| CTRI Number |
CTRI/2019/04/018470 [Registered on: 08/04/2019] Trial Registered Prospectively |
| Last Modified On: |
05/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Shiva modak granules in the management of under nutrition children |
|
Scientific Title of Study
|
A randomised controlled clinical trial to evaluate the efficacy of shiva modak granules in the management of karshya in children w.s.r to undernutrition |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dipak Prakash Chaudhari |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Opd No 112 Parul Ayurved Hospital Parul institute of Ayurved Parul University Limda tal Waghodia Dist Vadodara,
Vadodara
GUJARAT
391760
India |
| Phone |
9970048306 |
| Fax |
|
| Email |
drdpc15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr Rajanish Meti |
| Designation |
professor |
| Affiliation |
Parul institute of Ayurved |
| Address |
Opd No 112 Parul Ayurved Hospital Parul institute of Ayurved Parul University Limda tal Waghodia Dist Vadodara,
Vadodara
GUJARAT
391760
India |
| Phone |
9986660145 |
| Fax |
|
| Email |
rajanishsm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dipak Prakash Chaudhari |
| Designation |
PG Scholar |
| Affiliation |
Parul institute of Ayurved |
| Address |
Opd No 112 Parul Ayurved Hospital Parul institute of Ayurved Parul University Limda tal Waghodia Dist Vadodara,
Bharuch
GUJARAT
391760
India |
| Phone |
7020831099 |
| Fax |
|
| Email |
drdpc15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Children attending OPD & IPD of Parul Ayurved Hospital various camps organized by the Department of Kaumarabritya and from Anganwadi or school health checkups will be enrolled in the clinical trial |
|
|
Primary Sponsor
|
| Name |
Department of Kaumarbhritya |
| Address |
Parul Institute of Ayurved, Parul University limda Tal Waghodian Dist vadodara |
| 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 |
| Dipak Prakash Chaudhari |
Parul Institute of Ayurved |
Opd No 112 parul ayurved hospital limda Tal Waghodia Dist Vadodara
Vadodara
GUJARAT |
9970048306
drdpc15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ithical committee parul institute of ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E46||Unspecified protein-calorie malnutrition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyderabad mix |
The nutritive value of 200 gm of mixture provides 768 k cal of energy and 27.2 gm of protein for 1 week. This mixture given daily once in the dose of 30 gm per day For 8 weeks
route- oral |
| Intervention |
shiva modak granules |
Shiva Modak granules on empty stomach in morning followed by Hyderabad mix to be prepared in milk for 8 weeks.
Route- oral
dose-
3 to 4 year-3 grams(3masha)
4 to 5 year-4 grams (4masha)
5 to 6 year-5 grams (5masha)
6 year-6 grams (6masha) |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
subject with in age group 3 year to 6 year will be included in the study irrespective of sex,caste and religion.
subject with weight up to -2SD for the expected weight for age. |
|
| ExclusionCriteria |
| Details |
chronic malnutrition,
secondary malnutrition,
congenital disease,inborn errors of metabolism, kwashiorkor or any other systemic illness with organic causes,
LBW babies whose catch up growth is not attend.
|
|
|
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 |
| Improvement in the nutritional status in children taking Hyderabad mix along with Shiva Modak granules. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in general well being of children taking Hyderabad mix along with Shiva Modak granules |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/04/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
brief summary- This study has been design to study the efficacy of this drug in the management of children in under nutrition . A shivamodak granule is palatable form of shiva modak. And the Hyderabad mix which is a cheap ad easily available dietary supplement proved to enhance growth and development in the process of nutritional rehabilitation. background of trial - In this study there are two groups in which group (A) the patient in the study will be given shivamodak granule on empty stomach in the morning follow by
Hyderabad mix to be prepared in milk for 8 weeks. Now group (B) the patient in the control group will be given only Hyderabad mix to be prepared in milk for 8 weeks. and then assessment of the patient in both of the group will be assessed on the first day and subsequently in the interval of four week during the study and follow up for four weeks two week interval up to 12 weeks .
shivmodak granule is effective in the management of under nutrition in children along with Hyderabad mix |