None listed
Conditions
Interventions
Intervention1: KiOnutrime- CsG capsules: One capsule of KiOnutrime- CsG capsules 15 minutes before breakfast and two capsules of KiOnutrime- CsG capsules 15 minutes before lunch and dinner, each time
Sponsors
Corona Remedies Pvt Ltd
KitoZyme
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female subjects with 18 – 65 years of age (both inclusive). 2.Subject/legally acceptable representative (LAR) of subject willing to sign and date written informed consent to participate in the study. However, if the subject/LAR of subject is illiterate, the impartial witness will sign the ICF. 3.Subjects with BMI of 26 to 35 (both inclusive). 4.Subject has clearly visible fat on intended treatment area(s), which in the investigators opinion, may benefit from the treatment(s). 5.Willingness to comply with the study schedule and procedures.
Exclusion criteria
Exclusion criteria: 1.Subject has history of surgical procedure(s) in the area of intended treatment in the past 6 months. 2.Subject has history of invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past one year. 3.Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past one month. 4.Subject on stable dose of metformine, pioglitazone or on glucagon-like peptide analogues. 5.Subject has a history of bleeding disorder or is taking any medication that in the investigators opinion may increase the subjects risk of bruising. 6.Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion. 7. Subjects with the history of allergy to chitosan or other similar molecule. 8. Subject with treatment of fat soluble vitamins and minerals or other dietary aids. 9.Subjects with uncontrolled Diabetes Mellitus (HbA1c > 10%) 10. Subjects with uncontrolled Hypertension ( > 160 / 100 mm Hg) 11. Subjects on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, anticoagulants or any other drugs that may have an influence on the outcome of the study. 12. Subject have inflammatory diseases of the gastrointestinal tract (e.g. acid reflux disease, gastritis, ventricular or duodenal ulcers, Crohn’s disease, ulcerative colitis, diverticulitis), signs of intestinal obstruction (impending or existing mechanical or paralytic ileus), gastroparesis in diabetics with neuropathy, intestinal polyps and existing severe digestive disorders (constipation). 13. Subject is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period, or is breast feeding or in preparations used in the treatment of menopause disorders. 14. Participation in any other clinical trial during last 30 days. 15. Subject is taking or has taken diet pills or supplements within the past 30 days. 16. Alcoholics and/or drug abusers. 17. Smoking or Consumption of tobacco products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of body weight on day 45 and 90 versus baseline.Timepoint: Day 45 to 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Mean change in body fat, muscle mass, bone mass, BMI, visceral Fat. • Mean change in lipid profile. • Mean change in HbA1c level • Change in upper abdominal circumference, hip circumference, waist circumference and waist: hip ratio. • Change in quality of life – SF-36 scale.Timepoint: Day 45 to 90 | — |
Countries
India
Contacts
Public ContactMr Tejas Kothari
Ethicare Clinical Trial Services
Outcome results
None listed