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Effect Of Ashwagandha on Male Sexual Health

Efficacy and Safety of Ashwagandha (Withania Somnifera ) Root Powder on Male Sexual Health: A Double-Blind Randomized Placebo-Controlled Study

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039243
Enrollment
60
Registered
2022-01-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: N468- Other male infertility

Interventions

None listed

Sponsors

Ayurvedic and Unani Tibbia College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male patient Aged >=20 to 2. Subject satisfying any one of the following criteria. • Subject having Erectile dysfunction IIEF A Score in between 11-21. • Premature Ejaculation IPE Score in between 18-28. • Other Sexual dysfunction IIEF B Score in between 21-30. 2. Not suffering from any chronic disease. 3. Patients have common medical co-morbidities. • Controlled hypertension ( • Controlled diabetes (FBS<=126mg/dl/ PP<=200mg/dl or HbA1c between 6-6.9 %).

Exclusion criteria

Exclusion criteria: 1. History of hypothyroidism, cardiovascular disease, psychiatric disorders. 2. Participants addicted to smoking, tobacco and alcohol consumption. 3. Subject under treatment for the male infertility. 4. Anatomical deformity of the penis such as severe penile fibrosis or Peyronieâ??s disease or phimosis. 5. Subjects suffering from congenital anomalies. 6. Subjects who underwent major surgical procedures in last 6 months. 7. Subjects with any unstable heart disease or known case of MI, Unstable angina. 8. Subjects who have completed participation in any other clinical trial during the past six month.

Design outcomes

Primary

MeasureTime frame
Improvement in any of the following questionnaire score. a) International Index of Erectile function subscale A b) International Index of Erectile function subscale B c) Index of Premature EjaculationTimepoint: 30 days

Secondary

MeasureTime frame
The secondary outcome is the improvement in the semen parameters and serum testosterone level from baseline (day 0) after 30 days of therapy. Timepoint: 30 days

Countries

India

Contacts

Public ContactDr Sujata Rajan

Ayurvedic and Unani Tibbia College and Hospital

sujataa.rajan@gmail.com9354925026

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026