Efficacy of a Multi-Herb Thai Traditional Preparation for Erectile Dysfunction in Elderly Men: Double-Blind Randomized Controlled Trial

Phase 2

Completed

• Conditions: 5; Erectile Dysfunction; Efficacy; Double- blind; Traditional Thai Preparation; Sao Thong Tai; IIEF- QSF; PSQI

• Registration Number: TCTR20180126001
• Lead Sponsor: none

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-26
• Study Completion: 2018-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 54

Inclusion Criteria

married men between 50-69 years old or those with stable chronic medical illnesses, such as, controlled diabetes mellitus and/or hypertension. Besides, those suffering from ED symptoms at least 6 months, having stable heterosexual relationship for at least 6 months, both partners agreeing to attempt intercourse at least once a week on average during the study, and those with bioavailable testosterone 40-190 ng/dL and IIEF-5 score 11-21 (mild to moderate ED) are also included. Participants with the following conditions are excluded: history of major hematological, renal or hepatic disorder, stroke or myocardial infraction and cardiovascular disease within the last six months, peptic ulcer or bleeding disorder, history of prostate cancer, elevated prostate specific antigen (PSA ≥ 4 ng/ ml), major uncontrolled psychiatric disorder, penile anatomical abnormalities, primary hypoactive sexual desire, history of alcohol or drug abuse, resting hypotension (resting systolic blood pressure < 90 mmHg or diastolic pressure < 50 mmHg), resting hypertension (resting systolic blood pressure > 170 mmHg or diastolic pressure > 110 mmHg), body mass index BMI over 30 kg per m2, using herbal products or drugs that contain testosterone or any androgenic activity in the last month before the trial starts, Thyroid stimulating hormone TSH,T3,T4.

Exclusion Criteria

Abnormal and history of herbal allergy. However, during the study period, participants who experience abnormal prostate exam during the screening visit study controls and are unable to comply with the scheduled treatment dose of at least 80% of the dose are terminated.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Erectile Dysfunction at 12 weeks after end of the intervention Scores of International Index of Erectile Function and Scale for Quality of Sexual Function ,Qualitative 12 weeks The sleep quality is assessed by the Pittsburgh Sleep Quality Index (PSQI)

Secondary Outcome Measures

Name	Time	Method
Safety 8 weeks physical examination, clinical and laboratory test