| CTRI Number |
CTRI/2025/10/095845 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
05/06/2026 |
| 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 obesity subjects |
|
Scientific Title of Study
|
A 12-Week, Randomized, Double Blind, Placebo Controlled, Parallel Study to Evaluate the Efficacy and Safety of Caralluma fimbriata On the Improvement of Weight Management. |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| RRS/CL/WMS/2025 Version: 2.0 Date: 01 May 2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Private Limited |
| Address |
Radiant Research Services Private Limited
# 99/A, 8 Main, III Phase, Peenya Industrial Area, Bengaluru - 560058,Karnataka, India
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Private Limited |
| Address |
Radiant Research Services Private Limited
# 99/A, 8 Main, III Phase, Peenya Industrial Area, Bengaluru - 560058,Karnataka, India
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Private Limited |
| Address |
Radiant Research Services Private Limited
# 99/A, 8 Main, III Phase, Peenya Industrial Area, Bengaluru - 560058,Karnataka, India
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| 3 H Labs Co., LTD
# 1203~1204, 77, Changnyong-daero 256 beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea (16229) |
|
Primary Sponsor
Modification(s)
|
| Name |
Three H Labs Co LTD |
| Address |
1203-1204, 77, Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea
Zip code: 16229 |
| Type of Sponsor |
Other [Nutraceutical supplement company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manoj C |
Dr. B. R. Ambedkar Medical College and Hospital |
2nd floor, room no 2, General Medicine Kadugondanahalli, Bengaluru, Karnataka 560045
Bangalore
KARNATAKA |
9740937958
cm9740937958@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr. B. R. Ambedkar Medical College Ethics Committee |
Approved |
| Dr. B. R. Ambedkar Medical College Ethics Committee |
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 |
| Intervention |
Caralluma fimbriata |
Dose :450mg,Doasge form:Capusle,
Duration 84days, 1 capsule per day, after meal |
| Comparator Agent |
Placebo |
Dose :450mg,Doasge form:Capusle, Duration 84days, 1 capsule per day, after meal |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Male and female individuals aged from 19 to 60 both inclusive
2 BMI between greater than or equal to 25 and less than 32 kg per m2
3 Those who voluntarily agrees to participate and signs on informed consent form
|
|
| ExclusionCriteria |
| Details |
1 Participants with a history of hypersensitivity to drugs food ingredients herbal extracts or dietary supplements
2 Participants who have had participated in a commercial weight loss program or clinical trial for obesity within the last three months
3 Participants taking drugs or diet foods that affect their weight within 3 months prior to screening absorption inhibitors appetite suppressants health functional foodssupplements related to obesity improvement psychiatric drugs such as depression diuretics contraceptives steroids female hormones
4 Participants with intentional weight loss of at least 5 percentage within 3 months prior to screening
5 Participants who have undergone surgery such as gastroplasty and intestinal resection to lose weight within 6 months prior to screening
6 Endocrine diseases such as hypothyroidism and Cushings syndrome
7 Participants with severe cerebrovascular disease cerebral infarction cerebral hemorrhage etc heart disease angina pectoris myocardial infarction heart failure arrhythmia in need of treatment lung disease chronic obstructive pulmonary disease etc within the last 6 months However those who are clinically stable may participate in the trial at the investigator discretion
8 Serious dysfunction of the liver alanine and aspartate aminotransferase levels of 3.0 times the upper limit or normal or kidney creatinine more than 2.0 mg per dL
9 Uncontrolled hypertension blood pressure More or equal than 160 per 100 mmHg
10 Fasting blood glucose more or equal than 126 mg per dL or random blood glucose more or equal than 200 mg per dL or diabetic patients taking oral hypoglycaemic agents or insulin
11 Malignant tumor diagnosed within 3 years prior to screening
12 Participants who complain of severe gastrointestinal symptoms such as heartburn and indigestion
13 Participants with a psychologically significant medical history or current disease schizophrenia epilepsy anorexia bulimia etc or a history of alcohol or the other drug abuse
14 Participants who have irregular dietary habit and intakes excessive alcohol caffeine and smoke
15 Participants who are determined to be unable to exercise due to musculoskeletal disorders
16 Pregnant or lactating participants or women of childbearing age who do not agree to use contraception during the trial
17 Participants with a history of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing
18 Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigators opinion.
|
|
|
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 outcome:
•DEXA (Dual Energy X-ray Absorptiometry)
Body Fat Mass
Body Fat Rate.
|
Day 1 and Day 84 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Secondary Outcomes:
•Body Weight
•Body Mass Index
• Safety Assessment ( Screening Visit, Day 84)
•Waist circumference,
•Hip circumference
•Waist-hip ratio
•Skinfold of Biceps & Triceps of Arm (Day 1 & Day 84) |
screening visit, Day 1, Day 42 & Day 84 |
Secondary outcomes:
•DEXA
• Lean Mass
• Body Fat Mass of Individual Parts (Arm, Legs, Trunk, Android, Gynoid)
• Muscle Mass
• Appendicular Skeletal Muscle Mass
• CT
1.Visceral fat volume
2.Subcutaneous fat volume
3.Total abdominal fat volume
4.Visceral/subcutaneous fat volume ratio
•Blood Lipid parameters
Total cholesterol
HDL-cholesterol
LDL-cholesterol
Triglyceride
•Leptin
•Adiponectin
•GLP-1
•Ghrelin
•PYY (Peptide YY)
•Fasting blood glucose
•Fasting insulin
•HOMA-IR |
Day 1 & 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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
22/12/2025 |
| 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)
|
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 chronic and progressive disease with serious health consequences, but weight loss brings significant improvements in metabolic markers and overall health. Even small amounts of weight loss yield improvements in metabolic markers, with greater benefits observed as weight loss increases. Overweight and obesity, and a static body mass index (BMI) commonly conceal sarcopenia (gain in body fat but loss of muscle mass and functional capacity) in older people, aggravated by inactivity. The prevalence of obesity (defined as BMI 30 kg/m2) in the over 80-year group is about a half of that in the 50–59-year group Caralluma fimbriata, a species of the genus Caralluma R. Brown (family Apocynaceae, subfamily Asclepiadoideae), is a perennial, quadrangular succulent native to the arid regions of tropical Asia, the southern Mediterranean, and parts of Africa. C. fimbriata is particularly rich in bioactive compounds such as pregnane glycosides, saponins, flavonoids, alkaloids, and terpenoids, many of which contribute to its pharmacological activities. It has demonstrated promising anti-diabetic, anti-obesogenic, antioxidant, hepatoprotective, and anti-inflammatory properties.
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