MenopauseNCT04878081
Day and Night Hot Flash During Menopause
An observational study of Menopause, run by China Medical University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 40 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- hot flush
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 63 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2021to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: menopausal women
Who may be able to join
- 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
Who cannot join
- any types of Systemic disease
- any chronic disease under medicine control
- any mental disorder
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Day and Night Hot Flash During Menopause and Different Traditional Chinese Constitution Types in 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.
Read the 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.
- Conditions
- Menopause
- Being tested
- hot flush
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hot flushBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of daily hot flush symptoms
the change of daily hot flush symptoms
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 May 2021 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shan-Yu Su, M.D. Ph.D., Study director, 886-4-22052121 Ext. 4561
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878081
- Sponsor's protocol ID
- CMUH109-REC1-184
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Day and Night Hot Flash During Menopause and Different Traditional Chinese Constitution Types in Women
- ClinicalTrials.gov ID
- NCT04878081
- Acronym / sponsor ID
- CMUH109-REC1-184
- Conditions
- Menopause
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- menopausal women
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- any types of Systemic disease
- any chronic disease under medicine control
- any mental disorder
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hot flushHot 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. | Behavioural | – |
Primary outcome
the change of daily hot flush symptoms
Time frame: 30 days
the change of daily hot flush symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shan-Yu Su, M.D. Ph.D. study director
886-4-22052121 Ext. 4561
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shan-Yu Su (886-4-22052121 ext. 4561, shanyusu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of daily hot flush symptoms (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021; AzTrials last refreshed its copy on 30 Oct 2026.