Status:
COMPLETED
Comparison Study for Perimenopausal Syndrome With Chinese Herbal Medicine
Lead Sponsor:
Hong Kong Baptist University
Conditions:
Menopausal Syndrome
Eligibility:
FEMALE
45-55 years
Phase:
NA
Brief Summary
Background: Perimenopausal syndrome (PMS) refers to a series of symptoms caused by the dynamic fluctuations of sex hormones during menopause. Menopausal symptoms including hot flushes, vaginal dryness...
Detailed Description
Perimenopausal syndrome is also known as menopausal syndrome. Menopause Syndrome refers to women due to ovarian dysfunction or loss of estrogen causing a variety of systemic dysfunctions in the body, ...
Eligibility Criteria
Inclusion
- Chinese women aged 45-55 years
- Menstruation abnormalities (menstrual irregularity in past 12 months; or menstrual period off at least twice in past 12 months; or amenorrhea of 2 to 12 months)
- Suffering any of the following perimenopausal symptoms: vasomotor symptoms (hot flushes, sweats), psychological symptoms (insomnia, migraine, irritability), or genitourinary symptoms (vaginal dryness, dyspareunia)
- Did not use hormonal therapy at least 3 months before entry into the study
- Willing to give a written informed consent form to participate in the clinical study
Exclusion
- Bilateral ovarian resection or pelvic radiotherapy for ovarian cysts and uterine fibroids with a diameter greater than 4 cm
- Unexplained irregular vaginal bleeding
- Suffer from diabetic neuropathy or malignant tumor
- Have used sex hormones in the past 3 months, such as estrogen, progesterone, soy isoflavones etc.
- Patients who have participated in or are participating in other clinical trials in the past 3 months
- Serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system
- Take sedatives or anti-anxiety drugs regularly
- Smoking or alcohol habits
- Patients with mental illness
- Cannot cooperate with the treatment
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05266079
Start Date
March 14 2022
End Date
June 30 2023
Last Update
September 29 2023
Active Locations (1)
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1
HKFTU Workers' Medical Clinics - Hong Kong Baptist University Chinese Medicine Clinic cum Training and Research Centre (North District)
Hong Kong, Hong Kong