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CTRI Number  CTRI/2025/11/098038 [Registered on: 25/11/2025] Trial Registered Prospectively
Last Modified On: 23/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Clinical Study on Salacilean for reducing body fat 
Scientific Title of Study   A 12-week randomized, double-blind, placebo-controlled clinical study for the evaluation of the body fat reduction efficacy and safety Salacilean from Salacia reticulata extract. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
RRS/CL/ADL/SR/2024/001 Version : 1.0 Date: 21st June 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lokesh S  
Designation  Principal Investigator  
Affiliation  The Oxford Medical College, Hospital and Research Centre 
Address  Hosur Road Yadavanahalli, Attibele hobli,Anekal Taluk Bengaluru 562107 Department of General Medicine Ground floor Professor room no 1

Bangalore
KARNATAKA
562107
India 
Phone  9972988222  
Fax    
Email  lokeshsdoc@gmail.com   
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr. Sravani T 
Designation  Manager Technical 
Affiliation  Botanic Healthcare Pvt. Ltd 
Address  TSIIC Industrial Development Area, Plot - 16-1-12 and 13 Nacharam (V), Uppal (M), Hyderabad, Telangana INDIA

Hyderabad
TELANGANA
560058
India 
Phone  7995688815  
Fax    
Email  research1@botanichealthcare.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr. Sravani T 
Designation  Manager Technical 
Affiliation  Botanic Healthcare Pvt. Ltd 
Address  TSIIC Industrial Development Area, Plot – 16-1-12 and 13 Nacharam (V), Uppal (M), Hyderabad, Telangana INDIA

Hyderabad
TELANGANA
500076
India 
Phone  7995688815  
Fax    
Email  research1@botanichealthcare.com  
 
Source of Monetary or Material Support  
ADL Holdings 604, 17 Teheran-ro 87-gil, Gangnam-gu, Seoul, Republic of Korea (06169)  
 
Primary Sponsor  
Name  ADL Holdings  
Address  604, 17 Teheran-ro 87-gil, Gangnam-gu,Seoul, Republic of Korea (06169) 
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 Lokesh S   The Oxford Medical College, Hospital and Research Centre  Hosur Road Yadavanahalli, Attibele hobli,Anekal Taluk Bengaluru-562107 Department of General Medicine Ground floor Professor room no 1
Bangalore
KARNATAKA 		 9972988222

lokeshsdoc@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee The Oxford Medical College, Hospital & Research Centre   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 :450mg,Doasge form:Capusle, Duration 84days, 1 capsule per day, after breakfast 
Intervention  Salacilean  Dose :450mg,Doasge form:Capusle, Duration 84days, 1 capsule per day, after breakfast  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adults aged between 19 and 65 who are healthy and capable of normal physical activity.
2. Adults who belong to the range of BMI 25 – 34.9 kg per m2 and do not take drugs.
3. Adults who voluntarily decide to participate and agree in writing to abide by the precautions after hearing a detailed explanation of the clinical study and fully understand it.  
 
ExclusionCriteria 
Details  A. Clinical Study
1. Adults who did not sign the research subject consent form
2. Adults who participated in other clinical studies within 2 months before the screening test
B. Weight
3. Subjects whose body weight has changed by 5-10 percent and whose weight gain or loss is 5kg or more within 3 months.
C. Disease Status
4. Subjects who have undergone obesity surgery within the last year
5. Subjects who have undergone surgery within the last 6 months
6. Subjects who are receiving or received psychotropic drug treatment and psychological treatment due to mental disorders (depression,
schizophrenia)
7. Patients with cardiovascular disease, arrhythmia, heart failure, myocardial infarction, cerebrovascular disease, and those with a history
of using a cardiac pacemaker
8. Patients with diabetes who are under medication or cannot be controlled
9.Gastrointestinal disease (Crohn’s disease)/gastric resection/irritable bowel syndrome
10. Chronic inflammation (kidney, liver, pancreas) and infectious diseases, hypertension (systolic/diastolic 160/100mmHg or more)
11. Patients with a history of heart disease or cancer
12. Patients with thyroid disease or those taking thyroid drug substitutes
13. Patients with malabsorption syndrome/ autoimmune disease
14. Patients with liver and kidney failure
15. Subjects taking dietary supplements or drugs that may affect blood sugar and lipid metabolism, body composition, and eicosanoid production
(e.g., salicylates, dairy products)
16. Patients with anaemia/ porphyria)
17. Subjects suffering from pancreatic disease, those with a history of eating disorders.
D. Physiological status
18. Women who are pregnant or lactating
19. Women within 6 months of giving birth
E. Medication and health functional food products
20. Subjects taking anti-obesity drugs
21. Drug addicted subjects
22. Subjects who are taking blood sugar lowering drugs, insulin, or diabetes medications
23. Subjects who are taking drugs that affect energy metabolism, blood sugar, appetite, and gastrointestinal activity
24. Subjects taking medications that affect carbohydrate and lipid metabolism, weight and hormones.
25. Subjects taking immunosuppressants, proton pump inhibitors (PPI), H2 blockers, and non steroidal anti-inflammatory drugs
26. Subjects who are taking health functional food products for reducing body fat
F. Life Habit
27. Women who do not use the correct method of contraception
28. Subjects who have been on weight management for the past few years
29. Subjects who have participated in a weight loss program within the last 3 months
30. Subjects who consume excessive alcohol (exceeding 2g per day MFDS Guidelines) Ingested alcohol content (g): Intake (ml) x alcohol content
(%) x 0.8 (alcohol specific gravity)/ 100.
31. Excessive smokers (more than 25 cigarettes per day)
G. Allergy
32 Subjects with allergies/ side effects to the test substance excluded from the study
H. Others
33. Subjects with serum creatinine 1.5mg/dL or higher
34. Subject whose AST (aspartate aminotransferase) and ALT (alanine aminotransferase) level is three times or more than the maximum normal level
35. Subject who is judged unsuitable for the human application test by the researcher
36. Hepatitis B or C carriers. Subjects who are judged unfit to participate in the research by the research director due to other reasons.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcomes
1. DEXA – Change in body fat mass (kg), body fat percentage (%BF) 		 Day 1 and Day 84 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes
1. Body Weight
2.Waist circumference, Hip circumference, WHR (waist/hip ratio)
3. BMI
4. Basal metabolic rate
5. Safety Assessment (Screening Visit, Day 84) 		 Day 1, Day 42, Day 84 
Secondary Outcome
1. Lean mass by DEXA
2. Abdominal visceral fat & subcutaneous fat area- by CT
3. Blood Lipid
4. Secreted Hormones: Adiponectin, Leptin & Insulin 		 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   N/A 
Date of First Enrollment (India)   06/12/2025 
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.  
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