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CTRI Number  CTRI/2026/02/103900 [Registered on: 16/02/2026] Trial Registered Prospectively
Last Modified On: 14/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Evaluation of kanchanaradi yoga in the management of hypothyroidism 
Scientific Title of Study   Randomized controlled clinical study to evaluate the effecacy of kanchanaradi yoga in the management of primary hypothyroidism 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NILL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pooja Tushar Deshpande 
Designation  Associate Professor  
Affiliation  Shree Saptashrungi Ayurved Mahavidyalaya and Hospital 
Address  Department of Kayachikitsa, Shree Saptashrungi Ayurved Mahavidyalaya, Kamal nagar, Hirawadi, Panchavati, Nashik, Maharashtra INDIA 420003

Nashik
MAHARASHTRA
422003
India 
Phone  8983215612  
Fax    
Email  poojakulkarni379@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Somdatta Bhaskarrao Kulkarni 
Designation  Professor and HOD 
Affiliation  Shree Saptashrungi Ayurved Mahavidyalaya and Hospital 
Address  Department of Kayachikitsa, Shree Saptashrungi Ayurved Mahavidyalaya, Kamal nagar, Hirawadi, Panchavati, Nashik, Maharashtra INDIA 422003

Nashik
MAHARASHTRA
422003
India 
Phone  9860268117  
Fax    
Email  somdattak85@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Somdatta Bhaskarrao Kulkarni 
Designation  Professor and HOD 
Affiliation  Shree Saptashrungi Ayurved Mahavidyalaya and Hospital 
Address  Department of Kayachikitsa, Shree Saptashrungi Ayurved Mahavidyalaya, Kamal nagar, Hirawadi, Panchavati, Nashik, Maharashtra INDIA 422003

Nashik
MAHARASHTRA
422003
India 
Phone  9860268117  
Fax    
Email  somdattak85@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr. Pooja Tushar Deshpande 
Address  Department of Kayachikita, Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamal Nagar Hirawadi Panchavati Nashik 422003 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NILL  NILL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pooja Tushar Deshpande  shree Saptashrungi Ayurveda Mahavidyalaya   Department of Kayachikitsa, Shree Saptashrungi Ayurved Mahavidyalaya, Kamal nagar, Hirawadi, Panchavati, Nashik, Maharashtra INDIA 422003
Nashik
MAHARASHTRA 		 8983215612

poojakulkarni379@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SAPTASHRUNGI AYURVED COLLEGE   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 Arm (Non Ayurveda)-TAB. LEVOTHYROXINE TAB - LEVOTHYROXINE OD DOSE- 1 MCG/KG ROUTE OF ADMINISTRATION - ORAL TIMING - MORNING BEFORE FOOD
2Intervention ArmDrugOther than Classical(1) Medicine Name: KANCHANARADI YOGA, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: HOT WATER ), Additional Information: Each 500 mg tablet contains following ingredients- 1) KANCHANRA 75MG 2) PIPPALI 50MG 3) VIDANG 50MG 4) CHITRAKA 50MG 5) KUTAKI 25MG 6) SHUDDHA GUGGULU 250MG
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Newly diagnosed patient with signs and symptoms of Primary hypothyroidism having
deranged TFT LEVEL 6 TO 20
Patient with DM HTN and IHD without any complication and having deranged TFT
LEVEL 6 TO 20
Auto immune thyroid disorder Hashimoto thyroiditis TPO LEVEL FROM 34 TO 200
Patient with history of drug intake like Amiodarone lithium interferon alpha and
interleukin 
 
ExclusionCriteria 
Details  1) Pregnant and lactating mother.
2) Patient having myxedematous coma.
3) Patient diagnosed with hypothyroidism due to pituitary dysfunction i.e., secondary
hypothyroidism.
4) Congenital hypothyroidism
5) Hypothyroidism due to excessive radiation therapy in treating certain cancer like
lymphoma.
6) Patient having malignancy of thyroid gland and any other life-threatening diseases. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) To assess the efficacy of Kanchanardi yoga and Levothyroxine when administered for
2 months on patients having deranged TFT level, TPO antibody level and weight of
patient.

2) To assess the efficacy of Kanchanaradi yoga and Levothyroxine in Lazyness (Alasya),
General Debility (Daurbalya), Hair Fall (Keshapatan) and Increased Sleep (Atinidra)
when administered for 2 months. 		 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
NILL  NILL 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   02/03/2026 
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 - NO
Brief Summary   Hypothyroidism is one of the common lifestyle disorders found in India. The prevalence of hypothyroidism is high, almost 10.9% adults in the study population. Female gender and older age were found to have significant association with hypothyroidism. so, it is the need of today’s era to study the disease hypothyroidism in detail in modern as well as ayurvedic perspective. In ayurveda, there is no direct reference of Primary Hypothyroidism. Charak Samhita has mentioned that every disease cannot be named but it can be considered as Anukta Vyadhi. The treatment should be done according to Rogaprakruti, vyadhi Adhishthan and Samutthan and also Dosha and Dushya involved. Kanchanaradi yoga will be given for 2 months which contain Kanchanara, Pippali, Vidang, Kutaki and Chitraka. Chitraka itself is symbolised as AGNI. Thus, it does agnisandhukshana i.e. it increases digestion power of patient. Research has been done on Kanchanra that it is the drug which directly stimulates the Thyroid secretions. Pippali and Vidang are ushna, tikshna and deepan, pachan, dravya. It does rasa dhatu and kapha dosha pachan and regularise their proper metabolism. Kutaki acts on Yakrut i.e. Liver, it increases pachakagni of patient and rasa dhatu, kapha dosha pachana.  
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