FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072348 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 09/08/2024
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   To check the effectiveness of Vachai Choorna in Karshya, (Malnutrition)- A randomized controlled clinical study.  
Scientific Title of Study   A Randomized Controlled Clinical study to evaluate the efficacy of Vachadi Choorna in Karshya  
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 Pawar Anuja Samindar  
Designation  PG Scholar 
Affiliation  Alvas Ayurveda medical college and Hospital 
Address  Alvas Ayurveda Medical College and Hospital, Moodubidri, Dakshin Kannada Karnataka 574227,Kaumarbhrityq department Ground floor Room number 2.
Alvas Ayurveda Medical College and Hospital, Moodubidri, Dakshin Kannada Karnataka 574227,Kaumarbhritya department Ground floor Room number2 .
Dakshina Kannada
KARNATAKA
574227
India 
Phone  9665074912  
Fax    
Email  anujapawar726@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pawar Anuja Samindar  
Designation  PG Scholar 
Affiliation  Alvas Ayurveda medical college and Hospital 
Address  Alvas Ayurveda Medical College and Hospital, Moodubidri, Dakshin Kannada, Karnataka 574227,Kaumarbhritya department, Ground floor, Room no 2
Alvas Ayurveda Medical College and Hospital, Moodubidri, Dakshin Kannada, Karnataka 574227,Kaumarbhritya department, Ground floor, Room no 2
Dakshina Kannada
KARNATAKA
574227
India 
Phone  9665074912  
Fax    
Email  anujapawar726@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jithesh Chowta  
Designation  Associate professor 
Affiliation  Alvas Ayurveda medical college and Hospital Moodubidri 
Address  Associate professor Department of Kaumarbhritya Alvas Ayurveda medical college and Hospital, moodubidri Karnataka 574227, Kaumarbhritya Department, Ground floor, room number 2
Associate professor Department of Kaumarbhritya Alvas Ayurveda medical college and Hospital, moodubidri Karnataka 574227, Kaumarbhritya Department, Ground floor, room number 2
Dakshina Kannada
KARNATAKA
574227
India 
Phone  9164123167  
Fax    
Email  jitheshchowta@gmail.com  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  Dr Pawar Anuja Samindar  
Address  Alvas Ayurveda medical college and Hospital moodubidri Dakshin Kannada 574227 
Type of Sponsor  Other [] 
 
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 Pawar Anuja Samindar  Alvas Ayurveda medical college and hospital, moodubidri Dakshin kannada   Alvas Ayurveda medical college and Hospital Moodubidri karnataka Kaumarbhritya OPD room number 2
Dakshina Kannada
KARNATAKA 		 9665074912

anujapawar726@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Alvas Ayurveda medical college  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),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Masha Ashwagandhadi Choorna , Reference: Sahasrayoga , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Dugdha ), Additional Information: -For 5 to 7 years 6g BID For 8 to 10 years 9g BID
2Intervention ArmDrugClassical(1) Medicine Name: Vachadi Choorna , Reference: Harita samhita 3/54/22, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Ghrita ), Additional Information: -For 5 to 7 yers 6 g BID 8 to 10 years 9g BID
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA:
a. Subject irrespective of gender, religion, and socioeconomic status.
b. Age group – 5 to 10 years.
c. Grade 1(71-80%) and Grade 2(61-70%), IAP Classification of malnutrition (Based on weight
for age of standard.) 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA
By assessing the clinical signs and symptoms, subjects with Systemic illness and
Endocrine disorders, Subjects of known Congenital anomalies and Genetic defects will be excluded.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the weight gain depending upon subjective and objective parameters  90 Days  
 
Secondary Outcome  
Outcome  TimePoints 
To improve the nutritional status.   90 
 
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 2/ Phase 3 
Date of First Enrollment (India)   01/11/2024 
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="15" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   The study is randomized, controlled, comparative clinical study  with the standard drug Masha Ashwagandhadi Choorna and Interventional drug Vachadi Choorna with the dosage of 6 gms for 5 to 7 years and 9 gms for 8 to 10 years , twice a day before food with anupan of Dugdha for Masha Ashwagandhadi group and Ghrita for Vachadi Choorna group. The study is conducting on subjects of Karshya belonging to age of 5 to 10 years who has given written and verbal concent by parents for underrgoing clinical study. Study will be conducting in Alvas Ayurveda medical college and Hospital moodubidri. Interventional period of this study is 90 days, assessment will be done before treatment,  30th, 60th, and 90 th day.  
Close