NCT06117969

the Effects of Different Therapy Regimens on Menopausal Sleep Disorders

A Prospective Randomized Controlled Study of the Effects of Different Therapy Regimens on Menopausal Sleep Disorders

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Sleeping disorders are one of the most common menopausal symptoms, which seriously affect health and life quality of perimenopausal women. Menopausal hormone therapy is an effective treatment for menopausal symptoms, meanwhile, traditional Chinese medicine is also effective to some extent. This prospective randomized controlled study plan to compare the effects of different therapy regimens, including Tibolone and Xiangshao granules, on menopausal sleep disorders.

Conditions

• Menopause
• Sleep Disorder

Interventions

Type	Name	Description
DRUG	Tibolone	1.25mg po qd
DRUG	Xiangshao granules	4g po tid
DRUG	Tibolone plus Xiangshao granules	Tibolone 1.25mg po qd plus Xiangshao granules 4g po tid

Timeline

• Start date: 2023-12-30
• Primary completion: 2024-06-01
• Completion: 2025-09-30
• First posted: 2023-11-07
• Last updated: 2024-01-02