“Nidanatmaka study of Medoroga (Adiposopathy) and Upashayatmaka Randomised trial of Nyagrodhadi Ghanavati and Navaka Gugguluâ€
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1.Change in LDL-C level at the end of study
研究概览
简要总结
The objectives of this prospective cohort study (provisional sample size 200 urban patients) are (a) Generation of cross sectional data on Prakriti, body composition, presence of adipocytokines flux / hematologic markers in peripheral blood, ectopic lipid deposition, insulin resistance and clinical/biochemical parameters of diabetes, hypertension, dyslipidemia and atherosclerotic vascular disease in members of Jaipur families at high risk of T2DM. (b) application of data so generated in development of a staging system of Medoroga - dysmetabolism (adiposopathy/sick fat, allopath equivalent of Medo Roga), (c) study effect of Nyagrodhadi Ghana vati and Medohara guggulu on Medoroga -dysmetabolism (parameters of adiposopathy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with LDL-C ≥ 130(mg/dl) at the time of screening.
- •Subjects with BMI ≥24
- •Subjects willing to follow the procedures as per the study protocol and voluntarily give written informed consent.
排除标准
- •Subjects with Diabetes Mellitus Type I and uncontrolled Diabetes Mellitus Type II.
- •Subjects with uncontrolled Hypothyroidism or Hyperthyroidism
- •Known cases of Severe/Chronic Hepatic or Renal disease
- •Known subject of any active malignancy.
- •Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
- •Known case of Anorexia Nervosa or Bulimia nervosa
- •Chronic alcoholics / Alcohol Abuse
- •Subjects ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
- •Subjects X- ray chest showing any active lesion of tuberculosis
- •Subjects having known chronic, contagious infectious disease, such as active tuberculosis Hepatitis B or C, or HIV.
- •Subjects using any other investigational drug within 1 month prior to recruitment
- •Known hypersensitivity to any of the ingredients used in study drug
- •Pregnant and Lactating females.
- •Subjects currently participating in any other Clinical study
- •Any other medical or surgical condition considered unsuitable for subject participation in the study as per Investigator’s judgment.
结局指标
主要结局
1.Change in LDL-C level at the end of study
时间窗: Baseline, 6th Week, 12th Week
2.Change in body weight at the end of study
时间窗: Baseline, 6th Week, 12th Week
次要结局
- 1.Change in LDL-C level at 6 weeks(2.Change in other lipid parameters such as Triglycerides (TG), Total Cholesterol (TC) and High Density Lipoprotein (HDL) at 6 weeks and 12 weeks.)