Trial record 2 of 20 for:    Open Studies | "Premenopause"

Acupuncture for Relieving Perimenopausal Symptoms

This study is currently recruiting participants.
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
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

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 April 17, 2014