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CTRI Number  CTRI/2026/01/102523 [Registered on: 30/01/2026] Trial Registered Prospectively
Last Modified On: 29/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Study to check the Safety and Efficacy of the Investigational Product (NS2128E03) in Improving Sexual Function in Men 
Scientific Title of Study   A Prospective, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Safety and Efficacy of the Investigational Product (NS2128E03) in Improving Sexual Function in Men 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
LCBS-NE-176, Version 1.0 dated 09 December 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harshith C S 
Designation  Assistant Professor 
Affiliation  BGS Global Institute of Medical Sciences 
Address  OPD No.3, Ground Floor, Department of General Medicine, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  8792516793  
Fax    
Email  drharshithcs.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jestin V Thomas 
Designation  Managing Director and CEO 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd. 
Address  Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jestin V Thomas 
Designation  Managing Director and CEO 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd. 
Address  Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar


KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Source of Monetary or Material Support  
Natural & Essential Oils Pvt. Ltd. No.74/2B, Manandavadi Road, HD Kote Road, Sriramapura, Mysuru- 570008, Karnataka 
 
Primary Sponsor  
Name  Natural & Essential Oils Pvt. Ltd. 
Address  No.74/2B, Manandavadi Road, HD Kote Road, Sriramapura, Mysuru- 570008, Karnataka 
Type of Sponsor  Other [Manufacturer of natural plant based Food ingredients and Nutraceutical ingredients] 
 
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 Harshith C S  BGS Global Institute of Medical Sciences  OPD No.03, Ground Floor,No. 67, BGS Health & Education City, Uttarahalli Road, Kengeri, Bengaluru, Karnataka 560060
Bangalore
KARNATAKA 		 8792516793

drharshithcs.research@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, BGS Global Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal hematological and biochemical parameters 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NS2128E03  Oral Administration of IP for 12 weeks, post dinner and 30 minutes before desired activity. 
Comparator Agent  Placebo  Oral Administration of IP for 12 weeks, post dinner and 30 minutes before desired activity. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  1.Healthy male adolescents and adults 2.Subjects who are married 3.Subjects with IIEF-15 score of 11-16 4.Subjects who have suffered from erectile dysfunction for a period of 3 or more months 5.Subjects who agreed to make at least four attempts a month at sexual intercourse with their spouse 6.Subjects with a BMI between 18.5 kg per m2 to 29.9 kg per m2 7.Subjects willing to refrain from taking any medications or supplements during the study 8.Subjects who agree to maintain their usual dietary habits and level of exercise 9. Subjects willing to refrain from taking any medications or preparations to improve sexual function during the study 10. Subjects willing to refrain from consuming alcohol 24 hours prior to the visit days 11.Subjects must be willing and able to provide informed consent and comply with the study procedures 
 
ExclusionCriteria 
Details  1.Subjects with ED caused by endocrine system diseases 2.ED patients suffering from hypogonadism, which can be treated by testosterone 3.Subjects who cannot have sexual intercourse 4.Subjects who use hormonal contraceptives or other hormonal therapies 5.Subjects unable to read and understand the informed consent and study materials 6. Subjects with a history of drug dependence, high alcohol intake,or the use of recreational drugs,or nicotine or caffeine dependence 7.Subjects with chronic medical conditions or medication use that may interfere with study outcomes 8.Subjects with psychiatric diagnoses including generalised anxiety or depression 9.Subjects taking multivitamins, herbal supplements, or other wellness products 10.Subjects suffering from a metabolic disorder and/or from severe chronic disease or from a disease found to be inconsistent with the conduct of the study by the investigator 11.Subjects with moderate to severe fatigue or having chronic fatigue syndrome 12.Subjects with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection 13.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, antihypertensive, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications 14.Subjects with uncontrolled hypertension at screening. 15. Subjects with uncontrolled hyperglycemia 16.Subjects who have been involved in a clinical study within the past 30 days 17.Subjects with hypersensitivity or a history of allergy to herbal products or any component of the study product 18.Any other condition(s) that, in the investigator’s opinion, would warrant exclusion or prevent the participant from completing the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change in testosterone level, sexual function, energy and fatigue compared with placebo.  Day 1, Day 14, Day 42, Day 84 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in hormonal biomarkers compared with placebo.  Day 1, Day 14, Day 42, Day 84 
Mean change in quality of life compared with placebo.   Day 1, Day 14, Day 42, Day 84 
To assess the safety of the IP compared with placebo  Day 1, Day 14, Day 42, Day 84 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   12/02/2026 
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)  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  
This is a randomized, double-blind, placebo-controlled, parallel group clinical interventional study. The subjects will be explained about the study procedures, the risks and discomforts, the investigational product. Informed consent will be obtained from subjects who are willing to participate in the study. The subjects who fulfil the study inclusion criteria and who do not meet any exclusion criteria will be eligible for the study. The subjects will be randomized into one of the treatment arms as per randomization schedule. The subject will be instructed to consume the IP for 12 weeks. The subjects will be required to come for the follow-up assessments on Day 14, Day 42 and Day 84. 
 
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