A Comparative Study to Evaluate the Efficacy of Punarnavadi Kwath and Navaka Guggulu in Medoroga (obesity)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1) Chala Sphika Udara Stana
研究概览
简要总结
Medoroga means a disease in which Medo dhatu is deranged and known as Medo dushti. Main involving Dosha and Dushya in Medoroga Samprapti are Kapha Dosha and Medo dhatu which leads to Medovaha Sroto dushti.It occurs due to lack of physical exercise ,sleeping day time and intake of kapha increasing diet are converted into sneha (fatty acids) which leads to increase of fat,since the increased meda blocks channels and other dhatus are not properly nourished as a result fat is further increased and the person become incapable of daily routine activities efficiently. Due to exceesive increase in Meda and Mamsa the person’s buttocks,belly and breasts become pendulous and his vigour is depleted. Medoroga may be correlated with obesity in modern medical science.
Obesity is abnormal or excessive fat accumulation that may impair health .Overweight is a BMI greater than or equal to 25 kg/m2 and a BMI greater than or equal to 30 kg/m2 is defined as obesity.
This study is aimed to compare the efficacy of Punarnavadi kwath and Navaka Guggulu in reduction of BMI and Lipid profile. total number of Patients is 80 .40 in each group .In group A , punarnavadi kwath orally 40ml twice a day empty stomach in morning and 4 hours after lunch , In group B Navaka Guggulu orally 2 tab twice a day ,1 hour after meals in morning and evening.
Criteria for Assessment-1)Subjective Parameters - Scoring Pattern will be adopted to obtain the percentage relief for sign and symptoms of Medoroga to assess the efficacy of therapy.
2)Objective Parameters-Weight, BMI scale, Waist circumfrence ,Hip Circumference, Waist Hip Ratio, Lipid Profile.
Lab investigations- Lipid profile ,it includes Serum Total Cholesterol, S. Triglycerides, S. LDL, S.VLDL, S.HDL .
Expected Outcome variables -Reduction in weight, BMI, Waist circumference , Hip circumference ,Waist Hip Ratio,, Serum VLDL,S. LDL,S. Triglycerides,S. Total Cholesterol and an increase in Serum HDL. Reduction in percentage relief in subjective criteria of Medoroga.
Statistical Analysis- by Z test and other tools as per requirement at the end of study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •BMI ranging from 30 to 40 kg/m2 2)Patient having few or more of the clinical features of Medoroga.
- •Short (repeated) breathing -Thirst -Delusions -Sleepiness -Suddden obstruction to breath -Laxity of the body -Excessive Hunger and Sweating -Foul Odour of the body -Decreased Vitality -Decreased Sexual Power of the Body 3)Patient willing to partcipate and provide signed informed consent.
排除标准
- •Patients reporting with known case of serious renal,hepatic and cardiac anomalies.
- •pregnant and lactating women 3)patients having any malignancy 4)patients who are not willing to participate with study.
结局指标
主要结局
1) Chala Sphika Udara Stana
时间窗: Day 1 | Day 15 | Day 30 | Day 45
Reduction in Scoring Patterns of sign and sypmtoms of Medoroga.
时间窗: Day 1 | Day 15 | Day 30 | Day 45
2)Alasya/Utsah hanilack of Zest)
时间窗: Day 1 | Day 15 | Day 30 | Day 45
3)Kshudra Shwasa(Difficulty in Breathing)
时间窗: Day 1 | Day 15 | Day 30 | Day 45
4)Daurbalya(weakness)
时间窗: Day 1 | Day 15 | Day 30 | Day 45
5)Nidra adhikya(Excessive Sleeping)
时间窗: Day 1 | Day 15 | Day 30 | Day 45
6)Swedadhikya(Excessive sweating)
时间窗: Day 1 | Day 15 | Day 30 | Day 45
7)Daurgandhya(Bad Odour)
时间窗: Day 1 | Day 15 | Day 30 | Day 45
8)Snigdhangata(oil lustre of body)
时间窗: Day 1 | Day 15 | Day 30 | Day 45
9)Atipipasa(Excessive Thirst)
时间窗: Day 1 | Day 15 | Day 30 | Day 45
10)Atikshuda(Excessive Hunger)
时间窗: Day 1 | Day 15 | Day 30 | Day 45
11)Angagaurava(Heaviness of body)
时间窗: Day 1 | Day 15 | Day 30 | Day 45
次要结局
- Reduction in weight,BMI,Waist circumference,Hip Circumference,Waist Hip Ratio,Serum Reduction in weight,BMI,Waist circumference,Hip Circumference,Waist Hip Ratio,Serum VLDL,S.LDL,S.Triglycerides,S.Total Cholesterol,and an increase in Serum HDL(Day 1)