None listed
Conditions
Interventions
Intervention1: NS2128E03: Oral Administration of IP for 12 weeks, post dinner and 30 minutes before desired activity.
Control Intervention1: Placebo: Oral Administration of IP for 12 weeks, post dinne
Sponsors
Natural & Essential Oils Pvt. Ltd.
Eligibility
Inclusion criteria
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 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
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in testosterone level, sexual function, energy and fatigue compared with placebo.Timepoint: Day 1, Day 14, Day 42, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in hormonal biomarkers compared with placebo.Timepoint: Day 1, Day 14, Day 42, Day 84;Mean change in quality of life compared with placebo.Timepoint: Day 1, Day 14, Day 42, Day 84;To assess the safety of the IP compared with placeboTimepoint: Day 1, Day 14, Day 42, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd.
Outcome results
None listed