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Completed

NCT Number: NCT01933204

Acupuncture for Relieving Perimenopausal Symptoms

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

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Key information

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China

Loading trial locations.

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Other

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.

Climen 21 Tablets

Drug

Climen Tablets are commonly used for menopausal symptoms

Other names: Climen Tablets

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. Average hot flash score during 24 hours

    Time frame: 0, 12, 24, 36 weeks after randomization

  3. Level of Estradiol in serum

    Time frame: 0, 12, 24 weeks after randomization

  4. Level of follicle stimulating hormone in serum

    Time frame: 0, 12, 24 weeks after randomization

  5. Level of luteinizing hormone in serum

    Time frame: 0, 12, 24 weeks after randomization

Sponsors and collaborators

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Other

Collaborators

  • Chengdu First People's Hospital
  • Chengdu PLA General Hospital

Registry information

Official study title

Acupuncture for Relieving Perimenopausal Symptoms: a Randomised Controlled Trial

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 2, 2013
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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