Homeopathy for thyroid problems

Phase 2/3

Recruiting

Conditions: Hypothyroidism, unspecified,

Registration Number: CTRI/2021/03/031671

Lead Sponsor: D N De Homoeopathic Medical College and Hospital

Brief Summary: Hypothyroidism is a condition in which the thyroid gland doesnâ€™t produce enough thyroid hormone, resulting disruption of heart rate, body temperature and all aspects of metabolism. Hypothyroidism is found in about 2% of the UK population and in India overall prevalence is 10.95%. Standard treatment for hypothyroidism involves daily use of the synthetic thyroid hormone levothyroxine (Levo-T, Synthroid, others) with various adverse effects. Homeopathy remains a popular choice of treatment among sufferers, yet evidence of efficacy trial with individualized homeopathy is scarce. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 32 patients suffering from hypothyroidism will be randomized to receive either individualized homeopathic medicines (verum; n=16) or identical-looking placebo (control; n=16). We aim to address the feasibility issues of conducting a definitive efficacy trial of individualized homeopathic medicines in treatment of hypothyroidism and to investigate whether there are any differences in outcomes between these two groups over 3 months of intervention. Thyroid profiles (TSH, FT3 and FT4), Zulewski clinical score for hypothyroidism (ZCSH) and Thyroid symptoms questionnaire (TSQ) will be used as the primary and secondary outcome measures respectively. Feasibility issues will be checked and comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 32

Inclusion Criteria

Newly diagnosed cases of hypothyroidism (serum TSH 4.25 Î¼IU/ml or more) (2018/2019 ICD-10 Code E03.9) and not taking levothyroxine sodium 2.
Age 18-65 years 3.
Patients of either sex 4.
Patients who are literate and capable of filling the questionnaire and providing informed consent.

Exclusion Criteria

Blood TSH above 50 mIU/ml 2.
Patients suffering from congenital hypothyroidism 3.
Patients with psychiatric diseases 4.
Cases suffering from any other uncontrolled systemic illness or life threatening infections or any vital organ failure 6.
Cases already undergoing homeopathic treatment for any chronic purpose 7.
Substance abuse and/or dependence.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood TSH level	At baseline and after 3 months

Secondary Outcome Measures

Name	Time	Method
Blood FT3 and FT4	At baseline and after 3 months
Zulewski clinical score for hypothyroidism	At baseline and after 3 months
Thyroid symptoms questionnaire	At baseline and after 3 months

Trial Locations

Locations (1): D. N. De Homoeopathic Medical College and Hospital
🇮🇳
Kolkata, WEST BENGAL, India
D. N. De Homoeopathic Medical College and Hospital
🇮🇳Kolkata, WEST BENGAL, India
Sk Monsur Alam
Principal investigator
8240152722
drmonsur1982@gmail.com