evaluation of comparative efficacy of lekhan basti with ushkadi gana versus lekhan basti with triphala gana as against standard control in management of dyslipidemia (medoroga)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- reduction in triglyceride and Total Cholesterol
研究概览
简要总结
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a Randomized open labelled Standard controlled equivalence clinical trial. It will include a 48 days treatment period and at Day follow up period 0th, 16th and 48th day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are willing to give written informed consent Patients aged between 20 to 60 years Newly diagnosed dyslipidemia patient with Serum cholesterol 200 mg per dl 239 mg per dl Serum triglycerides 150 mg per dl 199 mg per dl Serum HDL more than 60 mg per dl Serum LDL more than 159 mg per dl Serum VLDL 30 mg per dl Patient fit for Basti Patient BMI between 24 point 9 kg per m2 to 30 kg per m2 Patient with controlled hypertension Patient with controlled type II DM fasting 100 to 130 mg per dl PP 140 to 180 mg per dl.
排除标准
- •Patient with known cases of Cancer tuberculosis cardiac disorders thyroid disorders uncontrolled hypertension hemorrhoids fissures any other rectal disease etc Patients Ayogya for Niruha Basti were excluded from the study Patient with uncontrolled type 2 diabetes Pregnant and lactating women Patients with addictions like drugs or drinks smoking and alcohol.
结局指标
主要结局
reduction in triglyceride and Total Cholesterol
时间窗: at baseline 0 16day 48day
次要结局
- Comparison between the reduction in Triglyceride & Cholesterol(at baseline 0 2weeks 6weeks 4 days)
研究者
Dr Samiksha Someshwar Satone
Mahatma Gandhi Ayurvedic College Hospital and Research Centre