Perimenopause | Acupuncture for Relieving Perimenopausal Symptoms
Perimenopause research study
What is the primary objective of this study?
The purpose of this study is to determine whether acupuncture is effective for relieving perimenopausal symptoms.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:AcupunctureAcupuncture 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.
Drug:Climen 21 TabletsClimen Tablets are commonly used for menopausal symptoms
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
AcupunctureUsing 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 TabletsCOMPOSITION 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.
Start Date: September 2013
Completed Date: August 2015
Phase: Phase 2/Phase 3
Primary Outcome: Menopause Rating Scale
Secondary Outcome: Menopausal Specific Quality of Life Questionnaire
Study sponsors, principal investigator, and references
Principal Investigator: Ying Li, MD, PhD
Lead Sponsor: Chengdu University of Traditional Chinese Medicine
Collaborator: Chengdu First people's hospital