| CTRI Number |
CTRI/2024/04/066169 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
20/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of ayurvedic medicated ghee on weight gain in children |
|
Scientific Title of Study
|
A Randomized Clinical Study To Determine The Effectiveness Of Ashwagandhaghrita As An Add On Supplements In The Management Of Karshyata In Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jivan Ashok Deshmukh |
| Designation |
PhD scholor |
| Affiliation |
Government Ayurved College Osmanabad |
| Address |
OPD no 37 Kaumarbhritya OPD
Osmanabad
MAHARASHTRA
413501
India |
| Phone |
9420025454 |
| Fax |
|
| Email |
jivan143d@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Bhikchand Kale |
| Designation |
Prefessor and Guide |
| Affiliation |
Government Ayurved College Osmanabad |
| Address |
OPD no 37 Kaumarbhritya OPD
Osmanabad
MAHARASHTRA
413501
India |
| Phone |
9284508076 |
| Fax |
|
| Email |
kaleanilb@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Bhikchand Kale |
| Designation |
Prefessor and Guide |
| Affiliation |
Government Ayurved College Osmanabad |
| Address |
OPD no 37 Kaumarbhritya OPD
MAHARASHTRA
413501
India |
| Phone |
9284508076 |
| Fax |
|
| Email |
kaleanilb@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College Osmanabad 413501 |
|
|
Primary Sponsor
|
| Name |
Dr Jivan Ashok Deshmukh |
| Address |
Government Ayurvedic College Osmanabad 413501 |
| Type of Sponsor |
Other [Self] |
|
|
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 Jivan Ashok Deshmukh |
Government Ayurvedic Hospital Osmanabad |
OPD no 37 Kaumarbhritya OPD
Osmanabad
MAHARASHTRA |
9420025454
jivan143d@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Govt Ayurvedic College Osmanabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E441||Mild protein-calorie malnutrition. Ayurveda Condition: KARSYAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashvagandha Ghruta, Reference: Chakradatta, Route: Oral, Dosage Form: Ghrita, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: -Alongwith Maharashtra Government Nutrition Protocol used in Child Development Centre at Anganwadi | | 2 | Comparator Arm (Non Ayurveda) | | - | Roasted whole wheat roasted Bengal gram Roasted groundnut and jaggery | Roasted whole wheat 40 gm, roasted Bengal gram 16 gm Roasted groundnut 10 gm and jaggery 20 gm once daily for 90 days |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children whose weight is above 60% and below 80% of expected weight according to IAP guidelines.
The children having clinical manifestations of Moderate Acute Malnutrition in Karshyata
|
|
| ExclusionCriteria |
| Details |
Children whose weight is above 80% and below 60% ofexpected weight for age.
Tuberculosis, Metabolic Disorders, Congenital Disorders, Malignancies, Mal absorption syndrome.
Malnutrition with complication.
Severe sick babies.
Patient apparent acute infection
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight gainin malnaurished children from the baseline |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in behavior, sleep, appearance, appetite |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
06/05/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ayurveda
gives prime importance to the nutrition at every stage of life for preserving
health of an individual. Proper nutrition is essential for rapid growth and
development which obtains through baby’s first year of life. Malnutrition in
India, as in other developing countries,
results
from a series of interrelated factors rooted in poverty, including lack of
access to food, health care, safe water, sanitation services, and appropriate
child feeding and caring practices. Under nutrition is a state of poor nutritional status as a result of
inadequate intake, mal absorption or excessive loss of nutrients. As these
children is future of community and if such conditioned is not overcome within
a stipulated timeframe, then it may result further in growth and ultimately it
directly affects the economy of a country also. In Ayurveda, there are some
formulations given in Chakradatta, Ashwagandhaghrita
is mentioned as balya and Dhatuwardhak. These formulations having energy value with protein rich content and
it is cost effective treatment for Karshyata.
In this study, Ashwagandhaghrita will be administrated among children
suffering from karshyata. |