| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E02||Subclinical iodine-deficiency hypothyroidism. Ayurveda Condition: JATHARAGNIVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Lifestyle | - | - | 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. |