NCT04878081

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

May 4, 2021

Last Update Submit

May 6, 2021

Conditions

Menopause

Outcome Measures

Primary Outcomes (1)

  • the change of daily hot flush symptoms

    the change of daily hot flush symptoms

    30 days

Interventions

hot flushBEHAVIORAL

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.

Eligibility Criteria

Age40 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

menopausal women

You may qualify if:

  • not accept Chinese medicine therapy for last 3 months
  • 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

You may not qualify if:

  • any types of Systemic disease
  • any chronic disease under medicine control
  • any mental disorder
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMUH

Taichung, 404, Taiwan

Location

Study Officials

  • Shan-Yu Su, M.D. Ph.D.

    886-4-22052121 Ext. 4561

    STUDY DIRECTOR

Central Study Contacts

Shan-Yu Su

CONTACT

886-4-22052121shanyusu@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 7, 2021

Study Start

May 1, 2021

Primary Completion

May 1, 2023

Study Completion

May 1, 2025

Last Updated

May 7, 2021

Record last verified: 2021-05

Locations

TW(1)