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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tibolone | Experimental | take Tibolone 1.25mg/day orally for 8 weeks |
|
| Xiangshao granules | Experimental | take Xiangshao granules orally 3 times a day, 4g each time |
|
| Tibolone plus Xiangshao granules | Experimental | take Tibolone 1.25mg/day and Xiangshao granules 3 times a day, 4g each time orally for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tibolone | Drug | 1.25mg po qd |
| |
| Xiangshao granules |
| Measure | Description | Time Frame |
|---|---|---|
| Polysomnography (PSG) | 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) |
| Pittsburgh Sleep QualityIndex questionnaire (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) |
| Measure | Description | Time Frame |
|---|---|---|
| Improved Kupperman score | The total score of improved K score is graded into four levels: normal(<7), mild(7-14), moderate(15-29), severe(>30). | V0(screening period), V2(week 4), V3(week 8) |
| Menopause-specific Quality of Life Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rong Chen, Professor | Contact | 010-13811030947 | chenrongpumch@163.com | |
| Lingjin Yang | Contact | 010-15650795133 | yanglingjin0803@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Rong Chen, Professor | Peking Union Medical College Hospital | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12628216 | Background | Moline ML, Broch L, Zak R, Gross V. Sleep in women across the life cycle from adulthood through menopause. Sleep Med Rev. 2003 Apr;7(2):155-77. doi: 10.1053/smrv.2001.0228. | |
| 10981461 | Background | Gold EB, Sternfeld B, Kelsey JL, Brown C, Mouton C, Reame N, Salamone L, Stellato R. Relation of demographic and lifestyle factors to symptoms in a multi-racial/ethnic population of women 40-55 years of age. Am J Epidemiol. 2000 Sep 1;152(5):463-73. doi: 10.1093/aje/152.5.463. |
| Label | URL |
|---|---|
| Guideline for the evaluation and treatment of insomnia in Chinese adults(2017) | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 6, 2023 | Oct 18, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C027385 | tibolone |
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| Drug |
4g po tid |
|
| Tibolone plus Xiangshao granules | Drug | Tibolone 1.25mg po qd plus Xiangshao granules 4g po tid |
|
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.
| 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. 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. | V0(screening period), V2(week 4), V3(week 8) |
| Center for Epidemiological Survey Depression Scale (CES Depression Scale) | The total score of CES-D is graded into three levels: asymptomatic(<15), possible depressive symptoms(16-19), existed depressive symptoms(≥20) | V0(screening period), V2(week 4), V3(week 8) |
| 28875581 | Background | Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5. |
| 28522086 | Background | Kaplan KA, Hardas PP, Redline S, Zeitzer JM; Sleep Heart Health Study Research Group. Correlates of sleep quality in midlife and beyond: a machine learning analysis. Sleep Med. 2017 Jun;34:162-167. doi: 10.1016/j.sleep.2017.03.004. Epub 2017 Mar 27. |
| 15883105 | Background | Kenemans P, Speroff L; International Tibolone Consensus Group. Tibolone: clinical recommendations and practical guidelines. A report of the International Tibolone Consensus Group. Maturitas. 2005 May 16;51(1):21-8. doi: 10.1016/j.maturitas.2005.02.011. |
| 29071997 | Background | Jiang XR, Ren L, Li CR. [Effect of Electroacupuncture on Hypothalamus-Pituitary-Ovary (HPO) Axis in Rats with Peri-menopausal Depression]. Zhen Ci Yan Jiu. 2017 Feb 25;42(1):45-9. Chinese. |
| 33016149 | Background | Chen R, Tang R, Zhang S, Wang Y, Wang R, Ouyang Y, Xie X, Liu H, Lv S, Shi H, Zhang Y, Xie M, Luo Y, Yu Q. Xiangshao granules can relieve emotional symptoms in menopausal women: a randomized controlled trial. Climacteric. 2021 Jun;24(3):246-252. doi: 10.1080/13697137.2020.1820476. Epub 2020 Oct 5. |
| The 2023 Chinese menopause symptom management and menopausal hormone therapy guidelines | View source |
| Curative Effect Analysis on Xiang Shao Particle in the Treatment of Women Perimenopausal Syndrome | View source |
| Efficacy and safety of Jingqianping granule in treatment of 403 cases of the liver-qi invasion of premenstrual syndrome with multicentre, random,double-blind and double simulation and control method | View source |
| D001523 | Mental Disorders |