEX

Absent Present Abnormal

0 1 2

F.EYE CONTACT

Absent Present
0 1

G.ASYMETRICAL TONIC NECK REFLEX

Absent Present
0 1

H.SOCIAL SMILE

Absent Present
0 1

I. HEAD HOLDING [CDC GRADING]

Head erect Dorsal Prone Holds head Head

and steady suspension[lifts position[elevates steady while balanced at
momentarily head along on arms, lifting mother all times
with body] chest] moves
around]
1 2 3 4 5
J.TURNING OVER

Absent Partial Complete

0 1 2

K.SYMETRICAL TONIC NECK REFLEX

Absent Present
0 1

10.Seizures

Absent Present
0 1

11.To asses sleep -Total sleep in 24 hours

<20 HRS 20-22 HRS 22-24 HRS
1 2 3

12.wakefulness
>1HR 1-2 HRS >2 HRS

1 2 3

B) Methods of assessment of objective pararmeters-

 Sr.Triglyceride(before and after treatment)
5.2 Methods and timing for assessing, recording, and analyzing of
efficacy parameters.

daily follow-up

Day of 1 2 3 4 5 6 7 8 9
life
Wt [kg]
R.R
H.R.
SPO2
TEMP
FEEDIN
G
URINE
MOTION
 Day of life 10th 15th 30th 45th 60th 90th 120th

Weight[kg]

HEAD
CIRCUMFERENCE
CHEST
CIRCUMFERENCE
LENGTH [CM]

FEEDING

REFLEX

MOROS

ROOTING

SUCKING

PALMER

PLANTER

EYE CONTACT

HEAD HOLDING

ASTR

SOCIAL SMILE

NECK HOLDING

TURNING OVER

STR

SEIZURES

SLEEP/24HRS

WAKEFULLNESS
MONITORING CHART-

DAY OF 10TH 15TH 30TH 45TH 60TH 90TH 120TH

LIFE
R.R.

H.R.

TEMP

SPO2

URINE

MOTION
LAKSHANA DUSHYA DOSHA FOLLOWUP

Reflexes BT 10TH 15TH 30TH

MOROS Mans,snayu,seera, VATA

kandara,asthi,maj
ja
KAPHA
ROOTING Mansa,meda,seera VATA
,snayu,majja

KAPHA
SUCKING Mansa,meda,majj VATA
a
KAPHA
PALMER Asthi,majja,snayu VATA
,kandara,mansa,m
eda KAPHA
PLANTER Asthi,majja,snayu VATA
,kandara,meda,m
ansa KAPHA
EYE CONTACT Mansa ,meda VATA

KAPHA
HEAD HOLDING Asthi,majja,snayu VATA
,kandara,meda,m
ansa KAPHA
ASTR Asthi,majja,snayu VATA
,kandara,meda,m
ansa KAPHA
SOCIAL SMILE Mansa medamajja VATA

KAPHA
TURNING OVER Asthi,mansa,majj VATA
a,snayu,meda
KAPHA
SEIZURES Asthi,majja,snayu VATA
,kandara,med,ma
nsa KAPHA
SLEEP/24HRS VATA

KAPHA
WAKE FULLNESS VATA

KAPHA
LAKSHANA DUSHYA DOSHA FOLLOWUP
BT 45TH 60TH 90TH 120T
REFLEXES H

MOROS Mans,snayu,seera, VATA

kandara,asthi,maj
ja
KAPHA
ROOTING Mansa,meda,seera VATA
,snayu,majja

KAPHA
SUCKING Mansa,meda,majj VATA
a
KAPHA
PALMER Asthi,majja,snayu VATA
,kandara,mansa,
meda KAPHA
PLANTER Asthi,majja,snayu VATA
,kandara,meda,m
ansa KAPHA
EYE CONTACT Mansa ,meda VATA

KAPHA
HEAD HOLDING Asthi,majja,snayu VATA
,kandara,meda,m
ansa KAPHA
ASTR Asthi,majja,snayu VATA
,kandara,meda,m
ansa KAPHA
SOCIAL SMILE Mansa medamajja VATA

KAPHA
TURNING OVER Asthi,mansa,majj VATA
a,snayu,meda,kan
dara KAPHA
SEIZURES Asthi,majja,snayu VATA
,kandara,med,ma
nsa KAPHA
SLEEP/24HRS VATA

KAPHA
WAKEFULLNESS VATA

KAPHA

Follow up of the patients will be observed by subjective and objective

parameters as mentioned above .Sr.triglyceride will be done before ad after
treatment.
6. Assessment of safety of trial subjects/research participants

6.1Specification of safety parameters.

The procedure that is abhyanga of babies will be conducted in draft free room
.Warm oil after being prechecked by the vaidya will be used for procedure .The
babies will be monitored for SPO2,respiratory rate, heart rate,tempereture.The
procedure will be done by the vaidya herself .

6.2The methods and timing for assessing, recording, and analyzing safety
parameters.

While conducting the abhyanga the baby’s parameters such as respiratory

rate,heart rate, SPO2,temperature will be monitored.

6.3Procedures for eliciting report of and for recording and reporting

adverse event.

The trial drug Dhanvantar oil does not have any adverse effect, if some
complications are seen such as increase in heart rate and respiratory rate ,falls
down in SPO2 then the procedure will be stop immediately and baby will be
admitted in the NICU and treated .In babies who are receiving abhyanga at
home will contact the hospital or principal investigator if complication arise.
These babies also will be treated in the hospital accordingly.

6.4The type and duration of the follow-up of subjects after adverse events.

Babies involving any untoward and unexpected adverse effect of the

treatment would be discontinued from the study, the cases would be
recorded separately and necessary action will be taken to overcome the
adverse effects as and when required.
If adverse event is seen in the baby then regular follow up every 7 days will
be done .

7.Risk and Benefits

7.1What are the potential risks to the subject?

The drug is not toxic and hence there is no potential risk to patients.
Care will be taken before during and after procedures to prevent any
complications the baby.Prewarmed oil after being checked by vaidya will be
used for the abhyanga .The vaidya herself will conduct the procedure hence,
eliminating potential risk to the baby.
7.2What are the compensations for unexpected risks?
If any unexpected risks occur during the trial as an outcome of research
process the treatment will be reduced or stop. Patient will be dropped from
study and approved treatment protocol necessary at that stage will be provided
to patient. Cost of treatment will be borne by the principle investigator.

7.3What are the potential benefits to the participating subjects?

A potential benefit to the participating subjects are achievement of age
appropriate growth and development.

8.Safety and other controls

Does this study involve ionizing radiation, hazardous substances, or hazardous

or invasive procedures (including radiological imaging, venipuncture or
intimate physical examination like proctoscopy, pv etc. )? YES /NO

:-NO

9.Consent:

Provide a copy of your consent form and information sheet. Write the procedure
about the following :

9.1 How will consent be obtained from subjects?

The informed consent in written will be given to the subjects parents for
reading. They may ask the queries about study, their role, risk, benefits etc.
After satisfaction and agreement, they will be included in the study

9.2How will it be made clear that subjects are under no compulsion to

participateand may withdraw at any time without jeopardizing any service
delivery or their relationship with the researcher?

It will be made clear verbally as well as in written that there is no compulsion

to participate in study and may withdraw any time without any damage to
relationship in between.
9.3 What data will be collected on those who refuse consent?

It will be made clear verbally as well as in written that those patients who drop
out during the course has been excluded and the patients who refuse consent
or not willing for consent are also excluded from the study.

10. Confidentiality

The subjects, who want their personal and disease information to be kept
confidential, will be identified by numbers 1, 2, 3 etc. (Coding).
The name of subjects will not be mentioned in report and any
publications produced from the study.
Subjects have the right to ask the study doctor to allow to see their
personal information and to have any needed corrections to it made.

11. Signatures of responsible investigators

Principal Investigator

Head of department

Collaborator
Designation & Organization

Ethics Committee Chair Head of Institute

 CASE PROFORMA

“STUDY THE EFFICACY OF DHANVANTARA TAIL AS ABHYANGA IN

PROMOTING NORMAL GROWTH AND DEVELOPMENT IN
PREMATURE INFANTS”

BHARTI VIDYAPETH AYURVED HOSPITAL,PUNE-43.

Name of Vaidya:

Name of group:

Name of patient:

Age : Sex: weight:

Mother’s investigation in pregnancy

HIB: Blood Group: BSL:

HIV: HBsAg: VDRL:

USG:

Maternal Risk Factors:

Register /Non Register:

H/O Maternal illness\medical history\medicine history

Mother examinations:

Temp : Pulse: B.P. :

R.S. P/A

C.V.S. URINE:

C.N.S. MOTION:

BREAST\STANYA PARIKSHAN:

CHIEF COMPLAINTS
H/O present illness

G.A.by: LMP: Weeks: Days:

G.A. by USG: Weeks: Days:

G.A. by New Ballard’s Score:

Average:

Birth weight:

Congenital disorders:

Type of delivery:

1. Type:
2. Anesthesia:
3. Medication:
4. Fetal monitoring:
5. H/O meconium or leak
Birth History:

APGAR 1Minute 5Minute

CRY Spontaneous

Assisted A) Bag and Mask: B) Intubation:

Family History

1. Parity
2. Abortions
3. Neonatal Deaths
4. Family Medical /Heridatory problems.
Social History:

Mother: Age: Work:

Father: Age: Work:

Marriage: consangious /non consangious

SARVADEHIK PARIKSHAN

Activity: Head circumference in cm :

Cry: Chest circumference in cm :

Length in cm:

Temperature:

HR: RR:

A.F: P.F:

R.S:

C.V.S:

C.N.S:

P/A:
Urine : Motion:

Twacha: Maldwara:

Nakha: Mutradwar:

Kesha: Yonidwar:

Jivha: Shwasan:

Nabhi: Rodan: Nidra:

INDRIYA PARIKSHAN:

1. Shravanindriya: Karna:

2. Sparshanindriya: Twacha:

3. Chakshurindriya: Netra:

4. Rasnaindriya: Jivha:

5.Ghranaindriya: Nasa:
KARMENDRIYA:

1. Vak Jivha
2. Pani Hasta
3. Pada Pada
4. Payu Guda
5. Upastha Linga
6. Prakrutiparikshanvinischaya

STROTAS PARIKSHAN: BT AT

pranavaha :- Nasa

Kantha

Phupusa

Hrudaya

Shwasmarga

Annavaha :- Mukha

Danta

Jivha

Amashaya

Grahani

Agni

Koshta

Rasavaha :- Ashraddha

Aruchi

Tandra
 BT AT

Purishavaha: krichhata

Atibaddhaatidrava

Sashula

Sashabda

Udakvaha :- Jivha

Talu

Raktavaha : -Yakrut

Pleeha

Mukha

Nakha

Raktavahini

Mansavaha: - Akruti

Samahnan

Dehabhar

Snayu

Twacha

Medovaha :- Vrikka

Udarkati
 BT AT

Sphik

Asthivaha :- Asthi

Danta

Kesh

Nakha

Majjavaha :- Netra

Sandhi

Swedavaha :-

Mutravaha :-

Manovaha :-

NIDAN PANCHAK

Hetu

Purvaroopa

Roopa
Upshaya

Samprapti

OBSERVATION TABLE:

daily follow-up

Day of life 1 2 3 4 5 6 7 8 9
Wt [kg]
R.R
H.R.
SPO2
TEMP
FEEDIN
G
URINE
MOTION
 Day of life 10th 15th 30th 45th 60th 90th 120th

Weight[kg]

HEAD
CIRCUMFERENCE
CHEST
CIRCUMFERENCE
LENGTH [CM]

FEEDING

REFLEX

MOROS

ROOTING

SUCKING

PALMER

PLANTER

EYE CONTACT

ASTR

SOCIAL SMILE

NECK HOLDING

TURNING OVER

STR

SEIZURES

SLEEP/24HRS

WAKEFULLNESS
MONITORING CHART-

DAY OF 10TH 15TH 30TH 45TH 60TH 90TH 120TH

LIFE
R.R.

H.R.

TEMP

SPO2

URINE

MOTION
LAKSHANA DUSHYA DOSHA FOLLOWUP

REFLEX BT 10TH 15TH 30TH

MOROS Mans,snayu,seera,kan VATA

dara,asthi,majja

KAPHA
ROOTING Mansa,meda,seera,sn VATA
ayu,majja

KAPHA
SUCKING Mansa,meda,majja VATA

KAPHA
PALMER Asthi,majja,snayu,ka VATA
ndara,mansa,meda
KAPHA
PLANTER Asthi,majja,snayu,ka VATA
ndara,meda,mansa
KAPHA
EYE CONTACT Mansa ,meda VATA

KAPHA
HEAD HOLDING Asthi,majja,snayu,ka VATA
ndara,meda,mansa
KAPHA
ASTR Asthi,majja,snayu,ka VATA
ndara,meda,mansa
KAPHA
SOCIAL SMILE Mansa medamajja VATA

KAPHA
TURNING OVER Asthi,mansa,majja,sn VATA
ayu,meda,kandhara
KAPHA
SEIZURES Asthi,majja,snayu,ka VATA
ndara,med,mansa
KAPHA
SLEEP/24HRS VATA

KAPHA
WAKE FULLNESS VATA

KAPHA
LAKSHANA DUSHYA DOSHA FOLLOWUP

REFLEX BT 45TH 60TH 90TH 120TH

MOROS Mans,snayu,seera,kan VATA

dara,asthi,majja

KAPHA
ROOTING Mansa,meda,seera,sn VATA
ayu,majja

KAPHA
SUCKING Mansa,meda,majja VATA

KAPHA
PALMER Asthi,majja,snayu,ka VATA
ndara,mansa,meda
KAPHA
PLANTER Asthi,majja,snayu,ka VATA
ndara,meda,mansa
KAPHA
EYE CONTACT Mansa ,meda VATA

KAPHA
HEAD HOLDING Asthi,majja,snayu,ka VATA
ndara,meda,mansa
KAPHA
ASTR Asthi,majja,snayu,ka VATA
ndara,meda,mansa
KAPHA
SOCIAL SMILE Mansa medamajja VATA

KAPHA
TURNING OVER Asthi,mansa,majja,sn VATA
ayu,meda,kandara
KAPHA
SEIZURES Asthi,majja,snayu,ka VATA
ndara,med,mansa
KAPHA
SLEEP/24HRS VATA

KAPHA
WAKEFULLNESS VATA

KAPHA
Differential diagnosis

Diagnosis

Treatment and management

COLLEGE OF AYURVEDA
 BHARATI VIDYAPEETH UNIVERSITY
KATRAJ – DHANKAWADI
PUNE – 411O43
INFORMED CONSENT

I’m baby’sMother/father,Mr/Miss/Mrs.....................................................................Age.........years
will fully given the concent to Dr,BharatiMalhari Hake .To include our baby in a clinical trial
Titled“Study the efficacy of dhanvantar tail as abhyanga in promoting normal growth and
development in premature infants”
.I am ready to allow the Vaidya to all the treatment ;Investigation and dhanvantartailaAbhyanga
on our baby to study its effects.theVaidya fully described me all possible effects of dhanvantar
tail Abhyanga on babyand I have given my consent in complete consciousness and without under
any pressure.

Name of mother/father : Name of Doctor

Date
:
Sign/Thumb

place

संमतीपत्र
मीसौ / श्री ............................................येथेराहणार / राहणारीलिहूनदेतो /
देतेकिमाझ्याबाळाला.“AkxaÊp`asautabaaÊk|
MmaQËoQaanvaMtartaOlaAaiNaKaaobarolataOÊcaI
{payau@tataa”प्रयोगयाशोधप्रकल्पामध्येस्वेच्छे नेअंतर्भूतकरतआहे.
हेशोधकार्यभारतीविद्यापीठाच्याआयुर्वेदरुग्णालयपुणेयेथेहोणारआहे.
यासंमतीपत्रातीलसर्वमजकू रमलासमजेलअशाभाषेतसमजावूनसांगण्यातआलेलाआहे.यापद्धतीमध्येसंभाव्
यधोक्यांचीमलासंपूर्णजाणीवआहे .तसेचलागणारीसर्वतपासणीवउपचारासाठीमाझीसंमतीआहे.

1) मलाकल्पनाआहेकिडॉक्टरमाझ्याबाळाचीतपासणीकरतील
2) डॉक्टरांनीदिलेल्यासर्वसुचनांचेतंतोतंतपालनकरणारतसेचलागणाऱ्यासर्वतपासण्यावउपचारासाठी
माझीसंमतीआहे.
3) भारतीविद्यापीठाच्याआयुर्वेदरुग्णालयातीलडॉक्टरमाझ्याबाळावरउपचारकरतीलवत्यासमाझीका
हीहीहरकतनाही
4) याशोधकार्यातूनमिळालेलीमाहितीसम्पुर्णपणेगुप्तठे वलीजाईलवत्याचावापरफक्तशोधकार्यापुरता
चके लाजाईलयाचीमलाकल्पनाआहे.खालीसहीकरणारीव्यक्तीडॉक्टरयांनीशोधकार्याविषयीसंपूर्णच
र्चाके लीआहे. वमाझ्यासर्वशंकांचेनिरसनके लेआहे.

सदरपत्रकमीपूर्णपणेवाचलेलेवसमजावूनघेतलेलेआहेमलायाशोधकार्याविषयीपूर्णकल्पनामिळालीअसूनमी
त्यातस्वइच्छे नेमाझ्याबाळालासामीलकरतआहेतसेचपत्रकातीलसर्वरिकाम्याजागामाझ्यादेखतवमीसहीक
रण्यापूर्वीभरल्याआहेत.तरीमीयाशोधकार्यातस्वइच्छे नेसामीलहोतआहे.
संमतीपत्रावरस्वताचीस्वाक्षरीकरूनत्याचीप्रतदेतआहे.

ठिकाण

दिनांक

डॉक्टरनाव रूग्णाचेआई / वडील नाव सही / अंगठा

 Appendix 2

Undertaking by the Investigator

01. This research project (including collection of blood or tissues samples for
research) willnot be started until the final approval of the BVDUCOA-EC
has been obtained.
02. We agree to undertake research proposal involving human subjects in
accordance withthe ICH-GCP and ICMR ethical guidelines, 2006 till the
draft guidelines for ASU drugs {rule 170, schedule Z} are confirmed. We
will not modify the research protocol,consent, etc. without prior approval
by the BVDUCOA-EC.
03. The investigators agree to obtain a properly informed and understood
consent for alltrial subjects before their inclusion in the trial in the
informed consent form that isapproved by the BVDUCOA-EC.
Participants will receive an ‘information sheet’ which will detailthe project
design in simple understandable layperson’s language.
04. The investigators agree to report within a week all serious adverse events
(SAE) associatedwith the trial in the SAE form to the BVDUCOA-EC. In
the event of a death of the trial subject, theSecretary, BVDUCOA-EC and
SRC, will be informed within 24 hours.
05. The investigators agree to submit periodic 6 monthly progress report of
the trial in the appropriate form. A final report will be submitted at the
end of the trial.
06. Full details on funding and a proposed budget are included with the trial
proposal. The proposed budget is presented on the specific budget sheet
07. We understand that the BVDUCOA-EC is concerned about transparent
financial transactions during the trial. A report on how the trial funds
were utilized will be presented to the EC along with the final project
report at the end of the trial.
08. For all research proposals that are sponsored by a pharmaceutical or
biomedical company,we the investigators will ensure that the Sponsor
Company will underwrite all expensessuch that neither the hospital nor
the study participants are made to spend whileparticipating in the trial.
The investigators will also ensure that in the event of
complicationsarising directly due to the trial or litigation, the cost of
management or legal fees will beborne by the Sponsor Company totally.
09. The investigators state that they do not stand to gain financially from the
commercialsponsor and don’t have conflict of interest in the drug or
product by way of consultations,shareholding, etc.
10. The investigators will ensure that personnel performing this study are
qualified, appropriatelytrained and will adhere to the provisions of the
BVDUCOA -EC, approvedprotocol.
11. All data collected during the research project, including those supported
by commercialsponsors (e.g. pharmaceutical company), will remain the
property of BVDU COA.
12. The salaries to staff employed for the research project will be as shown in
the budget sheet and in accordance with the provisions made by the
funding agencies.
13. The case records (source documents) will be made available to members
of the SRC orBVDUCOA-EC any time for random verification and
monitoring. The case records (sourcedocuments) will be preserved in the
premises of BVDUCOA for at least 5 years after the lastapproval of
application or publication.
14. The investigators promise to ensure that there is no falsification of data
when compared to the source documents. We agree to clarify any doubts
or discrepancies that may ariseduring the data monitoring evaluation.
15. All the findings and conclusions of the proposed project such as review of
case records,analysis of forms of treatment, investigations, etc will be
first presented to the staff members of BVDUCOA before they are
released or presented elsewhere. The investigators will submit a copy of
the abstract to the SRC and BVDUCOA-EC well in advance of any
proposed presentation at national or international conferences or
seminars.
16. The investigators will not issue any press release before the data and
conclusions have been peer-reviewed by the BVDUCOA staff or published
in a peer-reviewed journal.
17. All serious injuries arising from the trial will be the responsibility of the
investigators.The investigators agree to ensure that the sponsors
undertake a product liability insuranceto cover any expenses for injury
or compensation arising from the study treatment.
18. The investigators agree to transfer 15% of the total budget to BVDUCOA
as service charges. This will not apply to intramural projects, those co-
sponsored by BVDU college of Ayurveda and collaborative projects with
BVDU COA
19. The investigators agree that the grant money will be spent in accordance
with the budget proposal only. The funds will not be used for any other
 purposes without prior approval from the BVDUCOA-EC. Thirty percent
of the surplus grant if left over at the end of the study will be credited to
BVDUCOAThe remaining 70% of the surplus grant money may be used
by the investigators for conducting intramural research, improving
teaching facilities in the department, providing financial assistance to
investigators for conferences, etc after obtaining permission from the
BVDUCOA-EC. In case of government grants, the unspent balance will
be spent/ returned as per the directives given along with the project
sanction letter.
20. The investigators will constantly inform the BVDUCOA-EC about
amendments in the study protocol,data collection forms, informed
consent forms, budget expenses, salaries, other trialdocuments, etc. as
and when they occur. No major changes in the treatment arms or
thestudy protocol or randomization technique will be carried out without
prior permissionof the BVDUCOA-EC.
21. The investigators willcomply with all policies and guidelines of the
BVDUCOA and affiliating/collaborating institutionswhere this study will
be conducted, as well as with all applicable laws regarding theresearch.

We the investigators of the proposed trial have read all the statements
listed above andagree to observe / undertake these BVDUCOA-EC
requirements while conducting our proposedproject / trial.

Sign of PI

Sign of Co-I

Sign of Co-2

Date

Seal