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Acupuncture for Relieving Perimenopausal Symptoms

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ClinicalTrials.gov Identifier: NCT01933204
Recruitment Status : Unknown
Verified August 2013 by Chengdu University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : September 2, 2013
Last Update Posted : September 4, 2013
Sponsor:
Collaborators:
Chengdu First people's hospital
Chengdu PLA General Hospital
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine

August 9, 2013
September 2, 2013
September 4, 2013
September 2013
August 2015   (Final data collection date for primary outcome measure)
Menopause Rating Scale [ Time Frame: 12 weeks after randomization ]
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.
Same as current
Complete list of historical versions of study NCT01933204 on ClinicalTrials.gov Archive Site
  • Menopausal Specific Quality of Life Questionnaire [ Time Frame: asessed 0, 6, 12, 24, 36 weeks after randomization ]
    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 ]
  • Level of Estradiol in serum [ Time Frame: 0, 12, 24 weeks after randomization ]
  • Level of follicle stimulating hormone in serum [ Time Frame: 0, 12, 24 weeks after randomization ]
  • Level of luteinizing hormone in serum [ Time Frame: 0, 12, 24 weeks after randomization ]
Same as current
Not Provided
Not Provided
 
Acupuncture for Relieving Perimenopausal Symptoms
Acupuncture for Relieving Perimenopausal Symptoms: a Randomised Controlled Trial
The purpose of this study is to determine whether acupuncture is effective for relieving perimenopausal symptoms.
  • 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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Perimenopause
  • 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
    Other Name: Climen Tablets
  • 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.
    Intervention: Other: Acupuncture
  • 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.
    Intervention: Drug: Climen 21 Tablets
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
220
Same as current
August 2015
August 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01933204
2012BAI24B01
Yes
Not Provided
Not Provided
Chengdu University of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine
  • Chengdu First people's hospital
  • Chengdu PLA General Hospital
Principal Investigator: Ying Li, MD, PhD Chengdu University of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP