Efficacy of individualized homoeopathic medicines as standalone or as an add on to standard of care on symptom profile of hypothyroidism – an open label feasibility cohort multiple randomized controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Changes in symptom profile related to hypothyroidism and Quality of life in patients at of 12 months (Zulewski’s clinical score at every month, Thyroid symptom questionnaire and SF-8 Questionnaire for QOL at every follow up).
研究概览
简要总结
| Title |
Efficacy of individualized homoeopathic medicines as standalone or as an add on to standard of care on symptom profile of Hypothyroidism – an open label feasibility cohort multiple randomized controlled trial
|Short Title/ Public title
Homoeopath****ic treatment of Hypothyroid Cases
|Methodology
Cohort multiple RCT
|Study Duration
30 M0NTHS + 6 months Extension= 3 years
|Principal Investigator (PI)
Dr. Lipipushpa Debata
|Study sites
Co- investigators at the site
|CRIH, Lucknow,
Dr. Lipipushpa Debata, R. O. (H), S-3
|DDPR CRI, Noida
Dr. Harpreet Kaur, R. O. (H), S-1
|DACRRI, Kolkata
Dr. Gurudev Choubey, R. O. (H), S-3
|NHRIMH, Kottayam
Dr. K. C. Muraleedharan, A.D (H), Dr. R.S. Krishneswari, Asst. Prof.
|RRI (H), Guwahati
Dr. Liyi Karso, R. O. (H), S-2
|Co-ordinator at Hqr
Dr. Varanasi Roja, R. O. (H), S-3
|Objectives
Primary Objectives:
i) To evaluate the efficacy of individualized homoeopathic medicines as standalone or as add on to standard of care on symptom profile and quality of life of patients suffering from hypothyroidism.
|Number of Subject
Convenient sample of 200 patients (40 patients in each Centre)
|Main Inclusion Criteria
i) Patients suffering from hypothyroidism and under LT4 with TSH within normal range or <20 μIU/ml.
ii) Fresh cases of Hypothyroidism with TSH between 10-20 μIU/ml
iii) Age: 15-50 years
iv) Literate and illiterate patients able to understand hindi.
v) Patients giving written consent to participate.
|Study Product
Individualised Homoeopathic medicines according to symptom similarity. Potency and dose will be given as per homoeopathic principles.
|Duration of administration
12 months
|Statistical methodology
All analyses shall be conducted using SPSS version 20.0. The normality of the data distribution shall be assessed before undertaking any inferential statistics. For categorical and ordinal data nonparametric test will be applied. For metric or continuous data, parametric tests shall be applied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients suffering from hypothyroidism (serum TSH within normal range or ≤ 20 μIU/ml) for at least last 3 months and undergoing standard therapy, i.e. Levothyroxine sodium in personalized dosage as decided by the conventionally trained endocrinologists.
- •Fresh cases of hypothyroidism (undergoing no treatment) with Serum TSH within 10- 20 μIU/ml.
- •Age: 15- 50 years.
- •Literate and illiterate patients; ability to understand Hindi.
- •Patients giving written consent to participate.
排除标准
- •i) TSH above 20 μIU/ml ii) Patients suffering from congenital hypothyroidism iii) Patients with psychiatric diseases iv) Pregnancy and lactation v) Cases suffering from any other uncontrolled systemic illness or life-threatening infections or any vital organ failure vi) Cases already undergoing homoeopathic treatment for any chronic diseases vii) Substance abuse and/or dependence.
结局指标
主要结局
Changes in symptom profile related to hypothyroidism and Quality of life in patients at of 12 months (Zulewski’s clinical score at every month, Thyroid symptom questionnaire and SF-8 Questionnaire for QOL at every follow up).
时间窗: 12 months
次要结局
- To evaluate(a) Changes in TSH level at every 4 weeks.)
研究者
DR LIPIPUSHPA DEBATA
Under Central Council for Research in Homoeopathy Ministry of Ayush Govt of India