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CTRI Number  CTRI/2022/10/046429 [Registered on: 13/10/2022] Trial Registered Prospectively
Last Modified On: 31/08/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Health functional food]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of herbal extract on reducing body fat in healthy adults  
Scientific Title of Study   A randomized, double blind, placebo controlled, parallel study to evaluate the efficacy and safety of YC-1102 on reducing of the body fat  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Meghana Murthy  
Designation  MBBS, MD (Internal Medicine)  
Affiliation  Vagus Super Speciality Hospital 
Address  No. #6,7,8,18th, 4th Main, Malleshwaram West, Bengaluru

Bangalore
KARNATAKA
560 055
India 
Phone  7259214727  
Fax    
Email  meggydoc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jang Yul Kwak  
Designation  Director 
Affiliation  Syncorp Health Pvt Ltd 
Address  Building 06, 3rd Floor, 2nd Main Rd, Opposite To British Biologicals Sarvobhogam Nagar, Arekere Bangalore KARNATAKA

Bangalore
KARNATAKA
560076
India 
Phone  8970888899  
Fax    
Email  deankwak@syncorp.in  
 
Details of Contact Person
Public Query  
Name  Subham Dutta 
Designation  Director  
Affiliation  Syncorp Health Pvt Ltd 
Address  Building 06, 3rd Floor, 2nd Main Rd, Opposite To British Biologicals Sarvobhogam Nagar, Arekere Bangalore KARNATAKA

Bangalore
KARNATAKA
560076
India 
Phone  08049774772  
Fax    
Email  subham.dutta@syncorphealth.com  
 
Source of Monetary or Material Support  
Research Mentor Co. ltd 120 Heungdeok Jungang-ro, Giheung-gu, Yongin-si, Gyeonggi-do, 21F 2105-1  
 
Primary Sponsor  
Name  Sangol Farm 
Address  987 Seowon-ro Seowon-myeon, Hoengseong-gun, Gangwon-do South Korea  
Type of Sponsor  Other [Health functional Foods] 
 
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 Srihari US  Sanjeevini Hospital  No 761, 7th Main Road, Last Bus Stop, Swimming Pool, Mahalakshmi Layout, Bengaluru, Karnataka, India- 560086 Bangalore KARNATAKA
Bangalore
KARNATAKA 		 9480025659

us.srihari@gmail.com 
Dr Meghana Murthy  Vagus Super Speciality Hospital  18th Cross, Margosa Road, Malleshwaram west, Bengaluru, Karnataka, India- 560055 Bangalore KARNATAKA
Bangalore
KARNATAKA 		 7259214727

meggydoc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Sanjeevini Hospital Institutional Ethics Committee  Approved 
Sanjeevini Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  BMI between ≥ 25 - less than 30 kg/m2  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Oral Tablets; Twice daily at morning and night for 12 weeks. [i.e., 2x (2 tablets) for 12 weeks] 
Intervention  YC-1102  960 & 720 mg /Day Oral tablets; Twice daily at morning and night for 12 weeks. [ie., 2x (2 tablets) for 12 weeks] 
 
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) years
2. BMI between ≥ 25, <30 kg/m2
3. Participants 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 foods/supplements related to obesity improvement, psychiatric drugs such as depression, diuretics, contraceptives, steroids, female hormones)
4. Participants with intentional weight loss of at least 5% 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 Cushing’s 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 > 2.0 mg/dL)
9. Uncontrolled hypertension (blood pressure ≥ 160/100 mmHg)
10. Fasting blood glucose ≥ 126 mg/dL or random blood glucose ≥ 200 mg/dL, or diabetic patients taking oral hypoglycemic 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 are determined to be unable to exercise due to musculoskeletal disorders
15. Pregnant or lactating participants, or women of childbearing age who do not agree to use contraception during the trial
16. 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.
17. Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigator’s opinion  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Change in body fat rate %   Baseline and week 12 
 
Secondary Outcome  
Outcome  TimePoints 
1) Change in physical measurement
✓ Weight
✓ Waist circumference
✓ hip circumference
✓ waist circumference/hip circumference ratio  		 Baseline, week 4, week 8, week 12  
2) Change in Body Mass Index (BMI)   Baseline, week 4, week 8, week 12 
3) Blood lipid concentration (Total-C, HDL-C, LDL-C, Triglyceride)   Baseline, week 4, week 8, week 12 
4) DEXA (Dual-Energy X-ray Absorptiometry)
✓ Body fat amount(g)
✓ Lean body mass(g)  		 Baseline, week 12  
5) Abdominal fat CT (computed tomography) (between lumbar spine 4-5)
✓ visceral fat area,
✓ subcutaneous fat area,
✓ total abdominal fat area,
✓ visceral fat/subcutaneous fat area ratio (VSR) Measured.  		 Baseline, week 12  
6) Serum concentration measurements
✓ leptin
✓ adiponectin 		 Baseline, week 12 
Other Evaluations
a) Dietary Record
b) Physical activity (GPAQ)
c) Lifestyle survey (GATS;AUDIT-C;CCQ)  		 Baseline & Week 12 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   14/10/2022 
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    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Fat accumulation is linked to muscle weakening and poor function and demonstrate worse  physical performance.  Maintaining a healthy body fat percentage can help reduce risk of various diseases and improve overall health. The rationale  of  this  study is to evaluate the  clinical  efficacy  and safety  of  YC-1102  tablet  on  reducing  the body  fat. 
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