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Day and Night Hot Flash During Menopause

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ClinicalTrials.gov Identifier: NCT04878081
Recruitment Status : Not yet recruiting
First Posted : May 7, 2021
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Menopause Behavioral: hot flush

Detailed Description:
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.
Study Design
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Study Type : Observational
Estimated Enrollment : 63 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Relationship Between Day and Night Hot Flash During Menopause and Different Traditional Chinese Constitution Types in Women
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2025
Groups and Cohorts
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Intervention Details:
  • Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. the change of daily hot flush symptoms [ Time Frame: 30 days ]
    the change of daily hot flush symptoms


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
menopausal women
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04878081


Contacts
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Contact: Shan-Yu Su 886-4-22052121 ext 4561 shanyusu@gmail.com

Locations
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Taiwan
CMUH
Taichung, Taiwan, 404
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Study Director: Shan-Yu Su, M.D. Ph.D. 886-4-22052121 Ext. 4561
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT04878081    
Other Study ID Numbers: CMUH109-REC1-184
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hot Flashes