Day and Night Hot Flash During Menopause

NCT ID: NCT04878081

Last Updated: 2021-05-07

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2025-05-01

Brief Summary

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We use Hot Flash Diaries to record the change of daily hot flush symptoms, The Hot Flash Related Daily Interference Scale to record how much did hot flush effect daily life, the Kupperman menopausal index to evaluate the severity of menopausal symptoms, the Pittsburgh Sleep Quality Index to evaluate sleep disorder, wireless temperature monitor to record hot flush and body temperature during sleeping, and classify patients' traditional Chinese constitution by using Physical classification and judgment self-test table. With these evaluations, we can take apart of different syndromes with different symptom of menopause, thus to confirm the specificity and the severity of menopausal hot flush, and give patients correct treatment.

Detailed Description

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Menopause syndrome or Climacteric syndrome is defined as decreasing function of ovarian follicles during menopause. This situation leads to the decreased concentration of estrogen, and causes a series of physical and psychological symptoms, with main symptoms of hot flush, night sweats, dizziness or headache, limbs soreness, insomnia, anxiety and depression. Approximately 40-60 % of menopausal women have the problem of menopausal symptoms, these symptoms severely affect the life quality of post-menopausal women. We use Hot Flash Diaries to record the change of daily hot flush symptoms, The Hot Flash Related Daily Interference Scale to record how much did hot flush effect daily life, the Kupperman menopausal index to evaluate the severity of menopausal symptoms, the Pittsburgh Sleep Quality Index to evaluate sleep disorder, wireless temperature monitor to record hot flush and body temperature during sleeping, and classify patients' traditional Chinese constitution by using Physical classification and judgment self-test table. With these evaluations, we can take apart of different syndromes with different symptom of menopause, thus to confirm the specificity and the severity of menopausal hot flush, and give patients correct treatment.

Conditions

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Menopause

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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hot flush

Hot Flash Diaries to record the change of daily hot flush symptoms for 30 days. The Hot Flash Related Daily Interference Scale to record how much did hot flush effect daily life.

The Kupperman menopausal index to evaluate the severity of menopausal symptoms. The Pittsburgh Sleep Quality Index to evaluate sleep disorder. Wireless temperature monitor to record hot flush and body temperature during sleeping.

Classify patients' traditional Chinese constitution by using Physical classification and judgment self-test table.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* not accept Chinese medicine therapy for last 3 months
* 40-55 years old female
* prolonged menstruation with hot flush, night sweats or insomnia
* regular night sleep habit
* not take oral contraceptive pill for last 6 months
* no smoking, alcohol, drug abused

Exclusion Criteria

* any types of Systemic disease
* any chronic disease under medicine control
* any mental disorder
* pregnant women
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shan-Yu Su, M.D. Ph.D.

Role: STUDY_DIRECTOR

886-4-22052121 Ext. 4561

Locations

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CMUH

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Shan-Yu Su

Role: CONTACT

886-4-22052121 ext. 4561

Other Identifiers

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CMUH109-REC1-184

Identifier Type: -

Identifier Source: org_study_id

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