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CTRI Number  CTRI/2025/05/086963 [Registered on: 15/05/2025] Trial Registered Prospectively
Last Modified On: 14/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management of Dhatvagnimandya Vikrati (Hypothyroidism)Through Ayurveda  
Scientific Title of Study   A Comparative Study To Evaluate The Efficacy Of Shothahar Mahakashaya & Kanchanara Kashaya In The Management Of Dhatvagnimandya Vikrati (Hypothyroidism) 
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 Ankush 
Designation  MD Scholar 
Affiliation  Post Graduate Institute of Ayurved 
Address  P.G.Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Jodhpur RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  9653960229  
Fax    
Email  ankushbishnoi31@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Brahmanand Sharma 
Designation  Associate Professor 
Affiliation  Post Graduate Institute of Ayurved 
Address  P.G.Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Jodhpur RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  9460318138  
Fax    
Email  bkmudgal9@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ankush 
Designation  MD Scholar 
Affiliation  Post Graduate Institute of Ayurved 
Address  P.G.Department of Kayachikitsa Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Jodhpur RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  9653960229  
Fax    
Email  ankushbishnoi31@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur – 342037 (Rajasthan)  
 
Primary Sponsor  
Name  Post Graduate Institute of Ayurved  
Address  Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur – 342037 (Rajasthan)  
Type of Sponsor  Research institution and hospital 
 
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 Ankush  Post Graduate Institute of Ayurved   OPD Room No.6, Department of Kayachikitsa, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN 		 9653960229

ankushbishnoi31@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur   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: MANDAGNIH/ AGNISADA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shothahara Mahakashaya, Reference: Charak Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Panchkol Churna), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Kanchanar Kashaya. , Reference: Sharangdhar Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Panchkol Churna ), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients willing for the trial.

Patients between the age of 18 to 60 years of either sex.

Patients who are newly diagnosed of Hypothyroidism with increased TSH levels.

Subjects coming with chief complain of unexplained weight gain constipation hoarseness of voice fatigue.

Subjects detected with TSH 7 to 20 mIU per L.
 
 
ExclusionCriteria 
Details  Patients below the age of 18 years and above 60 years.
Patients suffering from congenital hypothyroidism and secondary hypothyroidism.
Subject having multi neoplasm, toxic goitre is excluded.
Patients who have undergone any type of thyroid surgery.
Pregnant and lactating women are excluded.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of changes in subjective parameters before and after trial.  From baseline, 30th day, 60th day, 90th day.  
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of changes in objective parameters before & after trial.  From baseline, 30th day, 60th day, 90th day.  
 
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)   06/08/2025 
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="0"
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 - NO
Brief Summary   A Comparative Study To Evaluate The Efficacy Of Shothahar Mahakashaya & Kanchanara Kashaya In The Management Of Dhatvagnimandya Vikrati (Hypothyroidism)

In this trial :

1. Group A 20 clinically diagnosed and registered patient of hypothyroidism will be given Panchkol Churna 3 gm orally twice a day before meal with 40 ml anupana of Shothhar MahaKashaya. 

 2. Group B 20 clinically diagnosed and registered patient of hypothyroidism will be given Panchkol Churna 3 gm orally twice a day before meal with 40 ml anupana of Kanchanar Kashaya. 

 
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