Day and Night Hot Flash During Menopause

Menopause Clinical Trial

Official title:

The Relationship Between Day and Night Hot Flash During Menopause and Different Traditional Chinese Constitution Types in Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04878081
• Other study ID #: CMUH109-REC1-184
• Status: Not yet recruiting
• Start date: May 1, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2021
• Source: China Medical University Hospital
• Contact: Shan-Yu Su
• Phone: 886-4-22052121
• Email: shanyusu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 63
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hot Flashes
• Menopause

Intervention

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.

Locations

Country	Name	City	State
Taiwan	CMUH	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of daily hot flush symptoms	the change of daily hot flush symptoms	30 days