Clinical study of juzentaihoto on Late Onset Hypogonadism

JRCT ID: jRCT1061200053

Registered date:08/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Late onset hypogonadism
• Date of first enrollment: 06/05/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Tsumura Juzentaihoto 2.5 g given aftermeals or between meals 3 times per day for 56 days. The dosage and the number of administration of the drug are modified according to the age, body weight, and symptoms of the patients.

Outcome(s)

• Primary Outcome: 1. Changes in blood free testosterone level

Secondary Outcome

1. Changes in Aging males' symptom (AMS) score, Self-rating Depression Scale (SDS), F scle (FSSG) after 8 weeks of intervention.
2. Changes in Kampo medical conditions score after 8 weeks of intervention.
3. Adverse event caused by Tsumura Juzentaihoto.

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: <= 74age old
• Gender: Male

Include criteria

1. Male between the age of 30 and 74
2. Blood free testosterone level is below normal range and diagnosed as late onset hypogonadism
3. Not having past history of gonadal failure
4. Androgen replacement therapy (ART) is not applicable
5. Written informed consent

Exclude criteria

1. Past history of adverse event by the drug used in this study
2. Judged by researchers to be inappropriate as a study subject

Related Information

• Primary Sponsor: Ueda Keigo