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CTRI Number  CTRI/2025/02/080040 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 04/02/2025
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   Testing the Effectiveness of Kanchnar Guggulu and Yoga in treating Subclinical Hypothyroidism 
Scientific Title of Study   A randomized open labelled comparative Clinical study to evaluate the efficacy of Kanchnar Guggulu & Yoga Practice in the Management of Subclinical 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 Jogender 
Designation  PG Scholar 
Affiliation  Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra  
Address  Opd no 2, PG Department of Swasthavritta and Yoga,Institute for Ayurved Studies and Research,Shri Krishna Ayush University Sector 8 Umri Road Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9050126752  
Fax    
Email  jogendersaini.96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jogender 
Designation  PG Scholar 
Affiliation  Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra  
Address  PG Department of Swasthavritta and Yoga,Institute for Ayurved Studies and Research,Shri Krishna Ayush University Sector 8 Umri Road Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9050126752  
Fax    
Email  jogendersaini.96@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jogender 
Designation  PG Scholar 
Affiliation  Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra  
Address  PG Department of Swasthavritta and Yoga,Institute for Ayurved Studies and Research,Shri Krishna Ayush University Sector 8 Umri Road Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9050126752  
Fax    
Email  jogendersaini.96@gmail.com  
 
Source of Monetary or Material Support  
Institute For Ayurved Studies and Research, Faculty of Ayurved,Shri Krishna Ayush University 136118 Kurukshetra  
 
Primary Sponsor  
Name  Institute For Ayurved Studies Research Shri Krishna Ayush University Kurukshetra Haryana 
Address  Institute For Ayurved Studies and Research, Faculty of Ayurved,Shri Krishna Ayush University Sector-8 Umri road Kurukshetra 136118 Haryana India 
Type of Sponsor  Other [Government Ayurvedic 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 Seema Rani  Institute For Ayurved Studies & Research, Shri Krishna Ayush University Kurukshetra, Haryana  Opd no 2, PG Department of Swasthavritta and Yoga,Institute for Ayurved Studies and Research,Shri Krishna Ayush University Sector 8 Umri Road Kurukshetra Haryana 136118
Kurukshetra
HARYANA 
09466786108

seemaranimd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SHRI KRISHNA AYUSH UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: JATHARAGNIVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: KANCHNAR GUGGULU, Reference: SARANGDHARA SAMHITA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -
2Intervention ArmLifestyle--Dinacarya: NO, Ritucarya: NO, Acara Rasayana:, Other:Yoga practice Duration - 40 minutes, The patients in the study group will be guided as per following yoga practice :- Sukshama vyayam ( warm up ) 3 Minutes Greeva sanchalan ( Neck movement ) 2 Minutes Sarvangasan (Shoulder stand pose ) 3 minutes Bhujangasan ( cobra poses ) 2 minutes Sequential ( Repeat ) 5 minutes Shavasan ( corpse position ) 1 minutes Kapalbhati pranayama 10 times Anulom vilom 15 times Bhramri pranayama 10 times Udgeeth pranayama 10 times Ujjayi pranayam 10 time, Pathya/Apathya:, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Newly diagnosed cases of subclinical hypothyroidism with TSH ranging from 5.5 to 10 uIU/ml.
2.Patients of subclinical hypothyroidism, irrespective of sex, religion, profession, etc.
3.Patients with an age limit of 19-60 years. 4.Patients ofsubclinical hypothyroidism willing to take ayurvedic medicine and sign the consent form. 
 
ExclusionCriteria 
Details 
1.Patients having ages below 19 years and more than 60 years.
2.Patient suffering from Primary hypothyroidism, and secondary hypothyroidism
3.Patients with hyperthyroidism, neoplasia, toxic goitre, and who have undergone any type of
thyroid surgery
4.Patient taking a known drug to alter thyroid hormone level (Eg. Amiodarone)
5.Pregnant ladies and lactating mothers
6.Patients having any other major complicated diseases like Cardiac disease, renal
failure, malignant disease, thyrotoxicosis & other systemic disorders
7.TPO (Thyroid Peroxidase) antibodies positive.
8.Taking OCP(Oral Contraceptive Pills) for longer duration.
9.Patient who take saindhav lavan or rock salt should not be included in trial, but after 3
monthes of introducing the iodinised salt IF TSH falls between 4- 10 uIU/ml than will
be included in trial.
10.Patient not willing to take the trial. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To normalized the serum TSH level in significant range.  Follow up for the objective parameters will be done on 30th day and 60th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the lab values of serum cholesterol, serum triglyceride and serum Creatinine.
2.Quality of life of patient will be improved. 
Follow up for the objective parameters will be done on 30th day and 60th day. 
 
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   Phase 2 
Date of First Enrollment (India)   15/02/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Thyroid gland is located in the front of neck which produces two hormones Thyroxin [T4] and Triiodothyronine [T3]. These hormones play a major role in cell differentiation during development and help in maintaining thermogenic and metabolic homeostasis in the body. Subclinical hypothyroidism is characterized by a serum TSH above the upper reference limit with a normal free thyroxin (T4) level. This is only applicable when the hypothalamic-pituitary thyroid axis is normal. Usually it runs a chronic course along with slow and insidious onset. At times patients are accidentally diagnosed when they come to seek treatment of other related problems or accompanying another person to a doctor. Thyroid gland abnormality influences body metabolism to a great extent and it also affects functioning of other glands. Thyroid hormone deficiency manifest as multi system involvement. lodine is the trace element required for the synthesis of thyroid hormone. The daily requirement of iodine recommended is 150ug/day, when there is iodine deficiency If left untreated it may result in severe complications with progressively increased mortality. The basic aim of treatment of SCH is to bring normalcy in TSH which reduces the incidence of clinical hypothyroidism and other complications.
Many diseases are not mentioned directly in Ayurveda texts called Anukta vikara. There is not a direct description of subclinical hypothyroidism found in Samhitas. Subclinical hypothyroidism refers to bio chemical evidence of thyroid hormone deficiency in patients who have few or no apparent clinical features of hypothyroidism The phase of compensation is when thyroid hormone levels are maintained by the rise in TSH. Although some patients may have minor symptoms, this state is called Subclinical hypothyroidism. It is defined as TSH level greater than 4.0 mIU/L and a normal free thyroxine level T4 &T3. Though there is a lack of direct description of this disease in our text, there is a description in Ashtanga hridaya that, if we don’t know the name of the disease then Vaidya should treat the patient with the examination of Prakriti, Adhistahna, Bheda, and Hetu. According to Ayurveda, subclinical ism can be considered as Anukta vikara and discussed as Kapha dushti, dhatwagnimandya janya vhadhi. However, a disease termed Galganda, characterized by neck swelling is described by Acharya Charak. Yoga is an ancient mind-body discipline that originated in India. Yoga is considered safe, can be easily learnt and can be practiced both indoors and outdoors. Yoga can be practiced across all genders and age groups Yoga is a discipline that includes body, breath, mind and behavior practices. It promotes a healthy lifestyle. Yoga brings many benefits to your overall health and well-being. It can balance your energy, increase flexibility, and relieve stress. Certain yoga poses are thought to balance out thyroids that are underactive. Yoga asanas such as sarvangasan, bhujangasan,followed by pranayama Most of these poses are considered throat-stimulating. They’re thought to improve circulation and energy flow around the thyroid gland, stretch and strengthen the neck and activates the thyroid gland.
 
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