Acupuncture for Relieving Perimenopausal Symptoms
1 other identifier
interventional
220
1 country
2
Brief Summary
The purpose of this study is to determine whether acupuncture is effective for relieving perimenopausal symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedFirst Posted
Study publicly available on registry
September 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFebruary 17, 2020
February 1, 2020
1.9 years
August 9, 2013
February 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Menopause Rating Scale
The scale was developed and validated over the years from a research network of many institutions such as Organon Germany, Infratest Munich, Universities of Muenster and Berlin,the Berlin Center for Epidemiology and Health Research, etc. It is a scale consisted of 11 items, ranging from no symptoms to very severe symptoms.
12 weeks after randomization
Secondary Outcomes (5)
Menopausal Specific Quality of Life Questionnaire
asessed 0, 6, 12, 24, 36 weeks after randomization
Average hot flash score during 24 hours
0, 12, 24, 36 weeks after randomization
Level of Estradiol in serum
0, 12, 24 weeks after randomization
Level of follicle stimulating hormone in serum
0, 12, 24 weeks after randomization
Level of luteinizing hormone in serum
0, 12, 24 weeks after randomization
Study Arms (2)
Acupuncture
EXPERIMENTALUsing 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.
Climen 21 Tablets
ACTIVE COMPARATORCOMPOSITION 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.
Interventions
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 Tablets are commonly used for menopausal symptoms
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Had a regular menopausal cycle 3 months before this trial.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chengdu University of Traditional Chinese Medicinelead
- Chengdu First People's Hospitalcollaborator
- Chengdu PLA General Hospitalcollaborator
Study Sites (2)
Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610075, China
First affiliated hospital of Chengdu University of TCM
Chengdu, Sichuan, 610075, China
Related Publications (1)
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.
PMID: 24886348DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Li, MD, PhD
Chengdu University of Traditional Chinese Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2013
First Posted
September 2, 2013
Study Start
September 1, 2013
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
February 17, 2020
Record last verified: 2020-02