the Effects of Different Therapy Regimens on Menopausal Sleep Disorders

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06117969
• Other study ID #: menopausal sleep disorders
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 30, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: October 2023
• Source: Peking Union Medical College Hospital
• Contact: Rong Chen, Professor
• Phone: 010-13811030947
• Email: chenrongpumch[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: September 30, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

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

Related Conditions & MeSH terms

• Menopause
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Sleep diary	Sleep diary is recorded by study participants daily.	V0(screening period), V1(dsy 1), V2(week 4), V3(week 8)
Secondary	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)
Secondary	Menopause-specific Quality of Life Scale	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)
Secondary	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)
Secondary	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)

External Links

•   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
•   Guideline for the evaluation and treatment of insomnia in Chinese adults(2017)
•   The 2023 Chinese menopause symptom management and menopausal hormone therapy guidelines