Effects of Ashwagandha Extract (Capsule KSM-66 300 mg) on Sexual Health in Healthy Women

NCT05831241 | Completed

• 1 other identifier: Ixoreal-FSD-CT-10-22
• 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 Women by measuring the sex hormone levels in blood, analyzing results of questionnaires, and monitoring adverse events in the post-marketing phase. Changes in 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 improvements in results or scores in assessment questionnaires.

Conditions

Sexual Health

Outcome Measures

Primary Outcomes (1)

• Female Sexual Function Index (FSFI)

  FSFI questions are coded from 0.0 to 5.0. Based on clinical considerations, the scale is considered to have six sexual domains: desire, arousal, lubrication, orgasm, satisfaction, pain. Each domain is contributing to the overarching construct of female sexual function. The maximum score for each domain is 6.0, obtained by summing item responses and multiplying by a correction factor. The total composite sexual function score is a sum of domain scores and ranges from 2.0 (not sexually active and no desire) to 36.0. A higher score means a better outcome.

  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% 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 subject may feel that her condition is improved because she is expecting the capsules to be helpful. After enrollment in the study, 50% 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: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants between 18 to 55 years of age.
• Female participants having regular menstrual periods.
• Participants with a baseline total score of 11 to 26 on the FSFI.
• The participate should inform their partner about the study
• Her partner should be willing to let her participate in the study
• Participants in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 6 months prior to the Screening Visit.
• Participant's partner is expected to be physically present at least 50% of each month.
• Participants who have used a medically acceptable method of contraception for at least 3 months before the baseline Visit (Visit 1) and continue to use that medically acceptable method of contraception during the trial. Medically acceptable methods of contraception 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) vasectomized partner (f) male or female condom with or without spermicide. (g) diaphragm with spermicide. (h) cervical cap with spermicide. (i) vaginal sponge with spermicide. (j) progesterone only oral hormonal contraception.
• 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 or LAR can and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
• 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 willing to have 4 or more attempts of sexual intercourse regularly each month.

You may not qualify if:

• Participants who are not willing to take an investigational product.
• Any acute illness which may hamper the study participation as per principal investigator discretion at the time of enrollment.
• Participants having any clinically significant medical history, medical finding or an on-going medical or psychiatric condition exists 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 current alcohol or drug addiction or with a history of drug dependence or abuse within the past one year.
• Participants who meet accepted diagnostic criteria for sexual disorders that would interfere with improvement in Hypoactive Sexual Desire Disorder (HSDD) (sexual aversion, substance- induced sexual problems, urge to live as a man, etc.
• Participants who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the Subjects response to treatment.
• Participants who have entered the menopausal transition or menopause or have had a hysterectomy.
• Participants with findings of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female genital organs, at the Screening Visit.
• Participants who are breastfeeding or have breastfed within the last 6 months prior to the Baseline Visit.
• Participants who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.
• Participants having primary hypoactive sexual desire.
• Participants with a history of malignancy.
• Participant herself is not planning to get pregnant for next six months

Sponsors & Collaborators

• SF Research Institute, Inc.: lead

Study Sites (1)

San Francisco Research Institute

San Francisco, California, 94127, United States

Location

MeSH Terms

Interventions

Ashwagandha

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: April 26, 2023
• Study Start: July 12, 2023
• Primary Completion: October 12, 2023
• Study Completion: December 20, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

US (1)