Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 11, 2024
Open Peer Review Period: Feb 12, 2024 - Apr 8, 2024
Date Accepted: May 8, 2024
(closed for review but you can still tweet)
Evaluation of Comparative Efficacy of Levothyroxine versus Kshar Basti and Kanchanar Guggul in the Treatment of Hypothyroidism: A Study Protocol for Randomized Control Trial
ABSTRACT
Background:
The thyroid gland is an endocrine gland that has an impact on the body's general metabolism. Thus, the secretions of the thyroid gland can modify the overall metabolism of the entire body. The prevalence of hypothyroidism is increasing quickly, with rates of 2- 5% in affluent countries and 11% in India. Individuals diagnosed with hypothyroidism need to take medication for the rest of their lives, resulting in a significant stress. Therefore, conducting a study in this area is imperative.
Objective:
To assess the effectiveness of the therapeutic enema (Kshar Basti) and oral Kanchnar Guggul in the treatment of hypothyroidism.
Methods:
The study group (n=45) will receive a therapeutic enema (Kshar Basti) followed by oral Ayurvedic drugs for 180 days. The control group (n=45) will be given Levothyroxine tablets at a dosage of 1.6 µg/kg/day for the same duration. The objective is to examine the alterations in TSH levels before and after the treatment.
Results:
Any deviation of the serum Thyroid Stimulating Hormone (TSH) by more than 20% from the initial values, while keeping Triiodothyronine (T3), and Thyroxine (T4) levels within the normal range, will be deemed statistically significant. Consequently, we anticipate a statistically significant variation in serum TSH levels between the therapeutic enema and Kanchanar Guggul treatments. Presently, the drug preparation operations are in progress. We anticipate commencing patient recruitment in June 2024, conducting data analysis in June 2025, and obtaining results by the conclusion of the year 2025.
Conclusions:
This study will evaluate the efficacy of the therapeutic enema, specifically Kshar Basti, in treating hypothyroidism. Furthermore, more research can determine the efficacy of a therapeutic enema (Kshar Basti) in treating overt hypothyroidism and hypothyroidism during pregnancy. Clinical Trial: Trial Registration: CTRI/2023/05/052389 [Registered on: 09/05/2023] Trial Registered Prospectively version 2.
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