An open label, prospective clinical comparative study to assess the anti-inflammatory benefit of momordica charantia tablet in metabolic syndrome.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To compare the clinical effectiveness of Momordica Charantia Tablet with Standard drug therapy in the newly diagnosed Metabolic Syndrome patients
研究概览
简要总结
Introduction: Metabolic syndrome is the combination of various abnormalities like raised blood sugar,raised blood pressure and decreased HDL cholesterol which is the major health problem that leads to cardiovascular disease.there is triple therapy regimen for the treatment and this study focus on the momordica as add on therapy which also has the property to reduce blood sugar ,blod pressure and cholesterol level inaddition to the property of reducing inflammmation.
Material and Methodology:
Sample size of 66 patients in 2 groups(33/group)will be randomly assinged through simple randomization to treat with standard drug(Olmesartan 20 mgOD,Metformin 500mgOD and Atorvastatin 10 mg OD )and momordica tablet (commercially available tablet)as add on therapy for a period of 3 months.Baseline parameters like Blood pressure,waist circumference,BMI,Body weight,FBS,PPBS,SOD,MDA,HSCRP HbA1C were done before and after the treatment
Result
Data were collected and analysed by one way ANOVA and Unpaired t test
Conculsion:
IHEC Approval
This study has been approved by IHEC of PSG INSTITUTE OF MEDICAL SCIENCE AND RESEARCH(affliated to TN MGR MEDICAL UNIVERSITY) COIMBATORE
Proposal number:19/332 dated on 6.3.2020
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients already on OLmesartan 20mg OD and Metformin 500mgOD and Atorvastatin 10 mg OD 2.Prediagnosed Metabolic syndrome patients with Diet and life style modifications 3.Age>25 years 4.Both Male and Female 5.Triglycerides>150 mg/dl 6.FBS>100 mg/dl 7.PPBS >140 mg/dl 8.BP >130/85 mmHg 9.HbA1C -5.7-6.4.
排除标准
- •1.Patients with Coronary artery disease /storke 2.Patients with Aspirin/NSAIDS/Steroid/Febuxostat/Statin/Thaizide 3.Patients with Injuries/Arthritis/Hypothyroidism/Nephrotic syndrome 4.Patients on native treatment/ayurveda/siddha treatment/on any alternative treatment 5.Pregnancy/Lactation/Heavy Alcohol Consumption 6.Blood pressure>150/100mmHg 7.HbA1C>7.4 8.Triglycerides>400 mg/dl 9.Patients on more than one drug for hypertension other than Olmesartan 20mg OD and drugs other than Metformin 500MG OD for Diabetes and drugs for elevated cholesterol other than Atorvastatin 10 mg OD.
结局指标
主要结局
To compare the clinical effectiveness of Momordica Charantia Tablet with Standard drug therapy in the newly diagnosed Metabolic Syndrome patients
时间窗: Pre Medication Parmeters -BP,Body Weight,Waist Circumference,BMI,FBS,PPBS,HbA1C,SOD,MDA,HS-CRP will be done 1 day prior to intiating Medications
次要结局
- TO IDENTIFY THE ANTI-INFLAMMATORY BENEFIT OF MOMORDICA CHARANTIA TABLET IN PATIENTS WITH METABOLIC SYNDROME USING MARKERS OF OXIDATIVE STRESS SOD,MDA,HS-CRP(POST MEDICATION PARAMETERS-BP,BMI,BODYWEIGHT,WAIST CIRCUMFERENCE,FBS PPBS,HbA1C,HS CRP,SOD,MDA AFTER 3 MONTHS OF MEDICATION 1 DAY LATER PARAMETERS WILL BE DONE)