Comparative clinical study to evaluate the efficacy of Guduchyadi Yoga with Navak Guggulu in Medoroga w.s.r. Dyslipidaemia- a Randomized controlled 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
- Reduction in the hematological parameters of dyslipidaemia
研究概览
简要总结
The term Medoroga was first used by Acharya Madhava to define obesity and related lipid disorder. In Ayurvedic classics, in reference to “Medoroga†two types of Meda(fat) are described viz. Baddha Meda and Abaddha Meda. Baddha Meda - the fat which is not mobile and is stored in the form of fat at various places (fat depot/ omentum/ muscles in the body). Abaddha Meda - the fat which is mobile and circulates in the body along with blood in the form of lipids (cholesterol, triglycerides, LDL, HDL and VLDL). According to Madhava Nidana, Nidana of Medoroga are lack of exercise, sleeping in day time, increase intake of Kaphavardhaka Ahaar Vihaar. The person with Medo Roga will have Kshudra Shwas (breathlessness), Trishna (excessive thirst), Moha, Swapna (excessive sleep), Krathana (Sudden obstruction of breath), Sadana (looseness of the body) Kshuta (Excessive hunger), Sweda (excessive sweating), Daurgandhya (foul body smell), Alpa prana (Fatigue), Alpa Maithuna (loss of libido). Dyslipidaemia is defined as a disorder of lipoprotein metabolism, it refers to lipid abnormalities consisting of either one or any combination of elevated total cholesterol (TC), elevated triglycerides (TG), elevated low- density lipoprotein (LDL-c) or low high-density lipoprotein (HDL-c). Dyslipidaemia is one of the major health problems in both developed as well developing country and arising as a result of combination of some genetic factors, environmental factors like sedentary lifestyle, rapid urbanization, underactive thyroid gland, obesity, nutritional advancement accompanying economic development, excess alcohol intake and other associated medical conditions. In general, its prevalence increases with age. Indian Council of Medical Research (ICMR) reported a prevalence of dyslipidaemia of 37.5% among adults aged between 15 to 64 years, with an even higher prevalence of dyslipidaemia (62%) among young male industrial workers.
The present study aims to evaluate the Comparative effect of Guduchyadi Yoga with Navak Guggulu in the management of Medoroga ~ Dyslipidaemia.
the total number of patient is 60, 30 in each group
In group A, Navak Guggulu will be administered in a dose of 1 gm twice daily with warm water 1 hour after meals. In group B, Guduchyadi Yoga will be administered in a dose of 5 gm twice daily with madhu (honey) 1 hour after meals.
the design of the study is single centered, open label, Randomized comparative and interventional study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •a. Already Diagnosed cases of Dyslipidaemia based on investigation within 1 month of period. b. Subjects with any one or more Lakshana of Medoroga. c. Subjects with any one or more of the following parameter.
- •Total Cholesterol above 200mg/dl and upto 400mg/dl, Triglycerides above 150 mg/dl and upto 300 mg/dl or HDL below 40mg/dl and upto 20 mg/dl or LDL above 100mg/dl and upto 200 mg/dl or VLDL above 30mg/dl to 60 mg/dl. d. Subjects between the age group of 21-60 years of either sex. e. Subjects who are ready to give consent with firm home address and contact no. which is readily accessible during coarse of trial.
排除标准
- •Subjects with total cholesterol above 400mg/dl or Triglycerides above 300 mg/dl or LDL cholesterol above 200mg/dl or HDL cholesterol below 20mg/dl, VLDL above 60 mg/dl.
- •Subjects having Insulin dependent Diabetes Mallitus and uncontrolled DMT2 even after using OHA.
- •Subjects with uncontrolled Hypertension -BP greater than 150/90 mm of Hg. d.
- •Subjects having major systemic illness except patients of obesity, controlled DMT2, controlled patients of Hypertension.
- •Subject below 21 years and above 60 years of age.
- •History of adverse reaction to any trial drug or their ingredients.
- •Pregnant females and lactating mothers.
- •Subjects who are already registered in any other research project.
- •Subjects who are not willing for the trial.
结局指标
主要结局
Reduction in the hematological parameters of dyslipidaemia
时间窗: 90 days
Total cholesterol: Levels below 200 mg/dL
时间窗: 90 days
Triglycerides: levels below 150 mg/dL
时间窗: 90 days
LDL cholesterol: Levels below 100 mg/dL
时间窗: 90 days
HDL cholesterol: Levels above 40 mg/dL in men and above 50 mg/dL in women
时间窗: 90 days
VLDL cholesterol: levels below 30 mg/dL
时间窗: 90 days
次要结局
- Improvement in Clinical features of Medoroga(a) Kshudra Shwasa (Breathlessness))
研究者
Dr Komal Shahu
Chaudhary brahm prakash ayurved charak sansthan