the Effects of Different Therapy Regimens on Menopausal Sleep Disorders

Study Overview
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Brief Summary
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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.

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

Conditions
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Menopause, Sleep Disorder

Intervention / Treatment
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* Drug: Tibolone
* Drug: Xiangshao granules
* Drug: Tibolone plus Xiangshao granules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women aged 40-60 natrual 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tibolone<br>take Tibolone 1.25mg/day orally for 8 weeks | Drug: Tibolone<br>* 1.25mg po qd<br>|
| Experimental: Xiangshao granules<br>take Xiangshao granules orally 3 times a day, 4g each time | Drug: Xiangshao granules<br>* 4g po tid<br>|
| Experimental: Tibolone plus Xiangshao granules<br>take Tibolone 1.25mg/day and Xiangshao granules 3 times a day, 4g each time orally for 8 weeks | Drug: Tibolone plus Xiangshao granules<br>* Tibolone 1.25mg po qd plus Xiangshao granules 4g po tid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnography | 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). | V0(screening period), V3(week 8) | 
| PSQI questionnaire | The total score of PSQI questionnaire is 0-21 points. Normal sleep quality is defined as less than 11 points. | V0(screening period), V2(week 4), V3(week 8) | 
| Sleep diary | Sleep diary is recorded by study participants daily. | V0(screening period), V1（dsy 1）, V2(week 4), V3(week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Kupperman score | The total score of improved K score is graded into four levels: nomal(<7), mild(7-14), moderate(15-29), severe(>30). | V0(screening period), V2(week 4), V3(week 8) | 
| Menopause-specific Quality of Life Scale | Evaluate vasomotor symptoms, psychological and emotional symptoms, physical symptoms and sexual activity symptoms. | V0(screening period), V2(week 4), V3(week 8) | 
| Self-Rating Anxiety Scale | 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. | V0(screening period), V2(week 4), V3(week 8) | 
| Center for Epidemiological Survey, Depression Scale | The total score of CES-D is graded into three levels: asymptomatic(<15), possible depressive symptoms(16-19), exsisted depressive symptoms(≥20) | V0(screening period), V2(week 4), V3(week 8) |