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CTRI Number  CTRI/2025/12/098378 [Registered on: 03/12/2025] Trial Registered Prospectively
Last Modified On: 07/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical trial on reducing body fat in overweight adults 
Scientific Title of Study   A randomized, double-blind, placebo-controlled, parallel group, single center clinical trial to assess the efficacy and safety of vine tea extract versus placebo for body fat loss in overweight subjects 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
DH/VineTea/Obesity/2024 Dated: 15 May 2024   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Reginald Varadarajulu 
Designation  Principal Investigator 
Affiliation  Medstar Speciality Hospital  
Address  Department of General Medicine, 2nd floor, Kodigehalli Main Road, Sahakarnagar, Bangalore 560092 Karnataka, India.

Bangalore
KARNATAKA
560092
India 
Phone  9884457106  
Fax    
Email  varadarajuludr.medstar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shubarani M 
Designation  Head Medical Services 
Affiliation  Bangalore Clinical Services  
Address  Novel Tech Park #46/4, Ground floor, Hosur Road, Kudlu Gate Bengaluru-560 068 Karnataka, India.

Bangalore
KARNATAKA
560068
India 
Phone  9449453674  
Fax    
Email  clinical@bangaloreclinicalservices.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubarani M 
Designation  Head Medical Services 
Affiliation  Bangalore Clinical Services  
Address  Novel Tech Park #46/4, Ground floor, Hosur Road, Kudlu Gate Bengaluru-560 068 Karnataka, India.

Bangalore
KARNATAKA
560068
India 
Phone  9449453674  
Fax    
Email  clinical@bangaloreclinicalservices.com  
 
Source of Monetary or Material Support  
Daehan chemtech B-1208, 65, Gwacheon-daero 7-gil Gwacheon-si, Gyeonggi-do, South Korea - 13840 
 
Primary Sponsor  
Name  DAEHAN CHEMTECH CO LTD  
Address  B-1208, 65, Gwacheon-daero 7-gil Gwacheon-si, Gyeonggi-do, South Korea - 13840 
Type of Sponsor  Other [Nutraceutical Supplement Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Reginald Varadarajulu  Medstar Speciality Hospital  Departement of general medicine, 2nd floor, Kodigehalli Main Road, Sahakarnagar, Bangalore 560092 Karnataka, India.
Bangalore
KARNATAKA 		 09884457106

varadarajuludr.medstar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medstar Speciality Hospital Etics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E663||Overweight,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Dose: 600mg Dosage form: Tablets Route of administration: Orally Frequency: Two tablets orally in the morning before breakfast for a total daily dose of 1,200 mg Duration:84 Days 
Intervention  Vine tea extract  Dose: 600mg Dosage form: Tablets Route of administration: Orally Frequency: Two tablets orally in the morning before breakfast for a total daily dose of 1,200 mg Duration:84 Days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details   1. Subjects aged between 18 and 60 years.
 2. Body mass index BMI ranging between 25 to 32. 
 3. Subjects failing to control their body weight through diet therapy alone.
 4. Subjects willing to follow the medication diet and exercise requirements as determined by the investigators. 
 5. Subjects with stable body weight patient reported body weight change less than 5 kg in the last 3 months. 
 6. Capacity and willingness to provide written informed consent and adhere to the study protocols. 
 
ExclusionCriteria 
Details  1. Subjects who have received any medications or dietary supplements for weight reduction or management within 1 month prior to screening.
2. Subjects who have received GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, or insulin therapy within 3 months prior to screening.
3. Subjects who are pregnant, intending to become pregnant during the study period or are lactating. 
4. Subjects who are participating in any rigorous exercise programs.
5. Subjects with a history of substance abuse including drugs and alcohol.
6. Subjects with type 1 diabetes or secondary diabetes.
7. Subjects with fasting blood glucose levels greater than 126 mgdL or who are currently on any antidiabetic medications.
8. Subjects with acute metabolic complications, such as diabetic ketoacidosis or hyperglycemic coma, within 6 months before screening.
9. Subjects with obesity caused by endocrine diseases, such as Cushings syndrome.
10. Subjects with abnormal thyroid-stimulating hormone (TSH) levels.
11. Subjects with thyroid nodules of unknown etiology at the time of screening, considered clinically significant by the investigator.
12. Subjects with a past or family history of medullary thyroid carcinoma (MTC) (grandparents, parents, siblings) or multiple
endocrine neoplasia type 2 (MEN2).
13. Subjects with creatinine levels greater than twice the upper limit of normal.
14. Subjects with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than three times the upper
limit of normal.
15. Subjects with a history of pancreatic cancer or acute or chronic pancreatitis, or with acute or chronic pancreatitis at the time of screening.
16. Subjects with acute gallbladder disease (e.g., cholecystitis, gallstones) more than twice in the 1 year before screening.
17. Subjects with severe gastrointestinal disorders affecting food intake.
18. Subjects with medical conditions known to impact serum lipid levels.
19. Subjects with uncontrolled hypertension, defined as systolic blood pressure greater than 160 mmHg or diastolic blood pressure 100 mmHg.
20. Subjects with a history of binge eating behaviour, characterized by consuming a large amount of food in a short period of time with a sense of loss of control.
21. Subjects with any central nervous system disorder impeding exercise capability.
22. Subjects with major depressive disorder (MDD), anxiety disorder, or other mental illnesses at the time of screening.
23. Subjects with any musculoskeletal disorders preventing participation in exercise.
24. Subjects who have treated or plan to treat obesity with surgery or body weight loss devices during the trial.
25. Subjects with recent participation in any obesity program within the past 3 months.
26. Subjects intending to participate in another clinical study within the next month.
27. Subjects who have lost more than 5percent of their body weight in the  preceding 3 months.
28. Subjects with any serious systemic diseases as determined by the investigator or other diseases believed by the investigator to potentially interfere with the results of this study or abnormal laboratory tests with clinical significance.
29. Subjects who, according to the opinion of investigators, are not suitable to participate in clinical trials including those who are physically or psychologically unable to comply with the protocol.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Primary Outcomes:
Total body fat mass and body fat ratio through DEXA
scan (Dual Energy X-ray Absorptiometry)  		 Day 0 to Day 84  
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcomes:
1. Lean body mass through DEXA scan
2. Regional fat distribution, including fat mass in the
trunk region, android region, gynoid region, legs, and
arms through DEXA scan
3. Resting metabolic rate through DEXA scan
4. Visceral fat area, total abdominal fat area,
subcutaneous fat area, visceral-subcutaneous fat area
ratio through DEXA scan
5. Laboratory parameters (serum biomarkers)
o Serum leptin
o Serum adiponectin
6. Biochemical parameters
o Serum lipid profile (Total cholesterol, HDL
cholesterol, LDL cholesterol, Triglycerides)  		 Day 0 to Day 84  
1. Body weight
2. BMI (Body mass index)
3. Waist circumference
4. Hip circumference
5. Waist-hip ratio
6. Thigh circumference
7. Mid-upper arm circumference 		 Day 0, Day 42, and Day 84  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Obesity is a highly prevalent non-communicable disease with significant public health implications. Obesity has been recognized since ancient times, but over time, it has been interpreted varyingly depending on the science and society of the period. Obesity is described as a “multi-metabolic and hormonal disease state.” The increasing prevalence of obesity is a global health concern due to its association with higher risks of cardiovascular diseases, diabetes, and cancers. The interaction between global food systems and local environmental and genetic factors leads to significant variation in obesity prevalence across populations. In low-income countries, obesity primarily affects middle-aged adults, while in high-income countries, it affects both sexes and all age groups. The rise in obesity rates imposes a substantial health and economic burden worldwide. Projections suggest that by 2030, overweight and obesity rates will reach 89% in males and 85% in females, leading to significant increases in the prevalence of coronary heart disease, cancers, and type 2 diabetes, and escalating healthcare costs.

Vine tea extract contains multiple natural flavonoids with a wide range of biological effects on different tissues in the body. It has been extensively researched for its potential in the treatment of various conditions. Additionally, vine tea extract has demonstrated potential as a weight lowering agent in laboratory animals. The present study is designed to evaluate the efficacy and safety of vine tea extract in individuals who are mildly overweight with the study title—“ A randomized, double-blind, placebo-controlled, parallel group, single center clinical trial to assess the efficacy and safety of vine tea extract versus placebo for body fat loss in overweight subjects.
 
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