Condition category
Mental and Behavioural Disorders
Date applied
20/05/2012
Date assigned
28/05/2012
Last edited
26/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Several medications for the treatment of erectile dysfunction are on the market nowadays. However, those medications may have a strong reaction or side effects in patients with certain conditions such as heart or coronary diseases. Herbal substances may be an alternative. Cappra is registered in Thailand as a herbal medication. Its ingredients have been proven to be safe and have been used in Chinese medication for decades. The aim of this study is to find out whether Cappra is effective and safe for the treatment of erectile dysfunction.

Who can participate?
Men aged 35 and above with erectile dysfunction.

What does the study involve?
Patients were randomly allocated into two groups. The patients in the first group received three tablets of Cappra during the first 2-weeks period and three placebo (dummy) tablets during the second 2-week period, with a 7-day break in between the first and second periods. The other group received both Cappra and placebo but in the opposite order to the first group. All patients were instructed to take one tablet of either Cappra or placebo 1 hour before sexual intercourse and they had to take three tablets within 2-week period.

What are the possible benefits and risks of participating?
Patients may benefit from improved sexual ability but may have some risks of side effects such as dizziness, fatigue or muscle cramp.

Where is the study run from?
This study was mainly performed at Faculty of Pharmaceutical Sciences, Chulalongkorn University in Bangkok, Thailand.

When is the study starting and how long is it expected to run for?
The study ran from June 2011 to April 2012.

Who is funding the study?
This study was funded by CAPP Innovation Research and Development Center (CIRD) (Thailand).

Who is the main contact?
Associate Professor Pornanong Aramwit
annablee@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pornanong Aramwit

ORCID ID

Contact details

Department of Pharmacy Practice
Faculty of Pharmaceutical Sciences
Chulalongkorn University
Bangkok
10330
Thailand

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

03/55

Study information

Scientific title

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

Acronym

Study hypothesis

Cappra (a Chinese herbal medicine) is efficient and safe for the treatment of mild and mild to moderate erectile dysfunction.

Ethics approval

Joint Research Ethics Committee in Bangkok, Thailand, 02/01/2011, ref: JREC 013/53

Study design

Randomized double-blind placebo-controlled two-period cross-over design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mild and mild to moderate erectile dysfunction patients

Intervention

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 three tablets of placebo, for use during the study period.

The patients were randomized into two groups using a computer-generated random sampling table in which the identity of those in each group was concealed from both the investigators and patients. The patients in the first group received three tablets of Cappra during the first period (2 weeks) and three tablets of placebo during the second period; 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 first group. All patients were instructed to take one tablet of either Cappra or placebo 1 hour before sexual intercourse and they had to take three tablets within the 2-week period.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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.

Overall trial start date

01/06/2011

Overall trial end date

30/04/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

70 patients

Participant 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

Recruitment start date

01/06/2011

Recruitment end date

30/04/2012

Locations

Countries of recruitment

Thailand

Trial participating centre

Department of Pharmacy Practice
Bangkok
10330
Thailand

Sponsor information

Organisation

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

Sponsor details

12 Rama II
Soi. 24 Bang Mod
Chom Thong
Bangkok
10150
Thailand

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

CAPP Innovation Research and Development Center (CIRD) (Thailand), ref: CIRD 11/54

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes