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the Effects of Different Therapy Regimens on Menopausal Sleep Disorders

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Not yet enrolling
Phase 4

Conditions

Menopause
Sleep Disorder

Treatments

Drug: Tibolone plus Xiangshao granules
Drug: Xiangshao granules
Drug: Tibolone

Study type

Interventional

Funder types

Other

Identifiers

NCT06117969
menopausal sleep disorders

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

Female

Ages

40 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 3 patient groups

Tibolone
Experimental group
Description:
take Tibolone 1.25mg/day orally for 8 weeks
Treatment:
Drug: Tibolone
Xiangshao granules
Experimental group
Description:
take Xiangshao granules orally 3 times a day, 4g each time
Treatment:
Drug: Xiangshao granules
Tibolone plus Xiangshao granules
Experimental group
Description:
take Tibolone 1.25mg/day and Xiangshao granules 3 times a day, 4g each time orally for 8 weeks
Treatment:
Drug: Tibolone plus Xiangshao granules

Trial documents
1

Trial contacts and locations

0

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Central trial contact

Lingjin Yang; Rong Chen, Professor

Data sourced from clinicaltrials.gov

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