THE SCIENTIFIC TTILE OF THE STUDY IS- EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE VERSUS THYROIDINUM 3X IN THE MANAGEMENT OF SUBCLINICAL HYPOTHYROIDISM- A DOUBLE ARM PROSPECTIVE CLINICAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary outcome will be to reduce levels of serum TSH and bring it back within the normal range.
研究概览
简要总结
Subclinical hypothyroidism (SCH) is defined as mildly elevated thyroid-stimulating hormone (TSH) above the normal limit (0.4-4.5 mIU/L) and below that of overt hypothyroidism (<10.0 mIU/L) despite normal serum levels of free thyroxine (T4&T3).
Aim of this study is to asses the efficacy of homoeopathic medicine in normalizing the levels of TSH in subclinical cases of hypothyroidism
Objective 1. To assess change in quality of life using WHO-QOL-Bref scale in subclinical hypothyroidism. 2. To asses changes in the symptoms of subclinical hypothyroidism using Zulewski’s clinical score. 3. To find out symptoms of subclinical hypothyroidism
Hypothesis and Research question
Is there any significant difference in the levels of TSH before and after application of individualized Homoeopathy (IH) and Thyroidinum 3x on subclinical hypothyroidism? â–ª Hypothesis:
- Null hypothesis (H0): There will be no difference between individualized homoeopathy (IH) and Thyroidinum 3X in the management of subclinical hypothyroidism.
- Alternative hypothesis (HA): There will be significant difference between individualized homoeopathy (IH) and Thyroidinum 3X in the management of subclinical hypothyroidism.
Procurement of medicines: Pharmacy of Nehru Homoeopathic Medical College & Hospital.
Study duration: 12 Months
Study design : A randomized, prospective, comparative study.
Selection of samples: Cases with raised TSH and normal FT3 and FT4 levels, samples will be collected in IPD and OPD of NHMC&H
Sample Size Total 60 patients will be included in trial. 30 in Homoeopathic intervention arm and 30 in Comparator arm.
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
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients between 12 to 60 years of age and willing to participate in the study.
- •Patients with elevated levels of TSH above 4.5 mIU/L and below 10.0 mIU/L and T3, T4 within normal limits.
- •Patients with diagnosed Hashimoto’s Thyroiditis cases with TSH above average and T3, T4 within normal limits.
排除标准
- •Pregnant woman and Lactating women.
- •Patients with other severe systemic illnesses, malignant disorders, autoimmune diseases.
- •Patients below 12 years of age.
结局指标
主要结局
Primary outcome will be to reduce levels of serum TSH and bring it back within the normal range.
时间窗: Data will be collected at Baseline, after 1 month and after 3 months from the date of enrollment
次要结局
- The Secondary outcome will be changes in the Zulewski’s clinical score & WHO-QOL bref scale after application of individualized homoeopathic medicine & thyroidinum 3x.
研究者
DR YASMEEN ANSARI
Nehru Homoeopathic Medical College And Hospital