the Effects of Different Therapy Regimens on Menopausal Sleep Disorders

NCT06117969 | Unknown Phase 4

• 1 other identifier: menopausal sleep disorders
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Menopause; Sleep Disorder

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (4)

• Improved Kupperman score

  V0(screening period), V2(week 4), V3(week 8)

• Menopause-specific Quality of Life Scale

  V0(screening period), V2(week 4), V3(week 8)

• Self-Rating Anxiety Scale

  V0(screening period), V2(week 4), V3(week 8)

• Center for Epidemiological Survey Depression Scale (CES Depression Scale)

  V0(screening period), V2(week 4), V3(week 8)

Study Arms (3)

Tibolone

EXPERIMENTAL

take Tibolone 1.25mg/day orally for 8 weeks

Drug: Tibolone

Xiangshao granules

EXPERIMENTAL

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

Drug: Xiangshao granules

Tibolone plus Xiangshao granules

EXPERIMENTAL

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

Drug: Tibolone plus Xiangshao granules

Interventions

Tibolone DRUG

1.25mg po qd

Tibolone

Xiangshao granules DRUG

4g po tid

Xiangshao granules

Tibolone plus Xiangshao granules DRUG

Tibolone 1.25mg po qd plus Xiangshao granules 4g po tid

Tibolone plus Xiangshao granules

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Related Publications (7)

• 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.

  PMID: 12628216 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.

  PMID: 10981461 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.

  PMID: 28875581 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.

  PMID: 28522086 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.

  PMID: 15883105 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.

  PMID: 29071997 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.

  PMID: 33016149 BACKGROUND

Related Links

• 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

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

tibolone

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Rong Chen, Professor

  Peking Union Medical College Hospital

  STUDY DIRECTOR

Central Study Contacts

Rong Chen, Professor

CONTACT

010-13811030947; chenrongpumch@163.com

Lingjin Yang

CONTACT

010-15650795133; yanglingjin0803@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 7, 2023
• Study Start: December 30, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 30, 2025
• Last Updated: January 2, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share