RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-08-07

Study Completion:2023-10-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05840731

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 50 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Male participants between 30 to 50 years of age having poor sexual satisfaction based on his own perception since at least past 3 months. * Participants whose IIEF-EF domain score is between 11 to 16 (i.e., moderately impaired). * Participants in a stable, monogamous behavior and heterosexual relationship. * Participants who are willing to stay away from any other medicines or treatments for Erectile Dysfunction (ED) during this study period. * Participants who are willing to have 4 or more attempts of sexual intercourse each month. * The participate should inform their partner about the study * His partner should be willing to let him participate in the study * Participants who are willing to take proper contraceptives during the study and within 3 months after the study completed. Proper contraceptives for participants include the following: (a) vasectomy (b) male condom with or without spermicide. Proper contraceptives for participant's partner include the following: (a) combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation and/or implantation, such as oral birth control pills, intravaginal rings, or transdermal patches. (b) progesterone only hormonal contraception associated with inhibition of ovulation, such as oral pills, or injectable. (c) implantable progesterone only hormonal contraception associated with inhibition of ovulation and/or implantation, such as intrauterine device, intrauterine hormone releasing system. (d) bilateral tubal occlusion. (e) female condom with or without spermicide. (f) diaphragm with spermicide. (g) cervical cap with spermicide. (h) vaginal sponge with spermicide. (i) progesterone only oral hormonal contraception. * Participants who have voluntarily decided to participate in this study and signed the informed consent form. * Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff. * Participants who are reliable, honest, compliant, and agree to co- operate with all trial evaluations as well as to be able to perform them as per investigator's opinion. * Participants willing to follow the protocol requirements and agree to take an investigational product till 8 weeks ± 3 days.	* Participants on any medication or supplement (e.g., ginseng, Sildenafil, vardenafil, tadalafil, avanafil) for improving the sexual function during the 3 months prior to study commencement. * Participants having any clinically significant medical history, medical finding or an on-going medical or psychiatric condition or any acute illness which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol. * Individuals participating in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements (for improving the sexual function during the 3 months prior to study commencement). * Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to usual doses). * Participants with anatomical malformations of the penis. * Participants with primary hypoactive sexual desire. * Participants with ED, which is caused by any other primary sexual disorder, like hypopituitarism, hypothyroidism, or hypogonadism, hypergonadotropic. * Participants who have a spinal injury or have had a radical prostatectomy. * Participants with ED, which is caused by the failure of surgery in the pelvic cavity. * Participants with penis deformity or penile implants. * Participants with a history of malignancy. * Participants with a major refractory psychiatric disorder or significant neurological abnormalities. * Participants with alcohol addiction or persistent abuse of drugs of dependence. * Partner of the participant is not planning to have pregnancy for next six months. * Participants who are participating or discontinued participation in the past 3 months from any other clinical trial or are planning to father a baby or are in a relationship with a pregnant partner.

Inclusion Criteria

Exclusion Criteria

* Male participants between 30 to 50 years of age having poor sexual satisfaction based on his own perception since at least past 3 months.
* Participants whose IIEF-EF domain score is between 11 to 16 (i.e., moderately impaired).
* Participants in a stable, monogamous behavior and heterosexual relationship.
* Participants who are willing to stay away from any other medicines or treatments for Erectile Dysfunction (ED) during this study period.
* Participants who are willing to have 4 or more attempts of sexual intercourse each month.
* The participate should inform their partner about the study
* His partner should be willing to let him participate in the study
* Participants who are willing to take proper contraceptives during the study and within 3 months after the study completed. Proper contraceptives for participants include the following: (a) vasectomy (b) male condom with or without spermicide. Proper contraceptives for participant's partner include the following: (a) combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation and/or implantation, such as oral birth control pills, intravaginal rings, or transdermal patches. (b) progesterone only hormonal contraception associated with inhibition of ovulation, such as oral pills, or injectable. (c) implantable progesterone only hormonal contraception associated with inhibition of ovulation and/or implantation, such as intrauterine device, intrauterine hormone releasing system. (d) bilateral tubal occlusion. (e) female condom with or without spermicide. (f) diaphragm with spermicide. (g) cervical cap with spermicide. (h) vaginal sponge with spermicide. (i) progesterone only oral hormonal contraception.
* Participants who have voluntarily decided to participate in this study and signed the informed consent form.
* Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff.
* Participants who are reliable, honest, compliant, and agree to co- operate with all trial evaluations as well as to be able to perform them as per investigator's opinion.
* Participants willing to follow the protocol requirements and agree to take an investigational product till 8 weeks ± 3 days.

* Participants on any medication or supplement (e.g., ginseng, Sildenafil, vardenafil, tadalafil, avanafil) for improving the sexual function during the 3 months prior to study commencement.
* Participants having any clinically significant medical history, medical finding or an on-going medical or psychiatric condition or any acute illness which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
* Individuals participating in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements (for improving the sexual function during the 3 months prior to study commencement).
* Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to usual doses).
* Participants with anatomical malformations of the penis.
* Participants with primary hypoactive sexual desire.
* Participants with ED, which is caused by any other primary sexual disorder, like hypopituitarism, hypothyroidism, or hypogonadism, hypergonadotropic.
* Participants who have a spinal injury or have had a radical prostatectomy.
* Participants with ED, which is caused by the failure of surgery in the pelvic cavity.
* Participants with penis deformity or penile implants.
* Participants with a history of malignancy.
* Participants with a major refractory psychiatric disorder or significant neurological abnormalities.
* Participants with alcohol addiction or persistent abuse of drugs of dependence.
* Partner of the participant is not planning to have pregnancy for next six months.
* Participants who are participating or discontinued participation in the past 3 months from any other clinical trial or are planning to father a baby or are in a relationship with a pregnant partner.

Contacts and Locations

Study Contact

John Ademola

CONTACT

415-845-4638

jademola@sfinstitute.com

Study Locations (Sites)

San Francisco Research Institute

San Francisco, California, 94127

United States

Collaborators and Investigators

Sponsor: SF Research Institute, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-07

Study Completion Date2023-10-12

Study Record Updates

Study Start Date2023-08-07

Study Completion Date2023-10-12

Terms related to this study

Additional Relevant MeSH Terms

Sexual Health