Dysmenorrhea Clinical Trial
Official title:
Randomized Controlled Trial of Acupuncture on the Effect of Quality of Life and Clinical Efficacy for Dysmenorrhea Patients.
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital Yun-Lin Branch | Yun-Lin |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
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
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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