Acupuncture for Relieving Perimenopausal Symptoms

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Chengdu University of Traditional Chinese Medicine
Sponsor:
Collaborators:
Chengdu First people's hospital
Chengdu PLA General Hospital
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01933204
First received: August 9, 2013
Last updated: September 2, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Perimenopause
Other: Acupuncture
Drug: Climen 21 Tablets
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture for Relieving Perimenopausal Symptoms: a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Menopause Rating Scale [ Time Frame: 12 weeks after randomization ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Menopausal Specific Quality of Life Questionnaire [ Time Frame: asessed 0, 6, 12, 24, 36 weeks after randomization ] [ Designated as safety issue: No ]
    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).

  • Average hot flash score during 24 hours [ Time Frame: 0, 12, 24, 36 weeks after randomization ] [ Designated as safety issue: No ]
  • Level of Estradiol in serum [ Time Frame: 0, 12, 24 weeks after randomization ] [ Designated as safety issue: No ]
  • Level of follicle stimulating hormone in serum [ Time Frame: 0, 12, 24 weeks after randomization ] [ Designated as safety issue: No ]
  • Level of luteinizing hormone in serum [ Time Frame: 0, 12, 24 weeks after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: September 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Active Comparator: 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.
Drug: Climen 21 Tablets
Climen Tablets are commonly used for menopausal symptoms
Other Name: Climen Tablets

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
  Eligibility

Ages Eligible for Study:   40 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933204

Contacts
Contact: Erqi Qin, Master 028-66875871 qinerqi@foxmail.com

Locations
China, Sichuan
Chengdu University of Traditional Chinese Medicine Not yet recruiting
Chengdu, Sichuan, China, 610075
Contact: Erqi Qin, Master    028-66875871    qinerqi@foxmail.com   
Sub-Investigator: Hui Zheng, MD, PhD         
First affiliated hospital of Chengdu University of TCM Recruiting
Chengdu, Sichuan, China, 610075
Contact: Er-qi Qin, MD    028-66875871    qinerqi@foxmail.com   
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Chengdu First people's hospital
Chengdu PLA General Hospital
Investigators
Principal Investigator: Ying Li, MD, PhD Chengdu University of Traditional Chinese Medicine
  More Information

No publications provided by Chengdu University of Traditional Chinese Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01933204     History of Changes
Other Study ID Numbers: 2012BAI24B01
Study First Received: August 9, 2013
Last Updated: September 2, 2013
Health Authority: China: Ministry of Science and Technology

Keywords provided by Chengdu University of Traditional Chinese Medicine:
perimenopause
hot flash
palpitation

ClinicalTrials.gov processed this record on August 18, 2014