None listed
Conditions
Interventions
Intervention1: Forslean: 250mg Capsule- Twice a day, 30 mins before breakfast and dinner for 90 days.
Control Intervention1: Microcrystalline Cellulose: 250mg Capsule- Twice a day, 30 mins before brea
Sponsors
Sami-Sabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female participants whose age =18 and = 50 years. 2. Participants must provide written and signed informed consent and comply with the requirements of the study. 3. Must be able to swallow oral medications for 90 days on a daily basis and comply with the study requirements as per the protocol. 4. Participants with a BMI of = 25 to = 29.9. 5. Self-reported lack of physical activity and lethargic lifestyle. 6. Participants who are willing to take up walking exercise for a span of 30 minutes daily for 5 days a week. 7. Participants who are willing to follow the recommended calorie intake of 2000 for women & 2500 for men throughout the study.
Exclusion criteria
Exclusion criteria: 1. Intake of over the counter or prescribed Allopathic/Ayurvedic/ Homeopathic/Naturopathic weight loss medications, centrally acting appetite suppressants in the past three months. 2. Previous weight loss surgeries like bariatric surgery procedures (gastric bypass, sleeve gastrectomy, adjustable gastric band, biliopancreatic diversion with duodenal switch etc.) 3. On other modulators like special diet, diet control, gym, and yoga. 4. Pathophysiologic/genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, Prader-Willi syndrome). 5. History of chronic smoking (more than 2 cigarettes a day) 6. Alcoholics (Inability to control drinking due to both physical & emotional dependence on alcohol characterized by uncontrolled drinking & preoccupation with alcohol). 7. Patients with evidence of malignancy 8. Patients with diabetes (Type I or Type II), FBS = 126 mg/dl and HbA1c > 6.5% 9. Patients with Hypertension having BP > 140 / 90 mm of Hg. 10. Patients diagnosed with thyroid disease, on medications for underactive or overactive thyroid and with TSH > 6 µIU/L 11. Patients on lipid lowering drugs. 12. Patients having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout, Paget’s disease, joint fracture, acromegaly, fibromyalgia, Wilsons disease, Ochronosis, hemochromatosis, heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis. 13. Patients having history of coagulopathies, cardiovascular diseases, congestive heart failure, pancreatitis, lactic acidosis, hepatomegaly with steatosis, motor weakness, peripheral sensory neuropathy, psychiatric disorder, Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]. 14. Have been diagnosed with an eating disorder, such as anorexia, bulimia, binge eating disorder or nocturnal eating disorder. 15. History of severe psychiatric disorders like schizophrenia or bipolar disorder. 16. Weight loss (±5%) in last 6 months. 17. Patients on prolonged ( > 4 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 18. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and/or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) >2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL for females or >1.4 mg/dL for males and EGFR 19. History of hypersensitivity to any of the herbal extracts or dietary supplements. 20. Pregnant/lactating women and those not willing to follow a reliable and effective contraceptive measure during the study. 21. All females with history of PCOS (Poly Cystic Ovary Syndrome) 22. Those who have participated in any other clinical trial within three months from the screening. 23. Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess mean change in body weight 2. To assess mean change in BMI 3. To assess mean change in waist circumference 4. To assess mean change in hip circumferenceTimepoint: 1. Screening to Day-90 2. Screening to Day-90 3. Screening to Day-90 4. Screening to Day-90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the change in lean body mass. 2. To assess mean change in Lipid profile 3. To assess change in visceral fats, subcutaneous fat, and total fat area using CT abdomen. 4. To assess change in biomarkers (Leptin & Adiponectin) 5. Self-reported improvement in physical activity, stamina and lifestyle based on quality of life.Timepoint: 1. Screening to Day-90 2. Screening to Day-90 3. Randomization and Day-90 4. Randomization and Day-90 5. Randomization to Day-90 | — |
Countries
India
Contacts
Public ContactSatish G
Sami Sabinsa Group Limited
Outcome results
None listed