Role of Ashwagandha Extract (Capsule KSM-66 300 mg) in Improving Sexual Health in Healthy Men

Sexual Health Clinical Trial

Official title: Role of Ashwagandha Extract (Capsule KSM-66 300 mg) in Improving Sexual Health in Healthy Men: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

Status Recruiting

Clinical Trial Summary

The clinical study aims to evaluate Efficacy and Safety of KSM66 Ashwagandha Standardized Root Extract for Improving Sexual Health in Healthy Men by measuring sex hormone levels in participant's blood, analyzing results of questionnaires, and monitoring adverse events in the post-marketing phase. Changes in the sex hormone levels in blood may affect sexual health or sexual health satisfaction. Efficacy is defined as increase in sex hormone levels in blood, and improvement in results or scores of assessment questionnaires.

Clinical Trial Description

To qualify for this study, participant must be a healthy male between 30 to 50 years of age with unsatisfactory sexual health. Participants must NOT be taking medications or receiving treatments for erectile dysfunction. Participants are sexually active, and currently in a stable heterosexual relationship. Participants must agree to continue their routine diet and physical activities for the entire study. Participants should avoid using any NEW dietary supplements, multivitamins, or oral nutrition supplements throughout the study.

In this study, a maximum of 45 patients will be enrolled. The goal is to complete the study with at least 40 patients. At the initial visit, prospective patients will be screened for enrollment based on the requirements of the study, medical history, and clinical examination. Before starting any study related procedures, participants will be explained about the study in detail and a written informed consent will be obtained from participants prior to participation in this study. This document is a part of the written informed consent procedure. A detailed medical history including the associated conditions will be recorded. A general and physical examination will be performed to detect any abnormal parameters. If participants meet the eligibility criteria, they will be enrolled in the study.

After enrollment in the study, participants will be randomly assigned to take one capsule of KSM 66 Ashwagandha (300 mg) or one capsule of placebo two times daily after breakfast and every night at bedtime with food, preferably 30 minutes before the anticipated sexual intercourse with a glass of water for 8 weeks. There is a 50% chance that instead of 'Ashwagandha capsule' participants will receive 'Placebo capsule'. This placebo capsule will be identical in size, shape, and color to the 'Ashwagandha capsule'. The placebo capsule is harmless. It has the ingredient of starch powder made from corn, wheat, or potato. Participants will have to record the use of their assigned product on a daily diary for 8 weeks.

Participants will be monitored throughout the study. The study consists of two 60-minute onsite visits for visit 1 and visit 3, and one 40-minute remote visit via the phone for visit

2. After the initial visit 1 at the clinic (screening, baseline/randomization) (Day 1), participants will be monitored and assessed remotely at visit 2 (week 4) over the phone. Then, participants will have to come back to the clinic for assessments at visit 3 (week 8). During visit 1 and visit 3, blood will be collected from participants, physical examinations, and general examinations will be performed. During physical examinations, a medically trained personnel will measure participants' vital signs including systolic blood pressure, diastolic blood pressure, pulse rate, body temperature, respiratory rate, and body mass index. During general examination, a systemic review of different body systems will be performed to see if there are any significant abnormalities or findings.

For blood sample collection, participants' right or left arm will be used as the blood draw site. Investigators will take 12.5 ml of blood (less than the size of a tablespoon) from each participant to measure different sex hormone levels in his or her blood, such as dihydrotestosterone, follicle-stimulating hormone, luteinizing hormone, prolactin, and testosterone. Participants' blood samples will only be used for research and result analysis in this study. No more than 12.5 ml of blood will be drawn from each participant with a needle and syringe. All needles and syringes are brand new, and not recycled. All blood draws will be performed by professionally trained phlebotomists.

During remote visit 2 via phone, Satisfying Sexual Events (SSEs), Sexual Desire Inventory (SDI-2), International Index of Erectile Function (IIEF), Quality of Life (QoL) assessment questionnaires will be conducted over the phone. Side effects will be monitored, concomitant medications and study drug compliance will also be checked over the phone in visit 2.

At each visit, Satisfying Sexual Events (SSEs), Sexual Desire Inventory (SDI-2), International Index of Erectile Function (IIEF), Quality of Life (QoL) assessments will be conducted. Side effects will be monitored during each visit of the study period. Participants' results on all assessment questionnaires are confidential, and will only be reviewed by study staff, ethical review board members, and the FDA (if necessary). At visit 3 (week 8), participants are required to return any remaining testing products to the San Francisco Research Institute (at 2345 Ocean Ave, San Francisco, CA 94127) in person. Duration of the study is 8 weeks. ;

Related Conditions & MeSH terms

• Sexual Health

• NCT number: NCT05840731
• Study type: Interventional
• Source: SF Research Institute, Inc.
• Contact: John Ademola
• Phone: 415-845-4638
• Email: jademola@sfinstitute.com
• Status: Recruiting
• Phase: Phase 4
• Start date: August 7, 2023
• Completion date: October 12, 2023