Evaluation of comparative efficacy of Mustadi Gana Vasti (Kala Vasti) versus Lekhana Vasti (Kala Vasti) in the management of Obesity (Sthoulya): A randomized clinical trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Mustadi Gana Vasti over BMI, Anthropometric measures, and Lipid Profile (Blood Cholesterol level) in patients with obesity.
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 superiority clinical trial. It will include a 48 days treatment period and at Day follow up period baseline, 16th and 48th day.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients are willing to give written informed consent 2.Patients of either sex aged between 20 and 60 years 3.A patient who is fit for Vasti 4.Primary obesity 5.The patients selected for the clinical trial were selected according to signs and symptoms of Sthoulya described in Ayurvedic texts and modern parameters 6.BMI is between 27 to 40.
排除标准
- •1.Patients suffering from pulmonary disease, Cardiac diseases, Endocrine disorders, and complicated cases were not taken for the study.
- •Patients having a BMI of more than 40 above i.e., class II, III, extremely high obesity and severe complicated cases, will be excluded.
- •2.Patients with uncontrolled type 2 diabetes.
- •3.Pregnant and lactating women.
- •4.Sthoulya with pregnancy and with other significant associated illnesses, patients taking corticosteroids, oral contraceptive pills.
- •5.Drug-induced obesity (E66.1 of ICD-10 criteria) 6.Obesity due to any secondary causes, i.e, (Endocrine causes: Hypothyroidism, Cushing’s disease), (Genetic causes: Monogenic obesity: Leptin and leptin receptor deficiency), (Syndromic obesity: Prader–Willi syndrome, Bardet-Biedl syndrome) 7.Toxicological contents are excluded from the trial group.
- •(Semecarpus anacardium, Aconitum heterophyllum).
结局指标
主要结局
To assess the efficacy of Mustadi Gana Vasti over BMI, Anthropometric measures, and Lipid Profile (Blood Cholesterol level) in patients with obesity.
时间窗: 16th and 48th day
次要结局
- To assess the efficacy of Mustadi Gana Vasti over BMI, Anthropometric measures, and Lipid Profile (Blood Cholesterol level) in patients with obesity.(16th and 48th day)
研究者
DR ADESH KRUSHNAKANT PANDAV
Mahatma Gandhi Ayurved College Hospital and Research Center