Acupuncture for Relieving Perimenopausal Symptoms

NCT ID: NCT01933204

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-08-31

Brief Summary

The purpose of this study is to determine whether acupuncture is effective for relieving perimenopausal symptoms.

Detailed Description

• A randomised controlled trial with superiority design
• A total of 220 participants will be included in 3 centers
• 2 arms: acupuncture group and Climen® group

Conditions

Perimenopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acupuncture

Using basic points combined with additional points. Basic points are fixed, while additional points will be selected from a list of points categorized by syndrome differentiation.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

Acupuncture is a collection of procedures involving penetration of the skin with needles to stimulate certain points on the body. In its classical form it is a characteristic component of traditional Chinese medicine (TCM), a form of alternative medicine, and one of the oldest healing practices in the world.

Climen 21 Tablets

COMPOSITION 11 white tablets each containing estradiol-17-valerate 2 mg, plus 10 pink tablets each containing estradiol-17-valerate 2 mg and cyproterone acetate 1 mg.

Group Type: ACTIVE_COMPARATOR

Climen 21 Tablets

Intervention Type: DRUG

Climen Tablets are commonly used for menopausal symptoms

Interventions

Acupuncture

Acupuncture is a collection of procedures involving penetration of the skin with needles to stimulate certain points on the body. In its classical form it is a characteristic component of traditional Chinese medicine (TCM), a form of alternative medicine, and one of the oldest healing practices in the world.

Intervention Type: OTHER

Climen 21 Tablets

Climen Tablets are commonly used for menopausal symptoms

Intervention Type: DRUG

Other Intervention Names

Climen Tablets

Eligibility Criteria

Inclusion Criteria

• Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days.
• Reported relative perimenopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
• Age 40-50 years.
• Not accompanied with conditions that are needed for hormone therapy, e.g., menopause after surgery, active osteoporosis.
• Willing to participate and signing the inform consent.

Exclusion Criteria

• Had a regular menopausal cycle 3 months before this trial.
• Taking estrogen, selective serotonin reuptake inhibitor(SSRI), soy isoflavone, progesterone, Vitamin E or black cohosh in the 4 weeks before inclusion.
• receiving chemoradiotherapy.
• Agnogenic vaginal bleeding.
• Coagulation defeats, or taking anticoagulant drugs, such as warfarin, heparin, etc.
• Dermal diseases, e.g., eczema, psoriasis.
• Liver or kidney failure.
• Uncontrollable hypertension, diabetes, or thyroid diseases.
• With diabetic neuropathy, malignant cancer and mental diseases (including depression).
• Intend to gestation, in gestation period or lactation period.
• Using sedative or antianxiety drugs.
• With smoking or intemperance problems.
• Using cardiac pacemaker, or joint prosthesis.
• Low compliance.
• Benign tumor in breast.
• Family history of breast cancer.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu First People's Hospital

OTHER

Sponsor Role: collaborator

Chengdu PLA General Hospital

OTHER

Sponsor Role: collaborator

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ying Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chengdu University of Traditional Chinese Medicine

Locations

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

First affiliated hospital of Chengdu University of TCM

Chengdu, Sichuan, China

Countries

China

References

Li Y, Zheng H, Zheng Q, Zhao L, Qin E, Wang Y, Zeng Q, Zheng H, Zhao Y, Sun W, Zhang X, Liu Z, Liu B. Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial. Trials. 2014 May 30;15:198. doi: 10.1186/1745-6215-15-198.

Reference Type: DERIVED

PMID: 24886348 (View on PubMed)

Other Identifiers

2012BAI24B01

Identifier Type: -

Identifier Source: org_study_id