Acupuncture for Relieving Perimenopausal Symptoms

Perimenopause Clinical Trial

Official title:

Acupuncture for Relieving Perimenopausal Symptoms: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933204
• Other study ID #: 2012BAI24B01
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2013
• Est. completion date: August 2015

Study information

• Verified date: February 2020
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Perimenopause

Intervention

Other:
• 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.

Drug:
• Climen 21 Tablets
Climen Tablets are commonly used for menopausal symptoms

Locations

Country	Name	City	State
China	Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan
China	First affiliated hospital of Chengdu University of TCM	Chengdu	Sichuan

Sponsors (3)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine	Chengdu First people's hospital, Chengdu PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Menopausal Specific Quality of Life Questionnaire	The Menopausal Specific Quality of Life Questionnaire (MENQOL) is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29).	asessed 0, 6, 12, 24, 36 weeks after randomization
Secondary	Average hot flash score during 24 hours		0, 12, 24, 36 weeks after randomization
Secondary	Level of Estradiol in serum		0, 12, 24 weeks after randomization
Secondary	Level of follicle stimulating hormone in serum		0, 12, 24 weeks after randomization
Secondary	Level of luteinizing hormone in serum		0, 12, 24 weeks after randomization