Efficacy of Homoeopathic Medicine Thyroidinum 3X in Treatment of Hypothyroidism among 18-65 years aged assessing Thyroid Function Test: A Double-Blind, Randomized, Placebo-Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Thyroid Stimulating Hormone
研究概览
简要总结
Hypothyroidism is characterized by a wide spectrum of severity, ranging from the overt form marked by myxoedema, significant endorgan involvement and multisystem compromise, to asymptomatic subclinical presentation. It clinically manifested with fatigue and muscle weakness, alongside dry, coarse skin and sensitivity to cold, hair thinning, difficulty concentrating with memory lapses, constipation, unexplained weight gain despite a poor appetite, and menstrual disturbances. Thyroid disorders rank as the most prevalent endocrine condition both in India and across the globe. ICD10 code for hypothyroidism diagnosis is E03.9, and 5A00.Z for latest ICD11. Kolkata leads Indian cities with a hypothyroidism prevalence of 21.6 percentage, while other urban cities report rates between 8.8 percentage in Hyderabad and 11.07 percentage in Delhi. Untreated hypothyroidism can result in serious cardiovascular and neurological complications. Homoeopathic medicine, Thyroidinum is a sarcode, prepared form of sheep or calf thyroid gland, used for treating various thyroid imbalances. This randomized, double blind, placebo controlled trial is designed to evaluate the efficacy of homeopathic Thyroidinum 3X in adults with hypothyroidism and fulfil the existing research gap.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Patient having Zulewski clinical score more than 3 points.
- •Patients having serum TSH levels (more than 4.5 to lesser equal to 12 µIU/ml).
- •Patients of age between 18 and 65 years.
- •Patients of either sex or transgender.
- •Patients may have symptoms of homoeopathic medicine Thyroidinum.
- •Literate patients willing to take part in the study and ready to give written consent for the same.
排除标准
- •Zulewski clinical score lesser than 3 points.
- •Patients having serum TSH level greater than 12 µIU/ml.
- •Patients under-going any treatment for thyroid dysfunction.
- •Illiterate patients and/or patients not giving written informed assent and/or consent to participate.
- •Vulnerable population–unconscious, non-ambulatory, too sick for consultation, terminally or critically ill patients, mentally incompetent people.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life threatening illness led to any organ failure.
- •Pregnant, Lactating mother, Substance abuse and/or dependence.
- •Self-reported immune-compromised state.
结局指标
主要结局
Thyroid Stimulating Hormone
时间窗: 3 months
次要结局
- Zulewski Clinical Score(3 months)
- Thyroid Symptoms Questionnaire-TSQ(3 months)
- Thyroid-specific Patient Reported Outcome-ThyPRO(3 months)
- Free T4(3 months)
研究者
Debarsi Das
Metropolitan Homoeopathic Medical College and Hospital