Clinical TrialID 7784

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

NCT05840731

Sexual Health

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Record Fields

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Clinical Trial Id
7784
Evidence Id
7784
Core Evidence Id
7784
Source Clinical Trial Id
7777
Herb2 Clinical Trial Id
HBCT007777
Nct Id
NCT05840731
Title
Role of Ashwagandha Extract (Capsule KSM-66 300 mg) in Improving Sexual Health in Healthy Men
Status
Recruiting
Phase
Phase 4
Study Result
No
Study Condition
Sexual Health
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Intervention
DIETARY_SUPPLEMENT: Ashwagandha|OTHER: Placebo
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Double
Intervention Purpose
Supportive_Care
Gender
Male
Age
Adult
Enrollment
45
Outcome Measure
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
Sponsor Collaborator
SF Research Institute, Inc.
Funded By
NETWORK
Location
San Francisco Research Institute, San Francisco, California, 94127, United States
Other Id
Ixoreal-MSD-CT-01-22
Start Date
2023-08-07
Primary Completion Date
2023-10-05
Completion Date
2023-10-12
First Posted
2023-05-03
Results First Posted
Last Update Posted
2023-05-09
Study Document
Study Url
https://clinicaltrials.gov/study/NCT05840731
Title Cn
Title En
Role of Ashwagandha Extract (Capsule KSM-66 300 mg) in Improving Sexual Health in Healthy Men
Bilingual Status
semi_complete