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CTRI Number  CTRI/2025/03/081498 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 22/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   a clinical comparative study to evaluate the efficacy of Kanchnar Guggulu Vatika and Hamsapadiadi Kashaya in the management of avatu granthi vikar w.s.r. Hypothyroidism 
Scientific Title of Study   a clinical comparative study to evaluate the efficacy of kanchnar guggulu vatika and hamsapadiadi kashaya in the management of avatu granthi vikar w.s.r. hypothyroidism 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VANDANA SIDAR 
Designation  PG Scholar Department of Kayachikitsa  
Affiliation  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 
Address  OPD number 02 and 18 Department of Kayachikitsa, Shri Narayan Prasad Awasthi Government Ayurveda College Raipur
Department of Kayachikitsa, Shri Narayan Prasad Awasthi Government Ayurveda College Raipur
Raipur
CHHATTISGARH
492010
India 
Phone  8770376276  
Fax    
Email  vs170530@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR S D KHICHARIYA 
Designation  Reader in Department of Kayachikitsa  
Affiliation  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 
Address  OPD number 2 and 18 Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurveda College Raipur

Raipur
CHHATTISGARH
492010
India 
Phone  8109196400  
Fax    
Email  drkhichariya@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR ARUNA OJHA  
Designation  Professor in Department of Kayachikitsa 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 
Address  OPD number 2 and 18 Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurveda College Raipur

Raipur
CHHATTISGARH
492010
India 
Phone  9424401858  
Fax    
Email  arunaojha90@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh, Pin 492010, India 
 
Primary Sponsor  
Name  Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurveda College Raipur  
Address  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh, Pin 492010, India 
Type of Sponsor  Other [Government Ayurveda College Raipur Chhattisgarh, 492010, India] 
 
Details of Secondary Sponsor  
Name  Address 
Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurveda College Raipur   Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vandana Sidar  Shri Narayan Prasad Awasthi Government Ayurveda College Raipur  opd number 02 and 18 and ipd in the Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurveda College Raipur
Raipur
CHHATTISGARH 
8770376276

vs170530@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE GOVERNMENT AYURVED COLLEGE RAIPUR (C.G.) 492010  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E038||Other specified hypothyroidism. Ayurveda Condition: GALAGANDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Hamsapadiadi Kashaya, Reference: Vaidyamanorama, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Kanchnaar Guggulu , Reference: Vangsen, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  It is based on clinical signs and symptoms mentioned in modern and ayurvedic classics, especially loss of appetite, puffiness, constipation, weight gain with the help of WHO Scoring of Ayurveda Symptoms. 
 
ExclusionCriteria 
Details  1.Patients below 18 years & above 60 years of age will not be taken.
2. Pregnancy & lactating mother.
3. TSH level more than 15.
4. T3 and T4 level are lower tahn normal.
5. Patients with a prior history of head and neck radiation.
6. patients having Hypothyroidism with complications.
7. Patients undergoing any known hormonal therapy.
8. The patients underwent any thyroid surgery or had an already diagnosed case of carcinoma.
9. Patients with long-term steroid treatment.
10. Recent participation in other clinical trial.
11. Severe mental disorder.
12. History of hypersensitivity to any of the trials and their ingredients.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduce the associated symptoms of Avatu Granthi Vikar (Hypothyroidism)  reduce the associated symptoms of Avatu Granthi Vikar in 8 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Improve the quality of life   90 Days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   01/04/2025 
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="1"
Months="0"
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  

Acharya Charaka categorize Hypothyroidism in Anukta Vyadhies means any disease which is not explained in Ayurvedic text but studied and treated on the basis of Kupit Dosha, Hetu, and their Sthan. The term Hypothyroidism is not mentioned directly in Ayurvedic texts, but the problems related to Thyroid Disorders were well described under the disorder known as Galaganda (Enlarged thyroid gland).

An analysis of the symptomatology of hypothyroidism, in the light of the Ayurvedic principle of Doshas & Dushya, showed in the Hypothyroidism there is a hypo activity of Agni at Koshta and Dhatu level with the analysis of  symptomatology of Hypothyroidism there’s a vatiation of Kapha-Vata Doshas . The lakshanas depend on the extent of involvement of Dhatus. So, the fundamental treatment principle in Hypothyroidism is to restore the Karmukata of Agni at both Kostha and Dhatu levels. This can be achieved through Ama Pachanam, Agni Deepanam, Srotosodhanam and administration of appropriate Rasayanam. Here Agni becomes diminished at the level of Dhatus and Sanga srotas which results in impairment of Dhatu function and leads to the symptoms as seen in hypothyroidism.[ By keeping all these things in my minds the select drugs will be fruitful in effective management of the disease rectifying Agnimandhya and Kapha-Medo dushti.

The volunteers will be informed about the study protocol and willing participants will be randomly selected as per the coin method. Clinical research format will be prepared and validated before the study approval will be taken from the IEC of the Shri NPA Govt. Ayurved College and hospital, Raipur C.G. and CTRI registration will be done. After selection, each participant will be tasted individually and selected according to the assessment criteria. Sixty patients of Avatu Granthi Vikar will be selected from Kayachikitsa OPD and IPD Shrihri NPA government Ayurved college and hospital, Raipur C.G. The

case selection was in regards to age, sex, occupation, and socio-economic conditions. Both acute and chronic phases of Avatu Granthi Vikar patients were taken for the study, following the WHO scoring of Ayurveda Symptoms’s criteria for diagnosing Avatu Granthi Vikar as well as the clinical features of Hypothyroidism described in modern medicine. The present study is a single-center, open-labeled randomized (coin method) clinical trial. A total of 60 clinically diagnosed and registered patients of  Hypothyroidism were divided randomly by coin method into three groups. Each group will have 20 patients. Group A: 20 clinically diagnosed patients of Hypothyroidism will be treated with Kanchnar Guggulu Vatika 2 tablets (each 500 mg) two times in a day with lukewarm water before meal for 90 days. Group B: 20 clinically diagnosed patients of Hypothyroidism were treated with Hmasapadiadi Kashaya 40 ml two times in a day before meal with anupana madhu for 90 days along. Group C: 20 patients diagnosed with Avatu Granthi Vikar were treated with both trial drugs Kanchnar Guggulu Vatika (2Tab) and Hamsapadiadi Kashaya (40ml) two times a day before meal.

 
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