Clinical trial NCT04878081: Day and Night Hot Flash During Menopause
Official title: The Relationship Between Day and Night Hot Flash During Menopause and Different Traditional Chinese Constitution Types in Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Menopause
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 63
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: menopausal women

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.

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.

Eligibility 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

Primary outcomes:
measure: the change of daily hot flush symptoms
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: CMUH
Study officials:
affiliation: 886-4-22052121 Ext. 4561
name: Shan-Yu Su, M.D. Ph.D.
role: STUDY_DIRECTOR
References: