Comparative study of the effect of patol amalaki churna and yava amalaki churna in sthaulya with special reference to obesity
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assessment will be done based on subjective and objective criteria
研究概览
简要总结
In today’s world, sedentary lifestyle, faulty dietary habits including ready to eat fast food and relatively less exercise and stress have made man the victim of many diseases.
Sthaulya is one of these diseases, in which there is an abnormal and excessive accumulation of Medodhatu. In medical science, Sthaulya can be compared with obesity. Obesity is one of the world’s oldest metabolic disorders. The prevalence rate of sthaulya is 16.6%.
Patol amalaki churna has been selected as a trial group A and Yava amalaki churna has been selected as a trial group B which breakdown the pathophysiology of sthaulya.
The patients within the age group of 18 to 60 years who fulfilled the clinical diagnostic criteria and had symptoms of sthaulya as mentioned in classics were selected irrespective of sex, socio – economic status and community. Written consent from patient were taken prior to the study. Computerised generated sampling technique for randomisation was used. Total 80 number of patients were selected and divided into two groups, named as trial group A (40) and trial group B (40) in which 51 patients study was completed and remaining patients study is ongoing.
Both Patol amalaki churna (trial group A) and Yava amalaki churna (trial group B) with dose 5 gm BD with anupana koshana jaal was administered to patients and observations were done on day 0, day 14, day 28, day 45 and after 56th day.
Patient enrolment in progress. Discussion, summery and conclusion will be done after statistical analysis on completion of study and will be unbiased.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.The patient having age between 18 years to 60 years and irrespective of socioeconomic status, sex and religion.
- •2.Patient having signs and symptoms of obesity mentioned in Ayurvedic classics like Swedadhikya, Kshudraswasa, Chalsphikaudarstanalumban, Atiskhudha, Angagaurav, Angachalatva, Avyavaya, Atipipasa.
- •3.The patient of Obese class I (30.0-34.9 kg/m2) and Obese class II (35.0-39.9 kg/m2) 4.Patients having dyslipidaemia in their lipid profile results.
排除标准
- •1.The patient having Uncontrolled Hypertension, Cardiovascular disease, pregnant women and will be excluded.
- •2.The patient of Obese class III (More than 40 kg/m2) will also be excluded.
- •3.Patients having serious cardiac, pulmonary, renal and hepatic disease etc.
- •4.Obesity and Hyperlipidemia due to drugs e.g. Anticonvulsant, Beta blockers, Corticosteroid and Diuretics.
- •5.Patient having history of metabolic disorders like Diabetes mellitus, etc and other Endocrine diseases.
结局指标
主要结局
Assessment will be done based on subjective and objective criteria
时间窗: After 45 days
Subjective criteria is
时间窗: After 45 days
Alasya,Kshudrashwasa,Swedadhikya,Daurbalyata,Atikshudha ,Daurgandhya
时间窗: After 45 days
will be assessed based on gradation before and after treatment.
时间窗: After 45 days
Objective criteria is
时间窗: After 45 days
1.Weight
时间窗: After 45 days
2.BMI:Body Mass Index
时间窗: After 45 days
3.Waist to Hip Ratio
时间窗: After 45 days
4.Lipid profile which will be assessed before and after treatment
时间窗: After 45 days
次要结局
未报告次要终点
研究者
Dr Vaishnavi VijayKumar Zawar
SMBT ayurved college and hospital