Status:
COMPLETED
Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborating Sponsors:
Ministry of Science and Technology of the People´s Republic of China
Conditions:
Menopausal Syndrome
Eligibility:
FEMALE
40-55 years
Phase:
NA
Brief Summary
The primary object is to evaluate the efficacy and safety of electroacupuncture for symptoms of women during menopausal transition .
Detailed Description
Menopause transition is called perimenopause in the past time. 40-80% women aged 40 to 65 have symptoms during this period. Hormone therapy is the recommended therapy for menopause and there is not en...
Eligibility Criteria
Inclusion
- Cycle irregularity (periods occur 7 days or over earlier or later ) in the past 12 months (early menopausal transition); subjects with the last menstruation at least 2 but no longer than 12 months in the past 12 months (late menopausal transition).
- Menopausal transition symptoms such as hot flushes, sweating, sleep disturbance, migraine, anxiety, vaginal dryness and sexual problems.
- 40 to 55 years old.
- Volunteer to join in the trial and sign the informed consent. Patients conformed with the 4 items at the same time will be included. -
Exclusion
- Regular cycles during the past 3 months before enrollment.
- use of estrogen, SSRIs, soybean isoflavone, progestin, vitamin E or black sesame in the past 4 weeks.
- Patients with ovarian cyst, uterine myoma (diameter≥4cm) or after hysterectomy/ ovariectomy.
- Patients with radiochemotherapy history or undergoing radiochemotherapy.
- Cryptogenic vaginal bleeding
- Coagulation disorder or use of anticoagulants like warfarin and heparin sodium.
- Existing skin diseases like eczema or psoriasis.
- Severe hepatic/renal insufficiency.
- Insufficiently controlled hypertension, diabetes or thyroid diseases.
- Existing diabetic neuropathy, malignant tumor and psychiatric disorders.
- Wish to become pregnant or is pregnant or breast-feeding.
- Regular use of sedative or anxiolytic.
- Smoking or alcohol intake.
- Subjects with mandatory indication for HT (e.g. postsurgical menopause or active osteoporosis).
- With cardiac pacemaker or artificial joint.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT01849172
Start Date
June 1 2013
End Date
December 1 2016
Last Update
April 2 2019
Active Locations (1)
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1
Guangan'men Hospital
Beijing, China, 100053