FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/10/058297 [Registered on: 05/10/2023] Trial Registered Prospectively
Last Modified On: 27/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare the effect of Vidaryadi modak and Priyaladi modak in Underweight children 
Scientific Title of Study   Prospective comparative open clinical study of brumhana effect of vidaryadi modak and priyaladi modak in balkarshya with special reference to underweight 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 Megha Deepak Posugade 
Designation  Post Graduate Scholar 
Affiliation  Hon Shri Annasaheb Dange Ayurved Hospital and Research Centre Ashta 
Address  OPD no 10 Balrog OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli Sangli MAHARASHTRA 416301 India

Sangli
MAHARASHTRA
416301
India 
Phone  8308782144  
Fax    
Email  meghaposugade96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nareshkumar Keshav Babar  
Designation  Reader 
Affiliation  Hon Shri Annasaheb Dange Ayurved Hospital and Research Centre Ashta 
Address  OPD no 10 Balrog OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli Sangli MAHARASHTRA 416301 India

Sangli
MAHARASHTRA
416301
India 
Phone  7507595454  
Fax    
Email  dr.nareshbabar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nareshkumar Keshav Babar  
Designation  Reader 
Affiliation  Hon Shri Annasaheb Dange Ayurved Hospital and Research Centre Ashta 
Address  OPD no 10 Balrog OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli Sangli MAHARASHTRA 416301 India

Sangli
MAHARASHTRA
416301
India 
Phone  7507595454  
Fax    
Email  dr.nareshbabar@gmail.com  
 
Source of Monetary or Material Support  
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre Ashta  
 
Primary Sponsor  
Name  Dr Megha Deepak Posugade 
Address  OPD no 10 Balrog OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli Sangli MAHARASHTRA 416301 India 
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 Megha Deepak Posugade  Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta  OPD no 10 Balrog OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal WalWa Dist Sangli Sangli MAHARASHTRA
Sangli
MAHARASHTRA 		 8308782144

meghaposugade96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E639||Nutritional deficiency, unspecified. Ayurveda Condition: BALAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Priyaladi Modak, Reference: Ashtang Hriday, Route: Oral, Dosage Form: Modaka , Dose: 11(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Godugdha), Additional Information: Drug should be given with stipulated diet
2Intervention ArmDrugClassical(1) Medicine Name: Vidaryadi Modak, Reference: Yogratnakar, Route: Oral, Dosage Form: Modaka , Dose: 11(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Godugdha), Additional Information: Drug should be given with stipulated diet
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1 Subjects within age group 6 to 12 years will be included in the study irrespective of sex socioeconomic status caste and religion
2 The weight of children is 60 to 80 percent of ideal weight expected for their age and without oedema 
 
ExclusionCriteria 
Details  Underweight children associated with
1 Any infective diseases like Rubella syphilis Hepatitis B HIV CMV Toxoplasmosis
2 Children with chronic systemic diseases like Chronic Renal Failure
3 The weight of children below 60 percent of ideal weight expected for their age
4 Protein Energy Malnutrition Kwashiorkar Marasmus and Marasmic Kwashiorkar 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the weight gain effect of Vidaryadi Modak and Priyaladi Modak in Balkarshya  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the changes in general appearance of child
and weight gain effect by consuming Vidaryadi Modak & Priyaladi Modak in balkarshya 		 8 weeks 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   10/10/2023 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [meghaposugade96@gmail.com].

  6. For how long will this data be available start date provided 24-12-2024 and end date provided 26-12-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   As we see the number of children with balkarshya are increasing now a days so this study will help the children for better and early management The brumhana effect of Vidaryadi Modak and Priyaladi Modak will be compared in the management of Balkarshya with special reference to underweight children Both the drugs will be given orally with milk in the diagnosed children for sixty days and follow up will be done every fifteenth day 46 patients in each group will be studied Outcome of the study will be assessed as per selected parameters 
Close