the Effects of Different Therapy Regimens on Menopausal Sleep Disorders
- Conditions
- MenopauseSleep Disorder
- Interventions
- Registration Number
- NCT06117969
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 180
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Xiangshao granules Xiangshao granules take Xiangshao granules orally 3 times a day, 4g each time Tibolone plus Xiangshao granules Tibolone plus Xiangshao granules take Tibolone 1.25mg/day and Xiangshao granules 3 times a day, 4g each time orally for 8 weeks Tibolone Tibolone take Tibolone 1.25mg/day orally for 8 weeks
- Primary Outcome Measures
Name Time Method Polysomnography (PSG) V0(screening period), V3(week 8) Extract PSG EEG data: record time, bed time, sleep time, awakening time, rapid eye movement sleep time (REM), non rapid eye movement sleep time (NREM), non rapid eye movement sleep phase 1 (N1), non rapid eye movement sleep phase 2 (N2), non rapid eye movement sleep phase 3 (N3), total sleep time (TST), sleep latency (SL), wake after sleep onset (WASO), sleep efficiency (SE).
Pittsburgh Sleep QualityIndex questionnaire (PSQI questionnaire) V0(screening period), V2(week 4), V3(week 8) The total score of PSQI questionnaire is 0-21 points. Normal sleep quality is defined as less than 11 points.
Sleep diary V0(screening period), V1（dsy 1）, V2(week 4), V3(week 8) Sleep diary is recorded by study participants daily.
- Secondary Outcome Measures
Name Time Method Menopause-specific Quality of Life Scale V0(screening period), V2(week 4), V3(week 8) Evaluate vasomotor symptoms, psychological and emotional symptoms, physical symptoms and sexual activity symptoms. Choose a level from "0-6" based on the degree to which this symptom affects subject. ''0'' means it doesn't affect subject at all; ''6'' indicates extreme impact on subject.
Self-Rating Anxiety Scale V0(screening period), V2(week 4), V3(week 8) Assess anxiety level over the past two weeks. The evaluation adopts a 1-4 scoring system, where the scores of 20 questions are added together to obtain the total score. The total score is multiplied by 1.25 and rounded to the nearest whole number to obtain the standard score. The cut-off value of SAS standard score is 50 points, with a score of 50-59 indicating mild anxiety, 60-69 indicating moderate anxiety, and a score above 70 indicating severe anxiety.
Center for Epidemiological Survey Depression Scale (CES Depression Scale) V0(screening period), V2(week 4), V3(week 8) The total score of CES-D is graded into three levels: asymptomatic(\<15), possible depressive symptoms(16-19), existed depressive symptoms(≥20)
Improved Kupperman score V0(screening period), V2(week 4), V3(week 8) The total score of improved K score is graded into four levels: normal(\<7), mild(7-14), moderate(15-29), severe(\>30).