| CTRI Number |
CTRI/2025/08/092526 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Treatment of non alcoholic fatty liver disease in adults using Sesame extract(S3 complex) |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Three Arm, Placebo-Controlled Trial to Evaluate the
Antioxidant, Antiobesity and rejuvenation Potential of Sesame extract - S3 complex in Adults Suffering with NAFLD. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RRS/CL/NAFLD/2025 Version Number: 1.0 Date: 24th May 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd |
| Address |
Radiant Research Services Pvt Ltd
Peenya Industrial Area, Bengaluru-560 068 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 Pvt Ltd |
| Address |
Radiant Research Services Pvt Ltd
Peenya Industrial Area, Bengaluru-560 068 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 Pvt Ltd |
| Address |
Radiant Research Services Pvt Ltd
Peenya Industrial Area, Bengaluru-560 068 Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| M/s.Ingex Botanicals Pvt Ltd
No.508, Medini, 60 ft road, F Block,
Sahakaranagar, Bengaluru-560092,
Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
M/s.Ingex Botanicals Pvt Ltd |
| Address |
No.508, Medini, 60 ft road, F Block,
Sahakaranagar, Bengaluru-560092,
Karnataka, India. |
| Type of Sponsor |
Other [ [Nutraceutical supplement company]] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bio Actives Japan KK |
4-1-1, BAJ Bldg., Minami-Nagasaki, Toshima-Ku, Tokyo, JAPAN
171-0052 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K SUNIL NAIK |
Government Medical College & Govt. General Hospital (Old RIMSGGH) |
Department of General medicine ,Srikakulam-532001, Andhra Pradesh, India.
Ph: +91-8942-279033
Srikakulam
ANDHRA PRADESH |
9440828299
drsunilnaikggh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Government Medical College & Govt. General Hospital (Old RIMSGGH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K758||Other specified inflammatory liverdiseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Microcrystalline
cellulose |
Each capsule containing 700mg
Microcrystalline cellulose
to be taken once daily
immediately after
breakfast, Duration 90 days. |
| Intervention |
Sesame extract -
S3 complex |
Each capsule containing
Sesame extract - S3
complex 150 mg to be
taken once daily
immediately after
breakfast, Duration 90 days |
| Intervention |
Sesame extract -
S3 complex |
Each capsule containing
Sesame extract - S3
complex 75 mg to be
taken once daily
immediately after
breakfast, Duration 90 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged between 20 to 65 years of either sex with USG findings suggestive of NonAlcoholic Fatty Liver Disease grade I II and III.
2. BMI 25 to 35 kg per m2
3. Newly onset Diabetes mellitus (not more than 10 years)
4. Newly onset Hypertension (not more than 10 years)
5. Lipid profile
a. Lower HDL level
b. Higher LDL Triglyceride TC level
6. Liver function test AST or ALT (within more than 3 times of the upper limit of normal range)
7. Willing to participate in the study with a signed and dated written consent.
8. Able to comply with all required study procedures and schedule.
9. Able to comply and willing to follow the prescribed diet plan.
|
|
| ExclusionCriteria |
| Details |
1. Alcoholic and smoking.
2. Bariatric surgery within the last year.
3. Surgery within the last six months.
4. Severe cerebrovascular disease (cerebral infarction and cerebral hemorrhage) heart disease (angina pectoris myocardial infarction heart failure and arrhythmia requiring treatment) or malignant tumours within the last six months.
5. Taking drugs that affect body weight (fat absorption inhibitors appetite suppressants health food or supplements related to obesity psychiatric drugs betablockers diuretics contraceptives steroids and female hormones) within the last month.
6. Obese or overweight due to endocrine diseases (hypothyroidism Cushings syndrome).
7. Maintenance treatment acute and chronic for gastrointestinal disorders (gastric ulcer chronic digestive disorder irritable bowel syndrome).
8. Psychologically significant medical history or current disease (schizophrenia epilepsy anorexia bulimia) or a history of alcohol and other drug abuse.
9. Malabsorption syndrome autoimmune disease.
10. Participation in a commercial obesity program or obesity clinical trial within the last three or six months respectively.
11. Pregnancy lactation or planning to become pregnant during the study period.
12. Women not using a correct contraceptive method.
13. Allergic reaction to the study drug or herbal extractsdietary supplements.
14. Duration of jaundice greater than 3 months steatohepatitis advanced fibrosis cirrhosis viral hepatitis or other liver diseases.
15. Patients on immunomodulatory drugs coronary artery disease treatment or hepatoprotective drugs.
16. Treatment of NAFLD for at least three months prior to screening.
17. Receipt of any investigational drug or participation in another clinical trial within the preceding month.
18. Liver transplantation.
19. Use of Ayurvedic formulation or Complementary Alternative Medicine (CAM) therapy within the preceding two months.
20. Any condition that in the investigators opinion does not justify the patients inclusion for the study.
|
|
|
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:
1.Change in Percentage of patients who show improvement in liver Ultrasonography evaluation as compared to screening visit (Degree of
fatty infiltration, Hepatomegaly or hyper echoic shadow or resolution
of Ascites) from baseline to day 90
2.Change in Hepatic Steatosis index form baseline to day 90
3. Change in DEXA Scan form Day 0 to day 90
4.Change in Quality-of-Life Questionnaires (CLDQ) from baseline to Day 30, 60 and 90.
5.Change in BMI from baseline to Day 90.
6.Change in Body fat from baseline to Day 90. |
Screening visit, day 0, day 30,day 60, day 90. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes:
1.Change in Liver function parameters (AST, ALT, GGT and Total bilirubin, direct and indirect bilirubin, albumin and globulin) from
baseline to Day 30, 60 and 90
2.Change in Lipid profile (LDL, HDL, TC, TG) from baseline to Day 30, 60 and 90.
3.Change in Comparative evaluation of Anti-oxidant enzymes (Superoxide
dismutase, Catalase, Glutathione peroxidase) and MDA from baseline to Day 30, 60 and 90.
4.Change in TNF-alpha & IL-6 from baseline to Day 30, 60 and 90
5.Change in Leptin & Adiponectin form baseline to day 90
6.Change in Glycosylated Hemoglobin (HbA1C) form baseline to day 90. |
Screening visit, day 30,day 60, day 90. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
18/08/2025 |
| 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
|
Nonalcoholic fatty liver disease (NAFLD) is a chronic liver disease in which triglycerides accumulate within the hepatocytes of patients with minimal or no alcohol intake and without any other known cause. It comprises a wide spectrum of liver damage ranging from steatosis to nonalcoholic steatohepatitis (NASH), advanced fibrosis and cirrhosis [liu JP et al 2016]. For the sake of terminology, NAFLD is comprised of non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH). NAFL is characterized by steatosis of the liver, involving greater than 5% of parenchyma, with no evidence of hepatocyte injury. Whereas, NASH is defined by histologic terms, that is a necro inflammatory process whereby the liver cells become injured in a background of steatosis [Benedict M et al 2017]. Obesity has become a major health concern not only in high income countries, but also in low- and middle-income populations.
The pathogenesis of NAFLD involves oxidative stress, inflammation, and lipid metabolism dysregulation. Sesamolin, a major lignan present in sesame seeds, has been demonstrated to exhibit antioxidant, anti-inflammatory, and lipid-lowering properties, making it a potential therapeutic agent for NAFLD and obesity. |