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CTRI Number  CTRI/2026/03/106569 [Registered on: 19/03/2026] Trial Registered Prospectively
Last Modified On: 18/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   A Study on the effect Yoga Breathing Techniques and Ayurveda medicine in Hypothyroidism management 
Scientific Title of Study   An open labelled randomized comparative study to evaluate the effect of Ujjayi Pranayama and Bhramari Pranayama along with Kanchanara Guggulu in the management of 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 Sushmitha M 
Designation  Post Graduate Scholar 
Affiliation  Government Ayurveda Medical College 
Address  Department of Swasthavritta and Yoga, Government Ayurveda Medical College, Visvesvaraya Circle Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka

Mysore
KARNATAKA
570001
India 
Phone  9916989367  
Fax    
Email  sushmitha102000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SUDHEENDRA G NAWALE  
Designation  Professor 
Affiliation  Government Ayurveda Medical College 
Address  Department of Swasthavritta and Yoga, Government Ayurveda Medical College, Visvesvaraya Circle, Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka

Mysore
KARNATAKA
570001
India 
Phone  9341061821  
Fax    
Email  sudheernavale@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sushmitha M 
Designation  Post Graduate Scholar 
Affiliation  Government Ayurveda Medical College 
Address  Department of Swasthavritta and Yoga, Government Ayurveda Medical College, Visvesvaraya Circle, Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka

Mysore
KARNATAKA
570001
India 
Phone  9916989367  
Fax    
Email  sushmitha102000@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College, Visvesvaraya Circle, Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka 
 
Primary Sponsor  
Name  Dr Sushmitha M 
Address  Government Ayurveda Medical College, Visvesvaraya Circle, Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka,India, 570001 
Type of Sponsor  Other [Self] 
 
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 SUSHMITHA M  Government Ayurveda Medical College and Hospital  Room 12, Department of Swasthavritta and Yoga, Mysuru, Karnataka
Mysore
KARNATAKA 
9916989367

sushmitha102000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Ayurveda Medical College and Hospital Mysuru  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: DHATUVAISHAMYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: N/A, Ritucarya: N/A, Acara Rasayana:N/A, Other:Bhramari Pranayama, Pathya/Apathya:no, Pathya:, Apathya:
2Comparator ArmLifestyle--Dinacarya: N/A, Ritucarya: N/A, Acara Rasayana:N/A, Other:Ujjayi Pranayama, Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects of the age group between 20 to 60 years fulfilling the diagnostic criteria will be selected for the study
Subjects with a TSH value greater than 4mIU/L to less than 25mIU/L may or may not be associated with the reduced value of T3 and T4
Diagnosed case of hypothyroidism within 5 years
 
 
ExclusionCriteria 
Details  Subjects with a diagnosed case of congenital hypothyroidism, a chronic history of hypothyroidism, and secondary hypothyroidism
Subjects having any of he diagnosed systemic illnesses like Chronic respiratory disease, chronic heart disease, etc
Pregnant and lactating women
Subjects who have undergone any thyroid surgery.
Subjects unfit for pranayama techniques like acute illnesses (fever, acute respiratory infections, etc), recent cardiac events, etc
 
 
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 
Reducing TSH value and comparing the zulewski clinical score for hypothyroidism  48th day 
 
Secondary Outcome  
Outcome  TimePoints 
reduction in the symptoms of Hypothyroidism like weight gain, Hair loss, Stiffness of joints,Hair loss, Diminished sweating ,Dryskin, Constipation  48th day 
 
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)   10/04/2026 
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="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  
Hypothyroidism is a hypo-metabolic clinical state resulting from inadequate production of thyroid hormone. Among endocrine abnormalities thyroid diseases are the most common both in India and worldwide. The prevalence of hypothyroidism in India is 11percent compared with only 2 percent-4.6 percent in the Western population Women are affected approximately six times more frequently than men. Symptoms of hypothyroidism include lethargy dry hair and skin cold intolerance hair loss difficulty in concentration poor memory constipation weight gain with poor appetite dyspnea hoarse voice muscle cramping and menorrhagia.The normal as well as the abnormal function of the thyroid gland can be correlated to the healthy and altered status of Agni While analyzing the signs and symptoms of Hypothyroidism in Ayurvedic view in hypothyroidism, there is abnormality of Jatharagni and Dhatwagni is seen along with abnormality of Vata and Kapha dosha  Kanchanara Guggulu is a classical ayurvedic formulation which is proven effective in treating Hypothyroidism and other metabolic disorders. Pranayama is generally defined as breath control  The breath is the most vital process of the body It influences the activities of each and every cell and most importantly is intimately linked with the performance of the brain In Hatayoga Pradeepika it is mentioned that Ujjayi Pranayama removes Kapha from the throat and stimulates the Agni  The vibration of the humming sound in the Bhramari Pranayama creates a soothing effect on the mind and nervous system and it eliminates throat ailments. Available treatment options for thyroid dysfunctions are hormone replacement therapy antithyroid medications radioactive iodine therapy beta-blockers to manage symptoms and in some cases, surgery. These treatments can impose a financial burden on patients. Pranayama is a cost-effective mind-body approach that is simple to practice  Hence this study is designed to evaluate the effect of Ujjayi Pranayama with Kanchanara Guggulu and Bhramari Pranayama with Kanchanara Guggulu and also to compare their efficacy with one another in hypothyroidism
 
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