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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01116453
Other study ID # 201002022R
Secondary ID
Status Completed
Phase Phase 3
First received May 3, 2010
Last updated March 5, 2013
Start date May 2010
Est. completion date November 2012

Study information

Verified date February 2013
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date November 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Female
Age group 13 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
acupuncture
acupuncture on the acupoints of ST44 and ST43 of bilateral feet for 2 months, then followed-up for another 2months
usual care
usual care with medication and behavior therapy for 2 months, followed by acupuncture for additional 2 months

Locations

Country Name City State
Taiwan National Taiwan University Hospital Yun-Lin Branch Yun-Lin

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Witt CM, Reinhold T, Brinkhaus B, Roll S, Jena S, Willich SN. Acupuncture in patients with dysmenorrhea: a randomized study on clinical effectiveness and cost-effectiveness in usual care. Am J Obstet Gynecol. 2008 Feb;198(2):166.e1-8. doi: 10.1016/j.ajog.2007.07.041. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary visual analogue scale of pain every 2 months No
Secondary score of questionnaire of quality of life (SF-36) every 2 months No
Secondary amount of additional medication every 2 months No
Secondary degree of restriction of daily life activities every 2 months No
Secondary degree of absence from work or school every 2 months No
Secondary overall improvement in dysmenorrhea end of acupuncture treatment No
Secondary safety evaluation (adverse events) every week Yes
Secondary score of questionnaire of dysmenorrhea-related symptoms every 2 months No
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