A Research Study on How Well and How Safe Astareal Oil Capsules Work for Male Sexual Problems

Evaluation of Efficacy and Safety of Astareal oil Capsule in Male Sexual Dysfunction A Randomized ,Double blind - Placebo-controlled Comparative Study - NILL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063530

Enrollment

Registered

2024-03-04

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: N00-N99- Diseases of the genitourinary system

Interventions

Intervention1: Astareal oil Capsule: Capsule contains Oleoresin, Extracted from Haematococcus pluvialis algal biomass produced by using a solvent-free, Given 1 capsule twice daily supercritical CO2 ex

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1.To evaluate the efficacy of Astareal oil capsule in Male Sexual Dysfunction & oligospermia. 2.To compare the safety and efficacy of Astareal oil capsules with PlaceboTimepoint: In week 4 1.To assess the Efficacy of Astareal oil capsule in Male Sexual Dysfunction in 4th week. 2. Rapid recovery from symptoms check in 4th week 3. The change in score for Male Sexual Dysfunction domain score of the Sexual Function Questionnaire at 4th week 4. Compare with the changes in Sexual Function Questionnaire for Male Sexual Dysfunction domain score between the study group and comparator group at 4 th week	—

Measure

Time frame

1.To evaluate the efficacy of Astareal oil capsule in Male Sexual Dysfunction & oligospermia. 2.To compare the safety and efficacy of Astareal oil capsules with PlaceboTimepoint: In week 4 1.To assess the Efficacy of Astareal oil capsule in Male Sexual Dysfunction in 4th week. 2. Rapid recovery from symptoms check in 4th week 3. The change in score for Male Sexual Dysfunction domain score of the Sexual Function Questionnaire at 4th week 4. Compare with the changes in Sexual Function Questionnaire for Male Sexual Dysfunction domain score between the study group and comparator group at 4 th week

—

Secondary

Measure	Time frame
1.To assess the safety profile of Astareal oil capsule in Male Sexual Dysfunction. 2. To find out, incidence of adverse events during the study period, & overall compliance to the drug treatment.Timepoint: 1.To find out, incidence of adverse events during the study period & overall compliance to the drug treatment & at week 12. 2.At week 12- evaluate treatment Adherence/Compliance.	—

Countries

India

Contacts

Public ContactMothish waran

SRMIST, Interdisciplinary Institute of Indian system of Medicine

ayursatish@gmail.com9884845887

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026