the Effects of Different Therapy Regimens on Menopausal Sleep Disorders

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Not yet enrolling; Phase 4

Conditions: Menopause; Sleep Disorder

Treatments: Drug: Tibolone plus Xiangshao granules; Drug: Xiangshao granules; Drug: Tibolone

Study type: Interventional

Funder types: Other

Identifiers

NCT06117969

menopausal sleep disorders

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Tibolone

Experimental group

Description:

take Tibolone 1.25mg/day orally for 8 weeks

Treatment:

Drug: Tibolone

Xiangshao granules

Experimental group

Description:

take Xiangshao granules orally 3 times a day, 4g each time

Treatment:

Drug: Xiangshao granules

Tibolone plus Xiangshao granules

Experimental group

Description:

take Tibolone 1.25mg/day and Xiangshao granules 3 times a day, 4g each time orally for 8 weeks

Treatment:

Drug: Tibolone plus Xiangshao granules