FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/09/045790 [Registered on: 22/09/2022] Trial Registered Prospectively
Last Modified On: 18/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To evaluate efficacy of Cyperus rotundus containing Stilbenes for weight management in obese individuals. 
Scientific Title of Study   A randomized, double-blind, placebo controlled clinical trial to evaluate the efficacy and safety of an extract from Cyperus rotundus containing Stilbenes for weight management in obese individuals. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CW/109/CRP_OBES/II/JUL/22 Version No: 1.0 Dated 27 Jul 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSSVVNarasinga Rao 
Designation  MBBS.,M.D.,(Gen.Medicine), Internal Medicine 
Affiliation  Government Medical College & Government General Hospital (Old RIMSGGH) 
Address  Government Medical College & Government General Hospital (Old RIMSGGH) Research Wing, 2nd Floor, Beside FM Ward, Government General Hospital, Srikakulam-532001

Srikakulam
ANDHRA PRADESH
532001
India 
Phone  9908611119  
Fax    
Email  drnarasingaraossvv@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Shaji Paulose 
Designation  General Manager 
Affiliation  Sami-Sabinsa Group Limited  
Address  19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka.

Bangalore
KARNATAKA
560058
India 
Phone  08028397973  
Fax    
Email  shaji@clinworld.net  
 
Details of Contact Person
Public Query  
Name  Dr Alphons Philips 
Designation  Vice President 
Affiliation  Sami-Sabinsa Group Limited 
Address  19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka.

Bangalore
KARNATAKA
560058
India 
Phone  08028397973  
Fax    
Email  alphons@clinworld.net  
 
Source of Monetary or Material Support  
Sami-Sabinsa Group Limited 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka. 560058. 
 
Primary Sponsor  
Name  Sami Sabinsa Group Limited 
Address  Sami-Sabinsa Group Limited 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka. 560058. 
Type of Sponsor  Other [[Manufactures and markets phytonutrients, standardized herbal extracts and nutritional supplements]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr T V Devarajan  Apollo First Med Hospital  154, Poonamallee High Road, Kilpauk, Chennai, Tamil Nadu. 600010. Chennai TAMIL NADU
Chennai
TAMIL NADU 		 9840083737

drtvd1944@gmail.com 
DrSSVVNarasinga Rao  Government Medical College & Government General Hospital (Old RIMSGGH)  Research Wing, 2nd Floor, Beside FM Ward, Government General Hospital, Srikakulam-532001,A.P, India.
Srikakulam
ANDHRA PRADESH 		 9908611119
8942-279033
drnarasingaraossvv@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committe  Approved 
Institutional Ethics Committe- Biomedical research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  a) Test arm: Capsule containing Stilbenes (6-8%) - 500 mg [An extract from Cyperus rotundus] Each capsule contains 500 mg of Stilbenes (6-8%) and Bioperine – 5mg   One capsule twice a day (bid) after breakfast and dinner for 90 days. 
Comparator Agent  Placebo arm: Capsule of Microcrystalline cellulose – 500mg.  one capsule twice a day (bid) after breakfast and dinner for 90 days. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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 mIU/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 <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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Decrease in body weight and body mass index
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  
Outcome  TimePoints 
1. Change in Total Cholesterol, Triglycerides, LDL, HDL and VLDL
2. Change in Leptin parameter
3. Change in Apolipoprotein B level in serum
4.Change in the laboratory parameters
5.Safety by the occurrence of AE and changes in laboratory parameters. 		 1. screening to final visit.
2. Baseline to final visit.
3. Baseline to final visit.
4. screening to final visit
5. screening to final visit 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/10/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
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.
 
Close