| CTRI Number |
CTRI/2025/01/079489 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| 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 body fat loss in overweight subjects |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled, parallel group, single center clinical trial to assess the efficacy and safety of Terminalia bellirica extract versus placebo for body fat loss in overweight subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DH/TB/Obesity/2024 Version 1.0 dated 08th October 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suma D |
| Designation |
Principal investigator |
| Affiliation |
The Oxford Medical College, Hospital & Research Centre |
| Address |
The Oxford Medical College, Hospital & Research Centre
Professor, Department of General Medicine Room No: 1
Hosur Road (NH-)Yadavanahalli, Attibele Hobli Anekal Taluk , Bangalore Karnataka India
Bangalore
KARNATAKA
562107
India |
| Phone |
7204486097 |
| Fax |
|
| Email |
sumadasaraju.85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijendra R |
| Designation |
Head-Medical services |
| Affiliation |
Bangalore Clinical Services |
| Address |
Novel Tech Park No 46/4 Ground floor, Hosur Road, Kudlu Gate
Bengaluru-560 068 Karnataka, India.
Bangalore
Bangalore
KARNATAKA
560 068
India |
| Phone |
9980033334 |
| Fax |
|
| Email |
clinical@bangaloreclinicalservices.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijendra R |
| Designation |
Head-Medical services |
| Affiliation |
Bangalore Clinical Services |
| Address |
Novel Tech Park No 46/4 Ground floor, Hosur Road, Kudlu Gate
Bengaluru-560 068 Karnataka, India.
Bangalore
KARNATAKA
560 068
India |
| Phone |
9980033334 |
| Fax |
|
| Email |
clinical@bangaloreclinicalservices.com |
|
|
Source of Monetary or Material Support
|
| Daehan chemtech co., Ltd.
B-1208, 65, Gwacheon-daero 7-gil
Gwacheon-si, Gyeonggi-do 13840, South Korea
|
|
|
Primary Sponsor
|
| Name |
Daehan chemtech co., Ltd. |
| Address |
B-1208, 65, Gwacheon-daero 7-gil Gwacheon-si, Gyeonggi-do 13840, South Korea |
| Type of Sponsor |
Other [Nutraceutical supplement company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSuma D |
The Oxford Medical College, Hospital & Research Centre |
The Oxford Medical College, Hospital & Research Centre
Professor, Department of General Medicine Room No: 1
Hosur Road (NH-)Yadavanahalli, Attibele Hobli Anekal Taluk , Bangalore Karnataka India
Bangalore
KARNATAKA |
7204486097
sumadasaraju.85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe- The Oxford Medical College, Hospital & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Dose: 500mg Dosage form: Capsule Route of administration: Oral Frequency: One capsule orally in the morning before breakfast Duration:84 Days |
| Intervention |
Terminalia bellirica extract |
Dose: 500mg
Dosage form: Capsule
Route of administration: Oral
Frequency: One capsule orally in the morning before breakfast
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 or equal to 126 mg/dL 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 greater than 100 mmHg.
20. Subjects with a history of binge eating behavior, 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 5% 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 |
Change in the following parameters from baseline to end of treatment (Day 0 to Day 84)
Total body fat mass and body fat ratio through DEXA scan (Dual Energy X-ray Absorptiometry)
|
Day 0 and Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in the following parameters from baseline to end of treatment (Day 0 to Day 84)
1. Lean body mass through DEXA scan
2. Regional fat distribution, including fat mass in the trunk region, android region, gynoid region, legs, & 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)
a) Serum leptin
b) Serum adiponectin
6. Biochemical parameters
a) Serum lipid profile (Total cholesterol, HDL cholesterol, LDL cholesterol, Triglycerides)
|
Day 0 & Day 84 |
Change in the following parameters from Day 0 to Day 42 and 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 to Day 42 and Day 84 |
1. Safety (incidence of adverse events) assessment.
2. Abnormal findings in vital signs & medical interviews.
3. Abnormal changes in the hematology, urine & blood chemistry test results.
|
Day 0 & Day 84 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
07/02/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Although there are pharmacological agents available
to treat obesity / overweight, each drug has its unique profile of unfavorable
side effects. Despite the enormous advancements in medical research over the
past century, obesity / being overweight is still poorly managed. As obesity / overweight is a complex and interlinked clinical condition,
a therapy which addresses these abnormalities is always sought for. Hence the
quest for novel medications continues which can address obesity / overweight in
a holistic approach of disease management.
Terminalia bellirica is a versatile
medicinal plant with a rich history of use in traditional medicine and
promising pharmacological properties. Terminalia bellirica extract
contains multiple natural compounds 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, Terminalia bellirica
extract has demonstrated potential as a weight lowering agent in laboratory
animals. The present study is designed to evaluate the efficacy and safety of Terminalia bellirica 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 Terminalia
bellirica extract versus placebo for body fat loss in overweight subjects.” |