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CTRI Number  CTRI/2023/03/050606 [Registered on: 13/03/2023] Trial Registered Prospectively
Last Modified On: 11/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic trial for treatment of hypothyroidism  
Scientific Title of Study   A Randomized Control Trial to Evaluate the Efficacy of Ashwagandha Ghrita Snehapana with Ashwagandha Kwatha in Management of Hypothyroidism 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Poonam Bansal 
Designation  PG Scholar  
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan 
Address  Room no.123, PG Dept. of Panchakarma,Ch. Brahm Prakash Ayurved Charak Sansthan,khera dabar,Najafgarh Southwest DELHI 110073 India

South West
DELHI
110073
India 
Phone  9785869901  
Fax    
Email  meghabansal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Arun Gupta  
Designation  Professor and Head of Department 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan 
Address  Room no.142, PG Dept.of panchkarma,Ch.Brahm Prakash Ayurved Charak Sansthan,khera dabar,Najafgarh Southwest DELHI 110073 India

South West
DELHI
110073
India 
Phone  8178361290  
Fax    
Email  arun24@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Arun Gupta  
Designation  Professor and Head of Department 
Affiliation  Ch. Brahm Prakash Ayurved Charak Sansthan 
Address  Room no.142, PG Dept.of panchkarma,Ch.Brahm Prakash Ayurved Charak Sansthan,khera dabar,Najafgarh Southwest DELHI 110073 India

South West
DELHI
110073
India 
Phone  8178361290  
Fax    
Email  arun24@hotmail.com  
 
Source of Monetary or Material Support  
Ch Brahm Prakash Ayurved Charak Santhan 
 
Primary Sponsor  
Name  Ch Brahm Prakash Ayurved Charak Santhan 
Address  PG dept. of panchakarma,Ch Brahm Prakash Ayurved Charak Santhan,Khera Dabar ,Najafgarh,New Delhi -110073 
Type of Sponsor  Government medical college 
 
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 poonam bansal  ch.brahm prakash ayurved charak sansthan  OPD and IPD PG department of panchakarma Ch. Brahm Prakash Ayurved Charak Santhan,Khera Dabar ,Najafgarh,New Delhi -110073
South West
DELHI 		 9785869901

meghabansal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-CBPACS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: GALAGANDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Ashwagandha kwatha, Reference: Bhawaprakasha samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Mandoshna jala), Additional Information: -
2Intervention ArmProcedure-snehapAna-karma, स्नेहपान-कर्म (Procedure Reference: Ashtang hridya sutrasthana 16/19, Procedure details: Ashwagandha ghrita 20 ml as shamaana snehapnana will be given in morning (empty stomach) for consecutive 30 days.)
(1) Medicine Name: Ashwagandha ghrita, Reference: bhawaprakash samhita, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Duration: 30 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1)Either Fresh or Subjects Prediagnosed with Hypothyroidism Which Are on Regular Thyroxine (up to 50 Mcg).
2)TSH Level Between 6 To10 mIU.
3)DAS Scale-42 values mild to moderate.  
 
ExclusionCriteria 
Details  1)Pregnant and Lactating Women.
2)Subjects Having Any Other Chronic Systemic Disease.
3)DAS Scale-42 values severe to extremely severe. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Ashwagandha Ghrita Snehapana may shows better improvement in Thyroid Profile in comparison to Ashwagandha Kwatha in management of Hypothyroidism.  0 days,30 days and 45 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Ashwagandha Ghrita Snehapana may shows better results in signs and symptoms of Hypothyroidism.
Ashwagandha Ghrita Snehapana may shows better results in DAS Scale 		 30 days. 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   15/03/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The study is to compare the effect of Ashwagandha Ghirta Snehapana and Ashwagandha Kwatha in management of Hypothyroidism. In one group Ashwagandha Ghrita Snehapana orally 2 Karsha (approximately 20ml) empty stomach will be given for consecutive 30 days.
in another group Ashwagandha Kwatha orally 40 ml empty stomach will be given for consecutive 30 days. the trial will conduct in ch. brahm prakash ayurved charak sansthana with outcome Ashwagandha Ghrita Snehapana may shows better results on Ashwagandha Kwatha in management of Hypothyroidism.
 
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