| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E039||Hypothyroidism, unspecified. Ayurveda Condition: DHATUVAISHAMYAM, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: N/A, Ritucarya: N/A, Acara Rasayana:N/A, Other:Bhramari Pranayama, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm | Lifestyle | - | - | 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
|
|
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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 |