the Effects of Different Therapy Regimens on Menopausal Sleep Disorders
NCT ID: NCT06117969
Last Updated: 2024-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
180 participants
INTERVENTIONAL
2023-12-30
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tibolone
take Tibolone 1.25mg/day orally for 8 weeks
Tibolone
1.25mg po qd
Xiangshao granules
take Xiangshao granules orally 3 times a day, 4g each time
Xiangshao granules
4g po tid
Tibolone plus Xiangshao granules
take Tibolone 1.25mg/day and Xiangshao granules 3 times a day, 4g each time orally for 8 weeks
Tibolone plus Xiangshao granules
Tibolone 1.25mg po qd plus Xiangshao granules 4g po tid
Interventions
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Tibolone
1.25mg po qd
Xiangshao granules
4g po tid
Tibolone plus Xiangshao granules
Tibolone 1.25mg po qd plus Xiangshao granules 4g po tid
Eligibility Criteria
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Inclusion Criteria
* natural menopause for 1-10 years
* PSQI score \>=11 points
* improved K-score\>=14 points
* able to independently sign informed consent forms
Exclusion Criteria
* 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
40 Years
60 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Rong Chen, Professor
Role: STUDY_DIRECTOR
Peking Union Medical College Hospital
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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Guideline for the evaluation and treatment of insomnia in Chinese adults(2017)
The 2023 Chinese menopause symptom management and menopausal hormone therapy guidelines
Curative Effect Analysis on Xiang Shao Particle in the Treatment of Women Perimenopausal Syndrome
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
Other Identifiers
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menopausal sleep disorders
Identifier Type: -
Identifier Source: org_study_id
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