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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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial investigates the effects of KSM66 Ashwagandha extract on women's sexual health through hormone levels, questionnaire results, and adverse events.

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
Female Sexual Function Index (FSFI)

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% 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 Group2 Interventions
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.
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

Frequently Asked Questions

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

Are individuals over the age of thirty-five welcome to participate in this clinical experiment?

"For this trial, only individuals over the age of 18 and under 55 years old are eligible for enrollment."

Answered by AI

Has the Food and Drug Administration sanctioned Ashwagandha for medicinal use?

"Our team at Power assigned ashwagandha a score of 3 since it has progressed to the fourth stage in clinical trials, which is indicative that this medication is approved."

Answered by AI

Are there still opportunities for enrolment in this experiment?

"Affirmative, the information from clinicaltrials.gov confirms that this medical study is recruiting patients at present; it was initially advertised on May 15th 2023 and updated most recently on April 14th 2023. 45 individuals are required to be recruited for the experiment from a single trial site."

Answered by AI

What is the number of participants involved in this research endeavor?

"Affirmative. According to the information made available on clinicaltrials.gov, this medical research endeavor is currently looking for participants - 45 of them at one site specifically. The trial was first established in May 15th 2023 and modified on April 14th 2023."

Answered by AI

Could I potentially qualify for participation in this medical study?

"This medical trial has 45 openings and seeks participants with sexual health who are between 18-55 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effects of Ashwagandha Extract (Capsule KSM-66 300 mg) on Sexual Health in Healthy Women
2023. "Effects of Ashwagandha Extract (Capsule KSM-66 300 mg) on Sexual Health in Healthy Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05831241.
~25 spots leftby Apr 2025
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