None listed
Conditions
Interventions
Intervention1: iSlim Herbal formulation: Dose: once daily by skipping the lunch
Dosage form: bar formulation
Route of administration: Orally
Duration: 90 days
Control Intervention1: placebo: Dose:
Sponsors
IndusViva HealthSciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult male and non-pregnant females aged 18 to 55 years 2.BMI � 25 kg/m2 to 40 kg/m2 with one or more of the metabolic risk factors (waist circumference �80 cm, fasting glucose �100 mg/dL, BP �130/85 mmHg, HDL-cholesterol 3.Able to comply with all required study procedures and schedule. 4.Able to comply and willing to follow the prescribed diet plan. 5.Willing and able to give written informed consent. 6.Subjects who agree to stop from using supplements during the study duration time 7.Subjects willing to refrain from any obesity treatment 8.Subjects willing to follow the suggested diet plan
Exclusion criteria
Exclusion criteria: 1. Participants with uncontrolled hypertension (systolic blood pressure (SBP) >180 mmHg, or diastolic blood pressure (DBP) >120 mmHg) 2. Participants with hepatic disease (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >3 x institutional upper limit of normal) or renal disease (serum creatinine >2.0 mg/dL) 3. Participants with significant cardiovascular disease or stroke 4. Participants with history of seizures 5. Endocrine disease such as hypothyroidism or Cushing syndrome 6. History or existence of neurological or psychological disease (schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, bulimia and so on) 7. Use of medication within the past 3 months that could have an effect on weight (appetite suppressant, laxative, oral steroid, thyroid hormone, amphetamine, cyproheptadine, phenothiazine or medication having an effect on absorption, metabolism and excretion). 8. A know history or present condition of allergic response to any pharmaceutical products and supplements. 9. History of weight reduction surgery, bariatric surgery and so on 10. Weight reduction > 10% within the past 6 months 11. Women in child bearing age unable to practice any form of contraception 12. Participants on herbal supplements/any other wellness product 13. History of alcohol, tobacco, substance or drug abuse 14. Subject who has participated in a clinical study within the last 30 days prior to entering this study. 15.Participants with hypersensitivity to any of the ingredients of the study products. 16. Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Primary Measurement will be the safety and tolerability of iSlim flat tummies through, 2.Laboratory Parameters Hematology, Biochemistry, liver profile, Kidney profile, Lipid Profile, Urine analysis, Fasting blood glucose, & ECG at Screening (-0 day) and end of the Study (90 day). Timepoint: Day 0 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Body Weight/BMI: The difference in mean percent loss of baseline body weight. OR, the proportion of subjects who lose at least 5 percent of baseline body weight. 2.HbA1c Activity 3.Blood Pressure 4.Fasting Blood Glucose and Serum Insulin 5.Lipid Profile 6.Waist Circumference 7.Inflammatory Biomarker: ESR & hsCRP 8.Serum biomarkers: Leptin and Ediponectin 9.Appetite measure: Simplified Nutritional Appetite Questionnaire (SNAQ) 10.Subject Photographs (day 0 and day 90) Timepoint: Day 0,Day 45 and Day 90 | — |
Countries
India
Contacts
Public ContactDr Balu kolar
Radiant Research Services Pvt Ltd
Outcome results
None listed