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Clinical Trials/CTRI/2025/02/080040
CTRI/2025/02/080040RecruitingPhase 2

A randomized open labelled comparative Clinical study to evaluate the efficacy of Kanchnar Guggulu & Yoga Practice in the Management of Subclinical Hypothyroidism

Institute For Ayurved Studies Research Shri Krishna Ayush University Kurukshetra Haryana1 site in 1 country60 target enrollmentStarted: February 15, 2025Last updated:

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To normalized the serum TSH level in significant range.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
19.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

To normalized the serum TSH level in significant range.

Time Frame: Follow up for the objective parameters will be done on 30th day and 60th day.

Secondary Outcomes

  • Improvement in the lab values of serum cholesterol, serum triglyceride and serum Creatinine.(2.Quality of life of patient will be improved.)

Investigators

Sponsor
Institute For Ayurved Studies Research Shri Krishna Ayush University Kurukshetra Haryana
Sponsor Class
Other [Government Ayurvedic College]
Responsible Party
Principal Investigator
Principal Investigator

Dr Jogender

Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra

Study Sites (1)

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