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)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
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 significant stress. Therefore, conducting a study in this area is imperative.
Objective:
To assess the effectiveness of 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 a duration of 180 days. The control group (n=45) will be given Tab. Levothyroxine at a dosage of 1.6 µgm/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 TSH by more than 20% from the initial values, while keeping T3 and 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
Conclusions:
This study aims to ascertain the efficacy of the therapeutic enema, known as Kshar Basti, in the management of hypothyroidism. In addition, additional research can determine whether a therapeutic enema (Kshar Basti) can effectively treat overt Hypothyroidism. Clinical Trial: CTRI/2023/05/052389 [Registered on: 09/05/2023] Trial Registered Prospectively [1] version 2.
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