| CTRI Number |
CTRI/2025/12/098916 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Clinical Trial on Weaning Food. |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Trial To Evaluate The Effect of Ragi-Rice and Ragi- Wheat Compounds as a Weaning Food on Infants Nutritional and Health Status |
| 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 Manaswitha Jain |
| Designation |
PG Scholar Kaumarabhritya |
| Affiliation |
Sdm Ayurveda College , Hospital and Research Centre Kuthpady Udupi |
| Address |
Opd 11, Department of Kaumarabhritya, Shri Dharmasthala Manjunateshwara College of Ayureda Hospital and Research Centre Kuthpady Udupi.
Udupi
KARNATAKA
574118
India |
| Phone |
9036091197 |
| Fax |
|
| Email |
drmanaswithajain997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagaratna S Jartarghar |
| Designation |
Associate Professor Kaumarabhritya |
| Affiliation |
Sdm Ayurveda College , Hospital and Research Centre Kuthpady Udupi |
| Address |
Opd 11, Department of Kaumarabhritya, Shri Dharmasthala Manjunateshwara College of Ayureda Hospital and Research Centre Kuthpady Udupi.
Udupi
KARNATAKA
574118
India |
| Phone |
8971518695 |
| Fax |
|
| Email |
nagaratnar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nagaratna S Jartarghar |
| Designation |
Associate Professor Kaumarabhritya |
| Affiliation |
Sdm Ayurveda College , Hospital and Research Centre Kuthpady Udupi |
| Address |
Opd 11, Department of Kaumarabhritya, Shri Dharmasthala Manjunateshwara College of Ayureda Hospital and Research Centre Kuthpady Udupi.
KARNATAKA
574118
India |
| Phone |
8971518695 |
| Fax |
|
| Email |
nagaratnar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Shree Dharmasthala Manjunateshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi 574118 , Kaumarabhritya OPD - 11
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [(Nil)] |
|
|
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 Manaswitha Jain |
Shri Dharmasthala Manjunateshwara Ayurveda Hospital Kuthpady Udupi 574118 |
Opd 11, Department of Kaumarabhritya ,Shri Dharmasthala Manjunateshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi. 574118
Karnataka
Udupi
KARNATAKA |
9036091197
-
drmanaswithajain997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee - Human |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Infants |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ragi-Wheat Compound, Reference: Folk Medicine, Route: Oral, Dosage Form: Modaka , Dose: 10(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 60 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: Ragi - Wheat Compounds are given in the form of porridge by mother to infants. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ragi - Rice Compound, Reference: Folk Medicine , Route: Oral, Dosage Form: Modaka , Dose: 10(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 60 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: Ragi- Rice Compounds are made in the form of porridge by the mother and given to infants |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
9.00 Month(s) |
| Gender |
Both |
| Details |
1.Infants of either gender between the age of 6 months - 9 months in whom weaning has not been started yet are included in the study.
2.Clinically stable infants. |
|
| ExclusionCriteria |
| Details |
1.Infants having severe Malnutrition like Protein Energy Malnutrition (PEM), Marasmus etc.
2.Infants with inborn error of metabolism.
3.Infants having CNS disorders like Cerebral Palsy, Mental Retardation, Congenital diseases.
4.Infants with chronic system ailments which requires medications.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This Clinical Trial is expected to evaluate the comparative effect of Ragi- Rice and Ragi - Wheat Compounds as a weaning food on nutritional and health status of infants |
This Clinical Trial of Ragi - Rice and Ragi - Wheat Compounds carried out for 2 months will intend to evaluate the comparative effect of both the compounds as weaning food on nutritional and health status of infants |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ragi - Rice Compounds as Weaning Food may be more effective on Infants Nutritional and Health Status when compared to Ragi - Wheat Compounds. |
2 Months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
23/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/12/2025 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Folk medicine is widely available and affordable even in
remote areas and generally accessible to most people Child health care being
one of the major area in the traditional medicine practice and has been using
many traditional preparations as a weaning food One such traditional
preparation is making of compound in the form of disc by using the milk extract
of Ragi and Wheat later made into a dried disc that can be stored for long time
and served with cows milk jaggery and ghee when made into porridge form The
techniques enhance the bio availability of micronutrients and by improving
overall absorption of nutrients Small effort to reach all these requirements is
made in the present study to evaluate the effect of Ragi-Rice compound over
Ragi Wheat compound to the infants of age 6 to 9 months as weaning food on
infants nutritional and health status |