Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: CALEBIN-A: One capsule of Calebin A, b.i.d, 30 min after breakfast and dinner for 90days.
Control Intervention1: Placebo: One capsule of placebo, b.i.d 30 min after breakfast and dinner
Sponsors
Sami Sabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. IDF (International Diabetes Federation) 2006: Waist � 90 cm (men) or � 80 cm (women) along with the presence of minimum two or more of the following: a. Fasting blood glucose greater than equal to 5.6 mmol/L (100 mg/dl) or diagnosed diabetes b. HDL cholesterol c. Blood triglycerides > 1.7 mmol/L (150 mg/dl) or drug treatment for elevated triglycerides d. Blood pressure > 130/85 mmHg or drug treatment for previously diagnosed hypertension. 2. Male and/or female subjects aged between 30 to 65 years (both inclusive) with valid age proof. 3. BMI (�) greater than or equal to 28 kg/m2 and less than or equal to 35 kg/m2. 4. Willing to take up regular physical activity (for example: walking for a span of 30 minutes daily for 5 days in a week). 5. Subjects willing to agree for blood draws as per the protocol. 6. Able to give written informed consent. 7. Willing to come for regular follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Intake of prescribed drugs in Ayurveda, Homeopathy, Naturopathy, Allopathy etc. or prior surgery for obesity in the previous six months 2. Pathophysiologic/genetic syndromes associated with obesity (Cushingââ?¬•s syndrome, Turnerââ?¬•s syndrome, Prader-Willi syndrome). 3. Subjects who disagree to avoid drinking alcohol during study period. 4. Subjects with diagnostic history of malignancy. 5. Fasting Blood Glucose ââ?°Â¥ 150 mg/dl and HbA1c > 7%. 6. Subjects with history of clinically diagnosed Hypertension and with BP > 160 / 100 mm of Hg. 7. Subjects diagnosed with thyroid disease, on medications for underactive or overactive thyroid and with TSH > 6 mIU/L. 8. Subjects on lipid lowering drugs. 9. Subjects having history of underlying Inflammatory arthropathy, Septic arthritis, Inflammatory joint disease, Gout, Pseudo gout, Pagetââ?¬•s disease, Joint fracture, Acromegaly, Fibromyalgia, Wilsons disease, Ochronosis, Hemochromatosis, Heritable arthritic disorder or Collagen gene mutations or Rheumatoid arthritis. 10. Subjects 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 Disorder [COPD]. 11. Have been diagnosed with an eating disorder, such as Anorexia nervosa, bulimia nervosa, Binge eating disorder or Nocturnal eating disorder. 12. History of any psychiatric disorders like Schizophrenia or Bipolar disorder. 13. Weight loss (-5%) in last 3 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. 18. Subjects who have completed participation in any other clinical trial during the last six months. 19. Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Mean change in measured body weight 2 Mean change in Fasting Blood SugarTimepoint: 1 Mean change in measured body weight (Baseline to Day 90) 2 Mean change in Fasting Blood Sugar (Baseline to Day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Mean change in serum biomarkerââ?¬â??Insulin 2 Mean change in HbA1c 3 Mean change in calculated BMI 4 Mean change in waist circumference 5 Mean change in waist to hip ratio 6 Mean changes in Lipid profile 7 Mean change in inflammatory markerââ?¬â??HsCRP 8 Mean change in blood pressure 9 Adverse events and significant change in laboratory parameters.Timepoint: 1 Serum Insulin(Baseline to Day 90) 2 HbA1c (Screening to Day 90) 3 Calculated BMI (Baseline to Day 90) 4 Waist circumference (Baseline to Day 90) 5 Waist to hip ratio (Baseline to Day 90) 6 Lipid profile (Screening to day 90) 7 HsCRP (Baseline to Day 90) 8 Blood pressure (Baseline to Day 90) 9 Adverse events and laboratory parameters. (Screening & Day 90) | — |
Countries
India
Contacts
Public ContactDr Kalpesh Shah
ClinWorld, a division of Sami-Sabinsa Group
Outcome results
None listed