Study to evaluate the efficacy and safety of KSM- 66 Ashwagandha on sexual wellness of healthy male subjects

A randomized double blind placebo controlled comparative study to evaluate the effect of KSM- 66 Ashwagandha (Withania Somnifera) on Sexual Wellness of Healthy Male Subjects

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/05/006906

Enrollment

Registered

2016-05-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: KSM-66 Ashwagandha (Withania Somnifera): 300 mg twice daily orally with Milk/water in morning and Night for a period of 8 weeks Control Intervention1: Placebo: 300 mg twice daily orally

Eligibility

Inclusion criteria

Inclusion criteria: • Male subjects above 21 to 45 years of age and willing to give written inform Consent • Ready for monogamous relationship for the study period • No Significant Medical History • Ability to understand the risks and benefits of the protocol

Exclusion criteria

Exclusion criteria: • Subject with Medical History Interfering with the results of the history. • Subjects already on Aphrodisiac / Energy supplements • Subjects /couples planning their family by IVF/Alternate methods • Subject diagnosed with heart disease, diabetes, stroke or other neurological disorders or depression; • Subject with significant medication use (blood pressure, beta-blockers, inhaled beta agonists, hormonal contraceptives, corticosteroid use within prior three months, psychotropic medication use within prior eight weeks; • Subject with psychiatric hospitalization within past year • Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol

Design outcomes

Primary

Measure	Time frame
Improvement in Derogatis Interview for sexual functioning questionnaire after 3 weeks from randomizationTimepoint: 3 weeks from randomized into the study	—

Secondary

Measure	Time frame
ï? Improvement in serum testosterone and prolactin levels from baseline to end of therapy and quality of lifeTimepoint: baseline to end of therapy 8 weeks	—

Countries

India

Contacts

Public ContactPawan Bhusari

Shre Karthikeya Pharma

drsouvik@ixoreal.com914023204385

Outcome results