A Randomized Open-Labelled Controlled Clinical Study to Evaluate The Efficacy of Guduchyadi yoga In The Management Of Medoroga With Special Reference to Dyslipidemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in Serum Lipid Levels
研究概览
简要总结
The study, “A randomized controlled parallel groupclinical study to evaluate the efficacy ofGuduchyadi yoga in the management of Medoroga w.s.r to Dyslipidemia” was undertaken to manage Dyslipidemia through Ayurveda as it has a high prevalence allover world and in India. It is alsoidentified as a potential risk factor for many life-threatening diseaseslike ischemic heart diseaseand stroke.
The dissertation was made into two parts. The initialpart of the dissertation deals with reviewof literature comprising of Nirukthi,Paribhasha, Nidana, Roopa and Chikitsaof Medoroga. It also includes incidence of dyslipidemia, lipidmetabolism, classification, clinicalfeature and Management of Dyslipidemia. The later part includes materials and methods,observation, result, discussion on observation and results, conclusion and summary.
The trial was registered prospectively in CTRI on10/05/2023 with CTRI number:CTRI/2023/05/052460. The present study was completed with 30 subjects in2 groups- Trial group (Group A) and Controlgroup (Group B). Each Group had 15 subjects selectedrandomly. Subjects in Group A were treatedGuduchyadi yoga. Coarse powdersof Guduchi, Triphala,along with shodhita purana guggulu, was procured from GMP CertifiesPharmacy. 24g of kwatha churna was added to 400ml of water and boiled inopen vessel until it was reduced to 50ml, to this 1.5 grams of shodhitapurana guggulu was added to prepare Guduchyadi Yoga. Subjects ingroup B were treated with Navaka guggulu whichwas procured from GMP certified pharmacy.
The interventions were administered for a span of 30 days. Assessment was done on 0th day, 30th day and 45th day. Assessment was done on basis of objective parameters. Objective parameters wereserum lipid levels. Additionally, efficacy on weight and BMI of thesubjects were also assessed.
Statisticalanalysis for the above parameters was done using the Unpaired t-test, Repeatedmeasures of ANOVA, Paired t-test, Mann Whitney U Test, Friedman test, andWilcoxon Sign rank test.
Oncomparing the results between the groups showed statistically non-significantresults on majority of parameterssuggesting that, both Guduchyadi churna andNavaka guggulu had equal effect in themanagement of medoroga.
However, based on effect size, oraladministration of the trial drug Guduchyadi Yoga ismore efficacious than the control drug Navaka Gugguluin the management of Dyslipidemia.
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
- •Subjects who fulfill the diagnostic criteria- subjects will be diagnosed based on serum lipid profile- with increased levels of any of the serum lipids- Total cholesterol >200mg/dL LDL >129mg/dL Triglycerides ≥150mg/dL HDL ≤40mg/dL VLDL ≥30mg/dL
- •Both Obese and non-obese subjects will be included.
排除标准
- •Pregnant and lactating women.
- •Subjects with any uncontrolled systemic illness including Diabetes Mellitus and Hypertension.
- •Subjects who are on any medication for Dyslipidemia.
- •Subjects with any other condition interfering with the course of disease and treatment.
- •Subjects with any of the following Serum Lipid Levels- Total cholesterol >400mg/dL LDL >189mg/dL Triglycerides >400mg/dL HDL >40mg/dL VLDL >100mg/dL.
结局指标
主要结局
Reduction in Serum Lipid Levels
时间窗: 0th day | 30th day | 45th day
次要结局
未报告次要终点
