To evaluate efficacy of Cyperus rotundus containing Stilbenes for weight management in obese individuals.

Completed

• Registration Number: CTRI/2022/09/045790
• Lead Sponsor: Sami Sabinsa Group Limited

Brief Summary

1] After obtaining informed consent from the subject, patients will be evaluated by assessing the physical examination, demographics, vital signs, clinical laboratory evaluations like hematology, LFT, RFT, Lipid profile, Thyroid profile, FBS, HbA1c, Urine analysis and urine pregnancy test for female with childbearing potential will be performed.

2] Male and female obese participants who meet all the Inclusion and none of the Exclusion criteria will be enrolled in the study.

3] Eligible participants will be enrolled/randomized on visit 2 and will be administered and advised to take either extract containing Stilbenes or Placebo for a period of 90 days. During visit 2 & visit 5 blood samples for analysis of biomarkers Leptin & Apo lipoprotein B will be collected

4] Participants will be allowed to consume their diet as per the dietary plans provided by the PI and food intake. General physical activity is advised to the Participants on Day 0 i.e., visit 2.

5] Patient diaries will be given to the participants, to record their daily dietary intakes and physical activities.

6] Participants will have to visit the study site on Screening (Day -5), visit 2 (Day 0), Visit 3 (Day 30), Visit 4 (Day 60), Visit 5 i.e. final visit (Day 90). Telephonic follow-up after 15 days from the last visit.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-10
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• 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.
• Self-reported lack of physical activity and lethargic lifestyle.
• Willing to take up walking exercise for a span of 30 minutes daily for 5 days in a week.
• Participants willing to follow the recommended diet throughout the study.
• Able to give written informed consent and comply with requirements of the trial.
• Ability to swallow and retain oral medications.

Exclusion Criteria

• Intake of over the counter or prescribed Allopathic/Ayurvedic/ Homeopathic/Naturopathic weight loss medications, centrally acting appetite suppressants in the past three months.
• Previous weight loss surgeries like bariatric surgery procedures (gastric bypass, sleeve gastrectomy, adjustable gastric band, biliopancreatic diversion with duodenal switch etc.).
• On other modulators like special diet, diet control, gym and yoga.
• Pathophysiologic/genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, Prader-Willi syndrome).
• 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).
• Patients with evidence of malignancy.
• 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.
• Patients on lipid lowering drugs.
• 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.
• 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].
• Have been diagnosed with an eating disorder, such as anorexia, bulimia, binge eating disorder or nocturnal eating disorder.
• History of severe psychiatric disorders like schizophrenia or bipolar disorder.
• Weight loss (±5%) in last 6 months.
• 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.
• 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).
• History of hypersensitivity to any of the herbal extracts or dietary supplement.
• 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.
• 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	1.screening to final visit Day 90. | 2. visit – 2 to final visitDay 90
2. Decrease in waist circumference, hip circumference, and waist: hip ratio (anthropometric measurements)	1.screening to final visit Day 90. | 2. visit – 2 to final visitDay 90

Secondary Outcome Measures

Name	Time	Method
1. Change in Total Cholesterol, Triglycerides, LDL, HDL and VLDL	2. Change in Leptin parameter

Trial Locations

Locations (2)

Apollo First Med Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Government Medical College & Government General Hospital (Old RIMSGGH); 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Apollo First Med Hospital

🇮🇳Chennai, TAMIL NADU, India

Dr T V Devarajan

Principal investigator

9840083737

drtvd1944@gmail.com