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Efficacy and safety of Cappra in erectile dysfunction patients

Efficacy and safety of Cappra in mild to moderate erectile dysfunction patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN53582859
Enrollment
70
Registered
2012-05-28
Start date
2011-06-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Mild and mild to moderate erectile dysfunction patients Mental and Behavioural Disorders Failure of genital response

Interventions

Patients received information regarding the study protocol, its rationale and the potential risks (in Thai language) as well as six tablets, divided into two packages: three tablets of Cappra and thre
a wash-out period of 7 days was necessary between the first and second period. The other group received both Cappra and placebo at the same manner as the first group but in the opposite order to the f

Sponsors

CAPP Innovation Research and Development Center (CIRD) (Thailand)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Men aged 35 and above with mild and mild to moderate erectile dysfunction analyzed according to the International Index of Erectile Function-5 (IIEF-5) 2. All subjects must be sexually active and have sexual intercourse at least three times within 2 weeks

Exclusion criteria

Exclusion criteria: 1. Patients with uncontrolled hypertension or uncontrolled diabetes mellitus within 3 months before enrollment into the study 2. Patients with liver or kidney dysfunction 3. Patients with active upper gastrointestinal bleeding 4. Patients who use any medications which may affect sexual function such as testosterone, phosphodiesterase type 5 inhibitor or any herbal substances claimed for improving sexual function 5. Patients who take medications which may have an interaction with Cappra, such as warfarin, antiplatelet agents, potassium sparing diuretics, monoamine oxidase inhibitors, and selective serotonin reuptake inhibitors 6. Patients who allergic to sulfonamide 7. Patients who allergic to honey or bee pollen 8. Patients with speech or reading problems 9. Participants also left the project when they could not comply with the study protocol, were unwilling to continue with the study or when the physician opined that patients may be harmed by the study protocol

Design outcomes

Primary

MeasureTime frame
The difference of the score from International Index of Erectile Function-5 (IIEF-5) self-questionnaire before and after taking the medications. They must fill the same questionnaire three times, which are at the time of enrollment to this study, at the end of the first period and at the end of the second period.

Secondary

MeasureTime frame
Adverse reaction or side effects experienced after taking Cappra. All adverse reactions will be analyzed by Nanranjo's algorithm to identify whether Cappra was the cause of those adverse reactions.

Countries

Thailand

Outcome results

None listed

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