Efficacy and Safety of Flabonoid in subjects with Metabolic syndrome
- Conditions
- Metabolic Syndrome
- Registration Number
- CTRI/2015/11/006366
- Lead Sponsor
- Generix Lifesciences Pvt Ltd
- Brief Summary
The study under trial is to investigate the efficacy of a novel herbal composition flabonoid which believed to be providing a solution for a condition known as metabolic syndrome. Flabonoid is a plant extract containing natural thrapeutic component known as Glabridin, a major polyphenolic flavonoid of G. glabra. The active igredient present in flabonoid is ***Kaneka glavonoid***, which has different effect on humaan body like anti- oxidative, anti- *H. pylori ,* anti- nephritic, radical scavenging activity, anti diabetic, anti-hypertensive, anti- hyperlipidemia anti-artherosclerotic and anti-obese effect. All these effects are essential to control the disorder called metabolic syndrome. So the aim of this study is to evaluate the clinical effectiveness of the flabonoid versus placebo in patient with metabolic syndrome having age relaxation between 18 to 75 , with satisfying the NCEP ATP III criteria. Enrolled subject will receive either flabonoid or placebo for 84 days.At last the effectiveness of flabonoid will be compared with placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
1 Male or female subjects between 18 to 75 years of age 2 Ability to understand the risks/benefits of the protocol 3 Female subjects of childbearing potential must be using a medically acceptable form of birth control Female subjects of non-childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy 4 Confirmed diagnosis of metabolic syndrome as per ATP-III guidelines This includes the presence of at least 3 or more of the following 5 factors (As per modified NCEP ATP III guidelines-specific for South Asia) Including Abdominal waist circumference > 90(males) >80 cm (females) And Increased blood pressure (>130/85 Hg) Serum triglycerides ≥ 150 mg/dL Serum HDL cholesterol < 40 mg/dL (males) < 50 mg/dL (females) Elevated fasting blood glucose ≥ 100 mg/dL 5 Subjects agree to maintain the activity dairy 6 If Former smoker (previously smoked ≥10 cigarettes/day for at least 1 year, cessation for at least 6 months 7 Willing to give written informed consent and willing to comply with trial protocol.
1 Pregnant or breast feeding women 2 Uncontrolled hypertension and Diabetes 3 Other cardiovascular disease or previous cardiovascular event These include a history of angina pectoris b history of heart failure c Presence of a cardiac pacemaker d History of myocardial infraction e Previous revascularization procedure 4 History of cerebrovascular disease including stroke and ischemic attack 5 Subjects having abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of normal elevated Creatinine males > 125 μmol/L females > 110 μmol/L renal insufficiency thyroid or other endocrine disease 6 Currently being treated for cancer (i e chemotherapy radiation therapy) 7 Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent 8 Any other condition that in the opinion of the investigator would adversely affect the subjects ability to complete the study or its measures 9 Patient on any medication which is known to modify signs and other parameters of metabolic syndrome 10 Hypersensitivity to any of the ingredient used in the study supplements 11 Alcohol consumption exceeding the definition of moderate drinking (2 drinks/day for men or 1 drink/day for women) 12 Subjects participated in any investigational study medication within thirty (30) days prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood Pressure Day 0 Day 28 Day 56 Day 84 Serum HDL Day 0 Day 28 Day 56 Day 84 Abdominal waist circumference Day 0 Day 28 Day 56 Day 84 Fasting blood glucose Day 0 Day 28 Day 56 Day 84 Change from Baseline to End of the study in Metabolic syndrome symptoms Day 0 Day 28 Day 56 Day 84 Serum triglycerides Day 0 Day 28 Day 56 Day 84
- Secondary Outcome Measures
Name Time Method Change from Baseline to End of the study in Serum LDL
Trial Locations
- Locations (1)
Rajiv Gandhi Institute of Medical Sciences and RIMS Govt General Hospital
🇮🇳Srikakulam, ANDHRA PRADESH, India
Rajiv Gandhi Institute of Medical Sciences and RIMS Govt General Hospital🇮🇳Srikakulam, ANDHRA PRADESH, IndiaDr V Kiran KumarPrincipal investigator91-8179547084rimsresearch@gmail.com