Health Condition 1: E66- Overweight and obesity
Conditions
Interventions
Intervention1: Curcumin polysaccharides (Starmeric�®): 5gm sachet after stirring with 200ml of water should be taken once daily 15 mins before breakfast for 7 days.
Intervention2: Curcumin polysacch
Sponsors
SamiSabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and/or female subjects aged between 18 to 45 years both inclusive. 2 BMI greater than 25kg/m2 and less than 35 kg/m2 both inclusive. 3 Normal Indian eating habits (consuming mostly three main meals per day). 4 Subjects with FBS � 130mg/dl & BP 5 Hemoglobin level >11 g%. 6 Willing to continue their usual lifestyle during the study period. 7 Able to give written informed consent.
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 Any Congenital/Genetic/Pathophysiologic disease/syndrome associated with obesity. 5 History of chronic smoking (more than 2 cigarettes a day). 6 Disagree to stop drinking alcohol during the study period. 7 Coffee/Tea intake with more than 3 cups a day. 8 On-going or recent treatment for diabetes, hypertension, coronary heart disease, psychiatric conditions, Crohnââ?¬•s Disease, ulcerous colitis, chronic constipation, eating disorders, or any disease condition which interferes with ADME of the investigational product. 9 Subjects having diagnosed with thyroid disease and are on medications for underactive or overactive thyroid. 10 Subjects on lipid lowering drugs. 11 Subjects having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout. 12 Subjects having diagnosed with or on treatment for pancreatitis, lactic acidosis, hepatomegaly with steatosis, motor weakness, peripheral sensory neuropathy, psychiatric disorder, Severe Pulmonary Dysfunction (Uncontrolled Bronchial Asthma and/or Chronic Obstructive Pulmonary Disorder [COPD]. 13 History of Weight loss with more than 5% in last 6 months. 14 Subjects 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. 15 Subjects 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 of 60 or less). 16 History of hypersensitivity to any of the herbal extracts or dietary supplement. 17 Pregnant / lactating woman will not be included in the study. 18 Subjects who have completed participation in any other clinical trial during the last three months. 19 Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the mean change in Hunger/satiety till lunch as measured by Visual Analogue Scales of hunger between the arms.Timepoint: Visual Analogue Scales of Hunger - Screening Visit (-2/-3 day), Baseline Visit (Day 0), Final Visit (Day 7) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1Mean change in Satiety Hormones at different timepoints between the arms 2Mean change in Fasting blood glucose between the arms 3Mean change in Post prandial blood glucose between the arms 4Assess the efficacy of both the actives in comparison to placebo on the bowel movements and overall gastrointestinal health by mean change in Gastrointestinal Symptom Rating Scale. 5Change in calorie intake between the arms at lunch. 6Safety evaluation based on any adverse event reported or observed during the study period and any clinically significant change in vital signs and physical examination as evaluated by the investigator.Timepoint: 1Satiety Hormones at different timepoints (0, 60 & 120 mins) between the arms (Day0 & Day7) 2Fasting blood glucose between the arms (Day0 & Day7). 3Post prandial blood glucose between the arms (Day0 & Day7). 4Gastrointestinal Symptom Rating Scale (Day0 & Day7). 5Calorie intake between the arms at lunch (Day0 & Day7). 6Safety evaluation (Day0 & Day7). | — |
Countries
India
Contacts
Public ContactDr Kalpesh Shah
ClinWorld, a unit of Sami-Sabinsa Group Limited
Outcome results
None listed