None listed
Conditions
Interventions
Intervention1: INDUS810 Capsules: two capsules to be taken once daily in the morning, before meal (empty stomach) for 12 weeks
Control Intervention1: PLACEBO Capsules: No active pharmaceutical ingred
Sponsors
Indus Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.2. Women with age between 18 to 60 years 3. Healthy females with body mass index (BMI) of 25 to 30 kg per m2 4. Willing to continue with their existing diet, exercise, and lifestyle habits throughout the study, without any change.5. Agree to avoid consuming any supplements meant for weight or fat loss during the study period.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded from the study: 1. Allergy or sensitivity to any ingredient of investigational product 2. Participation in any clinical study within 30 days before randomization. 3. Use of natural health products or dietary supplements within 7 days before randomization and during the study. 4. Pregnant or planning to be pregnant and lactating. 5. Any kind of substance abuse, (alcohol, tobacco, or any other substance). 6. Participant taking cholesterol lowering medications, for eg. Statins like atorvastatin, Fibrates like fenofibrate 7. Participant with a history of hyper or hypo thyroidism and currently taking hyper or hypo thyroid medicines. 8. Uncontrolled metabolic diseases or chronic diseases at the discretion of the investigator 9. Unstable medical conditions as determined by the qualified investigator. 10. Planned surgery during the trial; history of any surgery past 3 months. 11. Current diagnosis of immune-compromised conditions like HIV or AIDS, cancer 12. History of blood or bleeding disorders; blood donation in the previous 2 months. 13. Any other condition that in the qualified investigator’s opinion may have adversely affected the participant’s ability to complete the study or its measures or which may have posed a significant risk to the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of INDUS810 oral supplementation (Capsules) on percent fat mass as measured by DEXATimepoint: Baseline, Week 6, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| A: Efficacy 1. Total body mass composition:Absolute fat mass,Lean mass,BMC,Fat-free mass,Body weight,Total tissue mass 2. Visceral adipose tissue Segmental body composition through tissue percent fat, region percent fat, tissue mass,fat mass,lean mass,BMC,total mass in Arms, Legs, Trunk, Android, Gynoid,Android to Gynoid ratio,Total,Fat mass ratio 4. Total BMD 5. Resting Metabolic Rate 6. Relative skeletal muscle mass index 7. Anthropometric measures:Waist circumference,Hip circumference,Waist-hip ratio,Abdominal girth 8. BMI 9. Fatty Liver Index 10. NAFLD liver fat score & fat percent 11. Dose and frequency of ongoing medication taken for fat mass related co-morbidities. 12. LFT 13. Lipid & carbohydrate metabolism parameters 14. Phenotypic Age 15. Physical activity: 6-MWT, 30-sec chair stand test 16. Quality of life:SF-36 B. Safety: 1. Clinical examination 2. Vital signs 3. hematology,KFT,urine analysis 4.Adverse eventsTimepoint: Baseline, Week 6, Week 12 | — |
Countries
India
Contacts
Public ContactMr Sohal Pendse
ProRelix Services LLP
Outcome results
None listed