CTRI/2026/01/102523Not yet recruitingNot Applicable
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
Natural & Essential Oils Pvt. Ltd.1 site in 1 country50 target enrollmentStarted: February 12, 2026Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 70.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •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
- •Subjects willing to refrain from taking any medications or preparations to improve sexual function during the study
- •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.
Exclusion Criteria
- •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
- •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.
- •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.
Investigators
Dr Harshith C S
BGS Global Institute of Medical Sciences
Study Sites (1)
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