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