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

NCT05840731 | Unknown Phase 4

• 1 other identifier: Ixoreal-MSD-CT-01-22
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sexual Health

Outcome Measures

Primary Outcomes (1)

• Number of Satisfying Sexual Events (SSEs)

  All enrolled subjects will be asked about SSEs 4 weeks prior Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) and then throughout the study. It will include subject's inputs for number of intercourse and non-intercourse sexual events, number of orgasms, level of sexual desire, and satisfying sexual activity experienced. The subjects will be asked to mark a score for their sexual desire. They will be asked, "Indicate your most intense level of sexual desire in the last 24 hours/since your last visit." Potential responses included "no," "low," "moderate," or "strong", scored 0-3 (0 indicating no desire and 3 indicating the highest level of desire): 0 = No desire 1. = Low desire 2. = Moderate desire 3. = Strong desire Number of SSEs at Visit 3-End of study visit, (Week 8), will be compared with that of Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), and Visit 2 (Week 4).

  8 weeks

Study Arms (2)

Ashwagandha

EXPERIMENTAL

KSM-66 Ashwagandha is the active ingredient in Waithania somifera, a medicinal plant in Indian medicine. Ashwagandha is known as an adaptogen, an herb in capsule form that protects the body from stress. After enrollment in the study, 50% of participants will be randomly assigned to take one capsule of KSM 66 Ashwagandha (300 mg) 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.

Dietary Supplement: Ashwagandha

Placebo

PLACEBO COMPARATOR

Placebo means that the capsules will not contain Ashwagandha but some other inactive substance. By using placebo, investigators will know whether the positive results are because of Ashwagandha or are because of psychological factors. For example, the participant may feel that his or her condition is improved because he or she is expecting the capsules to be helpful. After enrollment in the study, 50% of participants will be randomly assigned to take 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.

Other: Placebo

Interventions

Ashwagandha DIETARY_SUPPLEMENT

KSM-66 Ashwagandha is the active ingredient in Waithania somifera, a medicinal plant in Indian medicine. Ashwagandha is known as an adaptogen, an herb in capsule form that protects the body from stress.

Ashwagandha

Placebo OTHER

Placebo means that the capsules will not contain Ashwagandha but some other inactive substance.

Placebo

Eligibility Criteria

• Age: 30 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SF Research Institute, Inc.: lead

Study Sites (1)

San Francisco Research Institute

San Francisco, California, 94127, United States

RECRUITING

MeSH Terms

Interventions

Ashwagandha

Central Study Contacts

John Ademola

CONTACT

415-845-4638; jademola@sfinstitute.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 3, 2023
• Study Start: August 7, 2023
• Primary Completion: October 5, 2023
• Study Completion: October 12, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-04

Locations

US (1)