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CTRI Number  CTRI/2024/03/063618 [Registered on: 05/03/2024] Trial Registered Prospectively
Last Modified On: 27/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to evaluate the effect of Baladi Granules in the management of karshya vyadhi (mild to moderate undernutrition) in children. 
Scientific Title of Study   A randomized controlled clinical study to evaluate add on effect of Baladi Granules in the management of karshya vyadhi (mild to moderate undernutrition) 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 Mosim Momin 
Designation  Associate Professor 
Affiliation  Dr D Y Patil College of Ayurveda and Research centre 
Address  OPD NO 1 DEPARTMENT OF KAUMARBHRITYA Dr D Y Patil College of Ayurveda and Research centre Postal address Sant Tukaram Nagar Pimpri Pune 4110 18 Telephone 020 27805899

Pune
MAHARASHTRA
411018
India 
Phone  7350751503  
Fax    
Email  dr.mosim2010@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepak Khawale 
Designation  Prof and HOD, Department of Kaumarbhritya 
Affiliation  Dr D Y Patil College of Ayurveda and Research centre 
Address  OPD NO 1 DEPARTMENT OF KAUMARBHRITYA Dr D Y Patil College of Ayurveda and Research centre Postal address Sant Tukaram Nagar Pimpri Pune 4110 18 Telephone 020 27805899

Pune
MAHARASHTRA
4110 18
India 
Phone  9923220055  
Fax    
Email  drdeepak77@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Khawale 
Designation  Prof and HOD, Department of Kaumarbhritya 
Affiliation  Dr D Y Patil College of Ayurveda and Research centre 
Address  OPD NO 1 DEPARTMENT OF KAUMARBHRITYA Dr D Y Patil College of Ayurveda and Research centre Postal address Sant Tukaram Nagar Pimpri Pune 4110 18 Telephone 020 27805899

Pune
MAHARASHTRA
4110 18
India 
Phone  9923220055  
Fax    
Email  drdeepak77@rediffmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil College of Ayurveda and Research centre Postal address Sant Tukaram Nagar Pimpri Pune 4110 18 Telephone 020 27122125 
 
Primary Sponsor  
Name  Dr mosim momin 
Address  Dr D Y Patil College of Ayurveda and Research centre Postal address Sant Tukaram Nagar Pimpri Pune 4110 18 Telephone 020 27122125 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr MOSIM MOMIN  Dr D Y Patil College of Ayurveda and Research centre   OPD NO 1 DEPARTMENT OF KAUMARBHRITYA Dr D Y Patil College of Ayurveda and Research centre Postal address Sant Tukaram Nagar Pimpri Pune 4110 18 Telephone 020 27805899
Pune
MAHARASHTRA 		 7350751503

dr.mosim2010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E441||Mild protein-calorie malnutrition. Ayurveda Condition: KARSYAM (KEVALAVATA), (2) ICD-10 Condition:E46||Unspecified protein-calorie malnutrition. Ayurveda Condition: KARSYAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: Baladi granules with standard undernutrition diet according to IAP, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: milk), Additional Information: Baladi granules with standard undernutrition diet according to IAP
2Intervention ArmDrugOther than Classical(1) Medicine Name: Baladi granules, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: milk), Additional Information: -
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Children age between 1 to 12 years.
2.Children whose weight for age is above 60 percent & below 80 percent of expected
weight (mild to moderate – grade 1 and grade 2) according to IAP
classification 
 
ExclusionCriteria 
Details  1.Children with severe symptomatic under nourishment.
2. Children with chronic/infective illnesses e.g.TB, immune compromised
disease etc.
3.Children with inborn errors of metabolism, malignancies and genetic
disorders.
4. Children whose weight for age is below 60% (severe-grade 3)& above 80%
of expected weight according to IAP classification. 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the add on effect of Baladi granules on weight gain in the management
of karshya vyadhi (mild to moderate undernutrition) in children 		 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the add on effect of Baladi granules on other parameters like
MUAC,height for age etc. in the management of karshya vyadhi (mild to moderate
undernutrition) in children 		 30 days 
 
Target Sample Size   Total Sample Size="116"
Sample Size from India="116" 
Final Enrollment numbers achieved (Total)= "122"
Final Enrollment numbers achieved (India)="122" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) 14/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Title:
A Randomized Controlled Clinical Study to Evaluate Add-on Effect of Baladi Granules in the Management of Karshya Vyadhi (Mild to Moderate Undernutrition) in Children .

Background:
Undernutrition (Karshya Vyadhi) remains a significant public health concern in India, particularly among children under five. Conventional approaches have limitations, especially in younger age groups. Baladi Granules, a proprietary Ayurvedic formulation, are designed to nourish the body tissues (Saptadhatus) and address Vata dosha imbalances associated with undernutrition.

Objectives:

Primary Objective: To assess the add-on effect of Baladi Granules on  weight gain in children with mild to moderate undernutrition.

Secondary Objectives: To evaluate the impact of Baladi Granules on other nutritional parameters such as MUAC and height-for-age.

Materials and Methods:

This 30-day, open-label, randomized controlled trial included 116 children aged 1–12 years with mild to moderate undernutrition. Participants were randomly allocated into two groups:

Group A: Received Baladi Granules (1 gm/year/day) with milk + standard undernutrition diet (IAP guidelines)

Group B: Received only the standard undernutrition diet
Anthropometric and clinical assessments were carried out at baseline, 15 days, and 30 days.

 

Results:
Group A showed statistically significant improvement in weight gain compared to Group B, fulfilling the primary objective. Secondary parameters including MUAC and height-for-age also improved significantly in Group A.

Statistical analysis using Wilcoxon Signed Rank Test, Paired t-Test, Mann-Whitney U Test, and Unpaired t-Test confirmed the efficacy of the intervention. A greater proportion of children in Group A experienced marked improvement (>75%) in overall health compared to Group B.

Conclusion:
Baladi Granules, as an adjunct to a standard diet, demonstrated significant benefits in improving weight, MUAC, and height-for-age in undernourished children. The formulation is a safe, effective, and affordable Ayurvedic intervention for the management of Karshya Vyadhi.

Limitations and Future Scope:

Short study duration and limited sample size. Future long-term, multi-center studies with biochemical parameters are recommended.


 
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