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NCT Number: NCT01116453

Randomized Controlled Trial of Acupuncture for Dysmenorrhea

Since there is unsatisfactory effect by currently pharmacologic therapies and preventive strategies for dysmenorrhea, this study is designed to evaluate the efficacy and quality of life of acupuncture for patients with dysmenorrhea based on the theory of traditional Chinese Medicine.

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Key information

Age range

13 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

National Taiwan University Hospital Yun-Lin Branch

Douliu, 640, Taiwan

About this study

There were abundant clinical experiences and medical records for dysmenorrhea in traditional Chinese medicine. So we follow the worldly trend to do the research of integrative Chinese medicine and western medicine since WHO launched the first global strategy on traditional and complementary/alternative medicine (TM/CAM) to assist countries to create a stronger evidence base on the safety, efficacy and quality of the TM/CAM products and practices.

The purpose of our study is to create the evidence of effect on dysmenorrhea by acupuncture. The study will be performed under randomized, open, controlled design. The effect of acupuncture and control group will be compared including the following outcomes: pain score (Visual Analogue Scale), quality of life (SF-36, Taiwan version), overall improvement in dysmenorrhea, adverse effects from treatment, requirements for additional medication, restriction of daily life activities, absence from work or school.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • non-pregnant women who are at least 13 years old
  • the one who meet any one of the following two criteria: 1.suffering from dysmenorrhea in recent 3 menstrual periods; 2.dysmenorrhea with poor response to non-steroid anti-inflammation drugs

Exclusion criteria

  • intrauterine device-related dysmenorrhea
  • history of alcohol or drug abuser
  • women who are pregnant, as determined by a urine pregnancy test
  • history of adverse reaction to acupuncture
  • received herb or acupuncture therapy within one month prior to enrollment
  • poor compliance to investigator's advice

Treatment and study plan

Acupuncture

Procedure

acupuncture on the acupoints of ST44 and ST43 of bilateral feet for 2 months, then followed-up for another 2months

Other names: body acupuncture

usual care

Procedure

usual care with medication and behavior therapy for 2 months, followed by acupuncture for additional 2 months

Other names: delayed acupuncture

Primary outcomes

  1. visual analogue scale of pain

    Time frame: every 2 months

Secondary outcomes

  1. score of questionnaire of quality of life (SF-36)

    Time frame: every 2 months

  2. amount of additional medication

    Time frame: every 2 months

  3. degree of restriction of daily life activities

    Time frame: every 2 months

  4. degree of absence from work or school

    Time frame: every 2 months

  5. overall improvement in dysmenorrhea

    Time frame: end of acupuncture treatment

  6. safety evaluation (adverse events)

    Time frame: every week

  7. score of questionnaire of dysmenorrhea-related symptoms

    Time frame: every 2 months

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Randomized Controlled Trial of Acupuncture on the Effect of Quality of Life and Clinical Efficacy for Dysmenorrhea Patients.

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 5, 2010
Registry last updated
Mar 7, 2013

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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