A clinical trial of Aswagandha and Shilajit in male sexual dysfunction due to mild to moderate stress disorders

A double blind, randomized, placebo controlled clinical trial of Aswagandha (Withania somnifera) and Shilajit in male sexual dysfunction with special reference to erectile dysfunction and premature ejaculation due to mild to moderate stress disorders - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078369

Enrollment

Registered

2024-12-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: F451- Undifferentiated somatoform disorder

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: (a) male, age 25-60 years, (b) Predominant complain of sexual disorders with special emphasis on ED & PME (c) Associate complaint is anxiety, depression, or sleep disturbances related to chronic stress (d) Patient fulfill most of the criteria of DHS, PEDT, EHS, IIEF-5, PSS, HAM-A and HAM-D

Exclusion criteria

Exclusion criteria: (a) Anticipation of any change in stressors or life events, (b) Any clinically significant medical or psychiatric symptoms, (c) Patient already received any kind of aphrodisiac drugs, (d) Presence of unstable major medical comorbidity such as diabetes, hypertension, ischemic heart disease, and neuropsychiatric disease

Design outcomes

Primary

Measure	Time frame
i) To detect male sexual disorders and its specificity due to stress ii) To determine efficacy of the root extracts of Aswagandha (W. somnifera) and Shilajit for male sexual disorders with special emphasis on erectile dysfunction (ED) and pre-mature ejaculation (PME) Timepoint: 8 weeks	—

Secondary

Measure	Time frame
i) To determine safety aspect of the root extracts of Aswagandha (W. somnifera) and Shilajit ii) To determine efficacy of the root extracts of Aswagandha (W. somnifera) and Shilajit with special emphasis on the level of serum cortisol, testosterone, FSH and LH iii) To determine sexual dysfunction in male patient and determination of efficacy of the root extracts of Aswagandha (W. somnifera) and Shilajit on the basis of Dhat Syndrome Questionnaire (DHS), Premature Ejaculation Diagnostic Tools (PEDT), Erection Hardness Scale (EHS), Sexual Desire and Aversion (DESEA), IIEF-5, Perceived Stress Scale (PSS), Hamilton’s Anxiety Scale (HAM-A) and Hamilton’s Depression Scale (HAM-D) Timepoint: 8 weeks	—

Measure

Time frame

i) To determine safety aspect of the root extracts of Aswagandha (W. somnifera) and Shilajit ii) To determine efficacy of the root extracts of Aswagandha (W. somnifera) and Shilajit with special emphasis on the level of serum cortisol, testosterone, FSH and LH iii) To determine sexual dysfunction in male patient and determination of efficacy of the root extracts of Aswagandha (W. somnifera) and Shilajit on the basis of Dhat Syndrome Questionnaire (DHS), Premature Ejaculation Diagnostic Tools (PEDT), Erection Hardness Scale (EHS), Sexual Desire and Aversion (DESEA), IIEF-5, Perceived Stress Scale (PSS), Hamilton’s Anxiety Scale (HAM-A) and Hamilton’s Depression Scale (HAM-D) Timepoint: 8 weeks

—

Countries

India

Contacts

Public ContactDr Tuhin Kanti Biswas

Raghunath Ayurved Mahavidyalaya and Hospital

jbrtkbiswas@gmail.com9433173272

Outcome results