Health Condition 1: null- Metabolic Syndrome
Conditions
Interventions
Intervention1: Flabonoid: One capsule Once Daily to be taken orally for 84 Days
Control Intervention1: Placebo: One capsule Once Daily to be taken orally for 84 Days
Sponsors
Generix Lifesciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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 �¼mol/L females > 110 �¼mol/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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to End of the study in Metabolic syndrome symptoms Blood Pressure Serum triglycerides Serum HDL Abdominal waist circumference Fasting blood glucose Timepoint: Day 0 Day 28 Day 56 Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline to End of the study in Serum LDL Total Cholesterol Change in Body weight Assessment of body composition Change in Glycosylated haemoglobin ( HbA1c) Timepoint: Day 0 Day 28 Day 56 Day 84 | — |
Countries
India
Contacts
Public ContactMr Sanjib Kumar Panda
Ocius Life Sciences Pvt Ltd
Outcome results
None listed