| CTRI Number |
CTRI/2019/06/019922 [Registered on: 27/06/2019] Trial Registered Prospectively |
| Last Modified On: |
21/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Purification of breast milk through Ayurveda |
|
Scientific Title of Study
|
Randomised Clinical trial to assess the efficacy of Devdarvyadi kashaya in mother and Saraladi Avaleha in breastfeeding infant to improve weight gain in underweight infant |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ganesh Kumar |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 112
Parul Ayurved Hospital
Kaumarbhritya OPD No 112
Parul Ayurved Hospital
Vadodara
GUJARAT
391760
India |
| Phone |
8803093191 |
| Fax |
|
| Email |
ganeshkr72@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayank Maniar |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Parul Ayurved Hospital
Parul university
OPD no 112
PO Limda Tal Waghodia Distt Vadodara gujarat 391760
Parul university
PO Limda Tal Waghodia Distt Vadodara gujarat 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9429805545 |
| Fax |
|
| Email |
mayank2200@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Kumar |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 112
Parul Ayurved Hospital
Parul university
Room no 206
Kaumarbhritya Department
Parul Institute of Ayurved
Parul university
Vadodara
GUJARAT
391760
India |
| Phone |
8803093191 |
| Fax |
|
| Email |
ganeshkr72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved
Parul University
PO Limda Tal Waghodia
district Vadodara Gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurved
Parul university
PO Limda Tal Waghodia Distt Vadodara gujarat 391760 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ganesh Kumar |
Parul Institute of Ayurved |
PO Limda Tal Waghodia Distt Vadodara
Vadodara
GUJARAT |
8803093191
ganeshkr72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIA-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E441||Mild protein-calorie malnutrition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Devdarvyadi kashaya and Saraladi avleha |
Devdarvyadi kashaya to mother in dose of 96 ml and Saraladi avleha to infant in dose of 3-5 ml |
| Intervention |
Protein, Carbohydrate, Fat, Energy estimation of Breast milk
weight Assessment of child |
these are to be done before and after completion of trial |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
8.00 Month(s) |
| Gender |
Both |
| Details |
Age>2 months and <8 months
Weight less than expected for age between normal to minus 2 Standard deviation |
|
| ExclusionCriteria |
| Details |
VLBW Babies, Premature Babies
Babies taking top feeding other than breast mlk
child with genetic abnormality and systemic illness
child with eventful birth history like convulsion and birth asphyxia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| weight gain in infant |
one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to improve quality of breastmilk |
one and half month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
22/07/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A trial is done to check the efficacy of devdarvyadi kashaya and Saraladi avleha. |