| CTRI Number |
CTRI/2020/01/022686 [Registered on: 10/01/2020] Trial Registered Prospectively |
| Last Modified On: |
15/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Ashwagandhadi Avaleha in treatment of under weight children |
|
Scientific Title of Study
|
A Randomized controlled clinical study to evaluate the efficacy of Ashwagandhadi Avaleha in the management of of Karshya with special reference to underweight children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lakshmi Devi Chauhan |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
1st Floor Room No-204,Department of Kaumarbhritya, Parul Institute of Ayurved, Parul University, Post limda, Tal Waghodia,Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8265941585 |
| Fax |
|
| Email |
laxmichauhan826594@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajanish Meti |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
1st Floor Room No-204,Department of Kaumarbhritya, Parul Institute of Ayurved, Parul University, Post limda, Tal Waghodia,Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9986660145 |
| Fax |
|
| Email |
rajanishsm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajanish Meti |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
1st Floor Room No-204,Department of Kaumarbhritya, Parul Institute of Ayurved, Parul University, Post limda, Tal Waghodia,Vadodara
GUJARAT
391760
India |
| Phone |
9986660145 |
| Fax |
|
| Email |
rajanishsm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved, Parul University, Post limda, Tal Waghodia,Vadodara
 |
|
|
Primary Sponsor
|
| Name |
Department of Kaumarbhritya |
| Address |
Parul Institute of Ayurved, Parul University, post Limda, tal Waghodia, 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 |
| Dr Lakshmi Devi Chauhan |
Parul Ayurved Hospital |
Opd No 112, Kaumarbhritya, Parul Ayurved Hospital, Parul University, Post- limda, Teh- Waghodia, Vadodara
Vadodara
GUJARAT |
8265941585
laxmichauhan826594@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research |
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 |
| Intervention |
Ashwaganghadi Avaleha |
Dosage(Age group 5 to 7 years)- 15gm in two divided dose before food
Dosage(Age group 8 to 10 years)- 25gm in two divided dose before food
Route of Adminstration- Oral For 60 days |
| Comparator Agent |
Preenana Modaka |
Dosage(Age group 5 to 7 years)-15gm in two divided dose before food
Dosage(Age group 8 to 10 years)- 25gm in two divided dose before food
Route of Adminstration- Oral for 60 days
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects within age group 5 -10 years will be included in the study irrespective of sex,
caste & religion.
2 Subjects with weight up to -2 SD for the expected weight for age. |
|
| ExclusionCriteria |
| Details |
1 Chronic malnutrition.
2 Secondary malnutrition.
3 K/c/o Congenital Diseases, Inborn Errors of Metabolism, kwashiorkor or any other
systemic illness with organic causes. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ashwaghandhadi Avaleha is more than or as effective as Preenana Modaka in the management of Karshya in children |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of Preenana Modaka in the management of Karshya in children |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/01/2020 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1 The children are the most vulnerable members of the society in terms of health. The
present world is dealing with the problems of malnutrition in children specially in
developing countries like India. 2 Despite a fast-growing economy and the largest anti-malnutrition programme (ICDS,
Mid-day meal, Poshan Abhiyaan) India has the world’s worst level of child
malnutrition. The government plans to pump in Rs 12,35,580 crore over the next five
years to tackle the problem. (https://www.downtoearth.org.in/coverage/health) 3 The overall prevalence of underweight among under 5 five children was 43% (49.8%
male and 36.7% female). 4 The overall prevalence of stunting among under five children was 38% (40.1% male
and 35.9% female ) and significantly associated with gender.
6 5 Therefore, it is the need to develop various methods apart from modern suppliments
to aid this problem. |