← Back to Search

Adaptogen

Ashwagandha for Sexual Wellness

Phase 4
Recruiting
Research Sponsored by SF Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 who are willing to have 4 or more attempts of sexual intercourse each month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial tests an herbal extract to improve sexual health in men, measuring hormone levels and assessing how it affects sexual satisfaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Men between 30 and 50 years old who have been feeling unsatisfied with their sexual experiences for at least the past 3 months.
Select...
You are willing to have sex at least 4 times every month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Satisfying Sexual Events (SSEs)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AshwagandhaExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ashwagandha
2017
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

SF Research Institute, Inc.Lead Sponsor
4 Previous Clinical Trials
395 Total Patients Enrolled

Media Library

Ashwagandha Extract (Adaptogen) Clinical Trial Eligibility Overview. Trial Name: NCT05840731 — Phase 4
Sexual Wellness Research Study Groups: Ashwagandha, Placebo
Sexual Wellness Clinical Trial 2023: Ashwagandha Extract Highlights & Side Effects. Trial Name: NCT05840731 — Phase 4
Ashwagandha Extract (Adaptogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05840731 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants over 30 years of age eligible for this research?

"This clinical trial is available to individuals aged 30-50 years old."

Answered by AI

Has the Food and Drug Administration verified the efficacy of Ashwagandha?

"Ashwagandha has been approved by the Phase 4 trial, so its safety rating is assessed at a 3."

Answered by AI

Is this medical study accepting new participants?

"Per the information on clinicaltrials.gov, this research is actively recruiting participants. It was first advertised in July of 2023 and its most recent update occurred at the end of April that year."

Answered by AI

Who qualifies to participate in this investigation?

"Applicants hoping to participate in this experiment must satisfy the criteria of sexual wellness and be aged between 30 and 50 years. The total number of candidates accepted is 45."

Answered by AI

What is the scope of enrolment for this clinical trial?

"Affirmative. According to information posted on clinicaltrials.gov, this research study is still searching for participants with an initial post date of July 10th 2023 and a most recent edit occurring April 30th 2023. 45 individuals need to be recruited from just one medical centre."

Answered by AI
~28 spots leftby Mar 2025