A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in the treatment of subclinical hypothyroidism in adults
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Serum TSH level
研究概览
简要总结
Subclinical hypothyroidism (ICD 11-5A00.Z), characterized by elevated thyroid-stimulating hormone (TSH) levels alongside normal free thyroxine (T4) concentrations, poses a notable challenge in endocrine disorders. Prevalence estimates indicate that approximately 4% of adults in Western countries have overt hypothyroidism, with a significant rise to around 15% when including subclinical hypothyroidism. According to the epidemiological study that was conducted in eight cities in India, its prevalence is about 10.95%, out of which Kolkata recorded the highest number of cases [5]. In the study, 8.02% of individuals were diagnosed withsubclinical hypothyroidism [5]. Patients with subclinical hypothyroidism might exhibit symptoms similar to those observed in overt hypothyroidism. However, these symptoms are often nonspecific and may include fatigue, weight gain, constipation, dry skin, and mild cognitive impairment. The nuanced clinical picture of subclinical hypothyroidism—where the decision to treat hinges on a comprehensive assessment of age, risk factors, and comorbid conditions—underscores the need for individualized approaches. Previously, few clinical trials have been done in homoeopathy, most of which have shown promising results in lowering blood TSH levels through homeopathic intervention in the treatment of hypothyroidism.
Previously, exploratory and open-label single-arm trials were conducted. However, further studies are needed to confirm the efficacy of IHMs in hypothyroid adults. This trial is merely another attempt to detect and prove the efficacy of IHMs in reducing blood TSH levels by a 2:1 randomized ratio in 110 participants with prediabetes at the OPD of D.N. De Homoeopathic Medical College and Hospital. Assessment will be done by estimating the blood TSH, T3, and T4 levels; ZCS; and ThyPRO39, and the MYMOP2 questionnaire (secondary) will be measured monthly for up to 3 months. A comparative analysis will be conducted to detect group differences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Patients suffering from newly diagnosed subclinical hypothyroidism [ICD 11- 5A00.Z]
- •Serum TSH between 4.5 to 10 mIU/L, with normal T4 levels confirmed with biochemical investigation.
- •Age between 18 and 65 years
- •Patients of either sex, transgender.
排除标准
- •Not providing written informed consent for participation.
- •Diagnosed clinical cases of hypothyroidism
- •Vulnerable population—unconscious, ambulatory, too sick for consultation, disabled, terminally ill or critically ill patients; institutionalized subjects, mentally incompetent people
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
- •Pregnant and puerperal women, lactating mothers
- •Patient under tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
- •Self-reported immune-compromised state
- •Already undergoing homoeopathic treatment for chronic disease within last 6 months.
- •Simultaneous participation in any other clinical trials.
结局指标
主要结局
Serum TSH level
时间窗: At baseline and after 3 months
次要结局
- Blood T3 and T4 levels(At baseline and after 3 months)
- Thyroid-related quality of life (ThyPRO) questionnaire(At baseline, monthly, up to 3)
- Zuleswki’s clinical score (ZCS) for hypothyroidism(At baseline, monthly, up to 3)
- Measure Yourself Medical Outcome Profile version 2.0 (MYMOP-2)(At baseline, monthly, up to 3)
研究者
Sagar Saha
D N De Homoeopathic Medical College and Hospital