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CTRI Number  CTRI/2025/01/079658 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 27/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To determine the safety and efficacy of Lycopene powder in healthy adult subjects  
Scientific Title of Study   A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Lycopene 20% powder (a standardized Solanum lycopersicum extract) in Healthy Adult Subjects. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
VH/RD/CH/01, Version 1.1 dated 14 NOV 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K Sunil Naik 
Designation  Professor, HOD-Medicine 
Affiliation  Government Medical College & Government General Hospital (Old RIMSGGH) 
Address  OPD No 13, 1st Floor, Department of Medicine, Government Medical College & Government General Hospital (Old RIMSGGH)

Srikakulam
ANDHRA PRADESH
532001
India 
Phone  9440828299  
Fax    
Email  rimsresearch@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sudeep 
Designation  Research Scientist  
Affiliation  Vidya Herbs Pvt Ltd 
Address  R&D Centre for Excellence No.14A, KIADB Industrial Area, Jigani 1st Phase, Bangalore

Bangalore
KARNATAKA
560105
India 
Phone  09620384780  
Fax    
Email  research@vidyaherbs.com  
 
Details of Contact Person
Public Query  
Name  Dr Sudeep 
Designation  Research Scientist  
Affiliation  Vidya Herbs Pvt Ltd 
Address  R&D Centre for Excellence No.14A, KIADB Industrial Area, Jigani 1st Phase, Bangalore

Bangalore
KARNATAKA
560105
India 
Phone  09620384780  
Fax    
Email  research@vidyaherbs.com  
 
Source of Monetary or Material Support  
Vidya Herbs Private Limited Vidya Building, N3-3 24th Main JP Nagar, 1st Phase, Bangalore - 560 078, Karnataka, India 
 
Primary Sponsor  
Name  Vidya Herbs Pvt Ltd 
Address  Vidya Building, N3-3 24th Main JP Nagar, 1st Phase, Bangalore - 560 078 Karnataka, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Sunil Naik  Government Medical College & Government General Hospital (Old RIMSGGH)  OPD No 13, 1st Floor, Government Medical College & Government General Hospital (Old RIMSGGH)
Srikakulam
ANDHRA PRADESH 		 9440828299

rimsresearch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Medical College and Government General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  hyperlipidemia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lycopene 20% powder   250 mg capsule containing 125 mg of Lycopene 20% powder 
Comparator Agent  Placebo  placebo capsule-250 mg 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Male and female subjects aged 40-70 years.
2) Participants at risk for cardiovascular disease, as indicated by one or more of the following:
• Elevated LDL cholesterol levels (≥ 120 mg/dL to ≤160 mg/dL).
3) Participants must be on a stable medication regimen for at least 3 months prior to the study, if applicable.
4) Participants with BMI 18.5-24.9kg/m2.
5) Individuals must be able and willing to provide informed consent.
6) Individuals must be able to comply with the study protocol and procedures.
 
 
ExclusionCriteria 
Details  1) Subjects with a history of hypersensitivity to lycopene.
2) Subjects with a BMI ≥25 kg/m2
3) Subjects with a family history of hypercholesterolemia
4) Current use of any supplement, herbal products or drugs for the management of hyperlipidaemia.
5) Presence of significant liver or renal disease.
6) History of major cardiovascular events (e.g., myocardial infarction, stroke) within the last 6 months.
7) Active malignancy or history of cancer within the last 5 years.
8) Pregnant or lactating women, and women of childbearing potential not using adequate contraceptive measures or found positive for a urine pregnancy test.
9) Participation in another clinical trial within 30 days prior to study entry.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change in serum levels of LDL.  Baseline, Day 42, Day 84 
 
Secondary Outcome  
Outcome  TimePoints 
1) Change in serum levels of total cholesterol, HDL cholesterol and triglycerides   Baseline, Day 42, Day 84 
2) Change in the vital signs .  Baseline, Day 42, Day 84 
3) Change in the safety parameters including Complete Blood Count (CBC), blood Chemistry, thyroid profile, liver function tests (ALT, AST, and bilirubin) and renal function tests (creatinine and BUN)  Baseline, Day 84 
4) Assessment of tolerability, incidence and severity of adverse events.  Day 42 and Day 84 
 
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 
Date of First Enrollment (India)   11/02/2025 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
The purpose of this study is to evaluate the beneficial effects of Lycopene powder (a standardized Solanum lycopersicum extract) on safety and efficacy in healthy adult subjects.
 
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