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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00995917 |
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Date of registration:
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14/10/2009 |
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Primary sponsor: |
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Public title:
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A Pilot Study of Acupoint Injection for Primary Dysmenorrhea
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Scientific title:
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A Randomized, Crossover, Pilot Trial of the Feasibility and Safety of Acupoint Injection of Vitamin K for Treatment of Primary Dysmenorrhea |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00995917 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Maria Chao, Dr PH, MPA |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Young women age 18-25
- Severe primary dysmenorrhea (defined as severe, recurrent painful periods for 6
months or more, that are not due to any other diagnosis, and that have not been
relieved, or have been only partially relieved by any other treatment)
- Nulliparous
- English speaking
- No acute or chronic conditions diagnosed or suspected
- Not on hormonal contraceptives
- Regular menstrual cycles for at least 6 months
- Has a working phone or pager
Exclusion Criteria:
- Use of hormonal contraceptives, or intra-uterine device
- Pregnancy
- Dysmenorrhea due to any other suspected or recognized causes
- History of abdominal surgery
- Participation in other concomitant therapy for acute or chronic pain
- Current treatment with anti-coagulant drugs for any reason
- Previous treatment with vitamin K acupoint injection
- Plans to be out of area during next 5 months
- Under age 18
- Known allergy to Vitamin K.
Age minimum:
18 Years
Age maximum:
25 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Dysmenorrhea
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Pain, Menstrual
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Intervention(s)
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Other: Saline Injection
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Other: Vitamin K acupoint injection
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Primary Outcome(s)
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self-reported pain
[Time Frame: 3-5 months]
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Secondary Outcome(s)
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activity restriction
[Time Frame: 3-5 months]
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Cox retrospective symptom scale
[Time Frame: 3-5 months]
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medications used during menstrual cycle
[Time Frame: 3-5 months]
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vitamin K content in blood
[Time Frame: 1-2 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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