Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT06117969
Eligibility Criteria:
Inclusion Criteria:
* women aged 40-60
* natural menopause for 1-10 years
* PSQI score \>=11 points
* improved K-score\>=14 points
* able to independently sign informed consent forms
Exclusion Criteria:
* Vaginal bleeding of unknown cause
* Known or suspected breast cancer and other sex hormone dependent tumors
* Active venous or arterial thromboembolic disease within past 6 months
* Have used sex hormone or traditional Chinese medicine/botanical drugs that affect menopausal symptoms within the past month
* Have used anti anxiety, depression drugs or sedative hypnotics within the past month
* Patients with anxiety or depression above moderate level
* Severe liver or kidney dysfunction, with transaminase or creatinine level exceeding twice of the normal value
* BMI ≥ 28 kg/m2
* Allergies to research drugs
* Other situations that doctor deems unsuitable to participate in the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
60 Years
Study:
NCT06117969
Study Brief:
Protocol Section:
NCT06117969