Recruiting

Ashwagandha Extract

Sponsor:

SF Research Institute, Inc.

Code:

NCT05840731

Conditions

Sexual Health

Eligibility Criteria

Sex: Male

Age: 30 - 50

Healthy Volunteers: Accepted

Interventions

Ashwagandha

Placebo

Study Details

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

Study ID

NCT05840731

Start date

Aug 7, 2023

Status verified date

Apr, 2023

Completion date

Oct 12, 2023

Anticipated

Primary completion date

Oct 5, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 30 - 50

Healthy Volunteers: Accepted

Inclusion 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Ashwagandha

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.

placebo comparator: Placebo

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.

Interventions

Ashwagandha

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.

Placebo

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

Primary outcome measure

  • Number of Satisfying Sexual Events (SSEs) [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

John Ademola

415-845-4638jademola@sfinstitute.com

Locations

San Francisco Research Institute

Recruiting

San Francisco, California, United States, 94127

Contacts

John Ademola, PhD

415-845-4638jademola@sfinstitute.com

More Information

Sponsor

SF Research Institute, Inc.

Last update posted

May 9, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by SF Research Institute, Inc. on 2023-05-09.