A Randomized controlled clinical Trial to study the efficacy of Thyrocompound in the management of Subclinical Hypothyroidism.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effect on Weight BMI Serum TSH Total Cholesterol LDL HDL Triglycerides
研究概览
简要总结
This study is Open Randomized control parallel group trial , comparing efficacy of oral administration of Thyrocompound 1 gm per day two times after food and Tab. Levothyroxine continued as per the prescribed individualized dose empty stomach only early in the morning for 90 days in 100 patients with presentation of Subclinical Hypothyroidism , that will be conducted in Maharashtra, India. The primary outcome measures will be Weight, BMI, Serum TSH levels, LDL, HDL, Total Cholesterol at the basement of subject enrollment and 91 th day at the end of trial.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of grade 1 subclinical hypothyroidism having serum TSH level within range of 4.9 mL/L to 10 mL/L.
- •2.Patients having 3 clinical symptoms of subclinical hypothyroidism among following- tiredness weakness lethargy dry skin and hair cold intolerance loss of hairs difficulty in concentration and poor memory weight gain with poor appetite constipation hoarseness of voice dypsonea menorrhagia puffy face hands and feet bradycardia.
排除标准
- •Grade 2 subclinical hypothyroidism serum TSH level more than 10 mL/L.
- •Primary hypothyroidism caused due to thyroidectomy radioactive Iodine Therapy for Graves disease or Nodular Goiter.
- •Radio therapy for head and neck cancer.
- •Secondary hypothyroidism
- •Patients Having history of medications like Amiodarone, Interleukin -2 Kinase inhibitor and lithium
- •Patients undergoing any known hormonal therapy other than Levothyroxine
- •Patients suffering from chronic anemia
- •Co morbid patients like known case of HTN, DM, IHD, Angina , MI
- •Patients receiving anti retro viral therapy.
结局指标
主要结局
Effect on Weight BMI Serum TSH Total Cholesterol LDL HDL Triglycerides
时间窗: at Baseline and | 13 weeks of Trial.
Tiredness weight gain in last 3 months hair loss
时间窗: at Baseline and | 13 weeks of Trial.
dryness of hair and skin constipation
时间窗: at Baseline and | 13 weeks of Trial.
puffiness of face
时间窗: at Baseline and | 13 weeks of Trial.
muscle weakness
时间窗: at Baseline and | 13 weeks of Trial.
difficulty in concentration
时间窗: at Baseline and | 13 weeks of Trial.
次要结局
- Age, sex, economical Status and Prakruti of subjects will be evaluated as a secondary outcome(at the end of 13 weeks)
研究者
Dr Varsharani Arjun Chaudhari
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Nashik