the Effects of Different Therapy Regimens on Menopausal Sleep Disorders

• Status: Not yet recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Tibolone

Criteria

Inclusion Criteria:

• women aged 40-60

• natural menopause for 1-10 years

• PSQI score >=11 points

• improved K-score>=14 points

• able to independently sign informed consent forms

Exclusion Criteria:

• Vaginal bleeding of unknown cause

• Known or suspected breast cancer and other sex hormone dependent tumors

• Active venous or arterial thromboembolic disease within past 6 months

• Have used sex hormone or traditional Chinese medicine/botanical drugs that affect menopausal symptoms within the past month

• Have used anti anxiety, depression drugs or sedative hypnotics within the past month

• Patients with anxiety or depression above moderate level

• Severe liver or kidney dysfunction, with transaminase or creatinine level exceeding twice of the normal value

• BMI ≥ 28 kg/m2

• Allergies to research drugs

• Other situations that doctor deems unsuitable to participate in the study