To evaluate efficacy of Cyperus rotundus containing Stilbenes for weight management in obese individuals.
- Conditions
- Health Condition 1: -
- Registration Number
- CTRI/2022/09/045790
- Lead Sponsor
- Sami Sabinsa Group Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Male and/female participants age between 21 to 55 years
2. BMI (>=) greater than or equal to 30 kg/m2 and less than or equal to (<=) 40 kg/m2.
3. Self-reported lack of physical activity and lethargic lifestyle.
4. Willing to take up walking exercise for a span of 30 minutes daily for 5 days in a week.
5. Participants willing to follow the recommended diet throughout the study.
6. Able to give written informed consent and comply with requirements of the trial.
7. Ability to swallow and retain oral medications.
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 (Cushingâ??s syndrome, Turnerâ??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 mIU/L.
11. Patients on lipid lowering drugs.
12. Patients having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout, Pagetâ??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 <60).
19. History of hypersensitivity to any of the herbal extracts or dietary supplement.
20. Pregnant / lactating woman
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Decrease in body weight and body mass index <br/ ><br>2. Decrease in waist circumference, hip circumference, and waist: hip ratio (anthropometric measurements)Timepoint: 1.screening to final visit Day 90. <br/ ><br>2. visit â?? 2 to final visitDay 90
- Secondary Outcome Measures
Name Time Method 1. Change in Total Cholesterol, Triglycerides, LDL, HDL and VLDL <br/ ><br>2. Change in Leptin parameter <br/ ><br>3. Change in Apolipoprotein B level in serum <br/ ><br>4.Change in the laboratory parameters <br/ ><br>5.Safety by the occurrence of AE and changes in laboratory parameters.Timepoint: 1. screening to final visit. <br/ ><br>2. Baseline to final visit. <br/ ><br>3. Baseline to final visit. <br/ ><br>4. screening to final visit <br/ ><br>5. screening to final visit