A Research Study on How Well and How Safe Astareal Oil Capsules Work for Male Sexual Problems
- Conditions
- Health Condition 1: N00-N99- Diseases of the genitourinary system
- Registration Number
- CTRI/2024/03/063530
- Lead Sponsor
- Astareal Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Males aged from 21 years to 60 years.
2. Clinically identified cases of sexual weakness, erectile dysfunction, Pre ejaculation,
Decrease in libido with not less than 3months.
3. Body weight in accordance with LIC table
4. Hematologic and biochemical parameters within normal limits
5. Willingness to sign consent for study including participation with collection of blood
specimens.
1.Individuals with established/known organic pathology for sexual weakness.
2. Patients receiving other hormonal treatments.
3.Patients with evidence of renal, hepatic or cardiac failure.
4. Patients with gastro-enteritis, diabetes and endocrine disorders.
5. Patients on long-term steroidal treatment.
6. Patients with other sexual disorders such as hypoactive sexual desire.
7. Not willing to sign informed consent form.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To evaluate the efficacy of Astareal oil capsule in Male Sexual Dysfunction & <br/ ><br>oligospermia. <br/ ><br> <br/ ><br>2.To compare the safety and efficacy of Astareal oil capsules with PlaceboTimepoint: In week 4 <br/ ><br> <br/ ><br>1.To assess the Efficacy of Astareal oil capsule in Male Sexual Dysfunction in 4th week. <br/ ><br>2. Rapid recovery from symptoms check in 4th week <br/ ><br> <br/ ><br>3. The change in score for Male Sexual Dysfunction domain score of <br/ ><br>the Sexual Function Questionnaire at 4th week <br/ ><br> <br/ ><br>4. Compare with the changes in Sexual Function Questionnaire for Male Sexual <br/ ><br>Dysfunction domain score between the study group and comparator group at 4 th week
- Secondary Outcome Measures
Name Time Method 1.To assess the safety profile of Astareal oil capsule in Male Sexual Dysfunction. <br/ ><br>2. To find out, incidence of adverse events during the study period, & overall compliance to <br/ ><br>the drug treatment.Timepoint: 1.To find out, incidence of adverse events during the study period & overall compliance to <br/ ><br>the drug treatment & at week 12. <br/ ><br> <br/ ><br>2.At week 12- evaluate treatment Adherence/Compliance.