| CTRI Number |
CTRI/2025/04/085672 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluating the Efficacy of Tiladi Modak and Bajradi Modak for Managing Undernutrition in Children |
|
Scientific Title of Study
|
COMPARATIVE STUDY ON TILADI MODAK AND BAJRADI MODAK IN THE
MANAGEMENT OF KARSHYA (UNDERNUTRITION) AS WEIGHT PROMOTOR IN CHILDREN-TWO ARM OPEN LABEL TRIAL |
| 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 Sangeeta Kumari |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute of Ayurveda Jodhpur |
| Address |
PG Department of Kaumarbhritya Post Graduate Institute of Ayurved
DSRRAU Jodhpur Nagaur Road Kadwad Jodhpur Rajasthan
RAJASTHAN India
342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8619662484 |
| Fax |
|
| Email |
sangeetabhomikkumari2022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Harish Kumar Singhal |
| Designation |
Professor & HOD |
| Affiliation |
Post Graduate Institute of Ayurveda Jodhpur |
| Address |
Room no 155 PG Department of Kaumarbhritya Post Graduate
Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan
Ayurved University Campus Kadvad Jodhpur Rajasthan India 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636622206 |
| Fax |
|
| Email |
ayurharish14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Harish Kumar Singhal |
| Designation |
Professor & HOD |
| Affiliation |
Post Graduate Institute of Ayurveda Jodhpur |
| Address |
Room no 155 PG Department of Kaumarbhritya Post Graduate
Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan
Ayurved University Campus Kadvad Jodhpur Rajasthan India 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636622206 |
| Fax |
|
| Email |
ayurharish14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur 342037 Rajasthan India |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
| Address |
PG Department of Kaumarbhritya Post Graduate Institute of
Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Kadvad Jodhpur Rajasthan India Jodhpur
RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Type of Sponsor |
Government 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 |
| DrSangeeta Kumari |
post graduate institute of ayurveda DSRRAU jodhpur |
PG Department of Kaumarbhritya Post Graduate Institute of Ayurved DSRRAU Jodhpur Nagaur Road Kadwad Jodhpur Rajasthan Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN |
8619662484
sangeetabhomikkumari2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Post Graduate Institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E46||Unspecified protein-calorie malnutrition. Ayurveda Condition: KARSYAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Bajaradi Modak, Reference: NA, Route: Oral, Dosage Form: Modaka, Dose: 60(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tiladi Modak, Reference: Gad Nigraha Volume 2 Chapter 9/66, Route: Oral, Dosage Form: Modaka , Dose: 60(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
a. Children age group from 1-16 years of both sexes having clinical signs &
symptoms of Undernutrition described in Ayurveda classics & modern
literature.
b. Patients having weight less than ideal weight for age. |
|
| ExclusionCriteria |
| Details |
a. Children below1 year & above16 years of age.
b. Known cases of systemic disorders like tuberculosis, HIV, Hepatitis, and
Carcinoma.
c. Known case of any endocrinal disorder like hyperthyroidism, or food allergy.
d. Known case of inborn error of metabolism (IEM). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Tiladi Modak & Bajradi Modak in the management of Karshya (Undernutrition) as weight promoter. |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Tiladi Modak & Bajradi Modak will be found effective in increasing over all growth of
children.
2. Nutritional profile of both Tiladi Modak & Bajradi Modak is calculated in the Lab. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
a two arm open labeled clinical trail group A Number of Patients - 45 Number of Patients - Open label two arm Drug on trial- Tiladi Modak Dose - Will be given in the form of
Modak as per Young`s
Formula Anupana - Luke warm water/milk Route - Oral route Follow up - Follow up after every 10th day
during the study and 45 days
after completion of the study.
group B Number of Patients - 45 Number of Patients - Open label two arm Drug on trial-Bajradi modak Dose - Will be given in the form of Modak as per Young`s Formula Anupana - Luke warm water/milk Route - Oral route Follow up - Follow up after every 10th day during the study and 45 days after completion of the study. |