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临床试验/CTRI/2021/03/031671
CTRI/2021/03/031671招募中2/3 期

Effects of individualized homeopathic medicines in hypothyroidism: Double-blind,randomized, placebo-controlled, feasibility trial

D N De Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年8月3日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
32
试验地点
1
主要终点
Blood TSH level

研究概览

简要总结

Hypothyroidism is a condition in which the thyroid gland doesn’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.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

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

排除标准

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

结局指标

主要结局

Blood TSH level

时间窗: At baseline and after 3 months

次要结局

  • 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)

研究者

发起方
D N De Homoeopathic Medical College and Hospital
申办方类型
Government medical college

研究点 (1)

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