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NCT00995917 · ClinicalTrials.gov registry record · NA
A Pilot Study of Acupoint Injection for Primary Dysmenorrhea
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT00995917 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 18 participants.
The verdict
NCT00995917, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study Summary
Many women, particularly adolescent women, suffer from painful menstrual cramps, medically referred to as dysmenorrhea. Common treatments for menstrual cramps are non-steroidal anti-inflammatory drugs and oral contraceptives, but both have side effects that limit their use. Injection of vitamin K into an acupuncture point has been used as treatment for dysmenorrhea at the Obstetrics \& Gynecology Hospital in Shanghai, China since at least 1985. More research is needed on the effectiveness of this treatment and its acceptability to different women. The objective of this study is to examine the feasibility and effectiveness of acupoint injection of vitamin K1 for the treatment of severe primary dysmenorrhea in the United States. Twenty participants will be randomized to receive either 1) vitamin K1 injection into an acupuncture point at the start of their menstrual cycle followed by a saline injection in a non-acupuncture point two months later or 2) saline injection in a non-acupuncture point followed by vitamin K1 injection into an acupuncture point two months later. The primary outcome measure will be change in pain intensity measured before and after each treatment. Data on other menstrual symptoms will be collected by telephone or a web-based survey. Three additional participants will be recruited to receive vitamin K1 injection into an acupuncture point and have blood samples drawn before and after injection to determine absorption of vitamin K1. The aims of the study are to collect preliminary data on the efficacy and safety of vitamin K1 injected in an acupoint for the treatment of severe primary dysmenorrhea; assess the feasibility and acceptability of the treatment among U.S. women; and test the blood absorption of vitamin K1 following acupoint injection treatment. The investigators hypothesize that: 1. Vitamin K1 acupoint injection is a safe treatment for women with menstrual pain. 2. Vitamin K1 acupoint injection reduces menstrual pain more than placebo
Interventions
- OTHER Vitamin K acupoint injection
- OTHER Saline Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00995917
The ClinicalTrials.gov registry entry for NCT00995917 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vitamin K acupoint injection is the first listed.
NCT00995917 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00995917 about?
NCT00995917 is a clinical study titled "A Pilot Study of Acupoint Injection for Primary Dysmenorrhea". Many women, particularly adolescent women, suffer from painful menstrual cramps, medically referred to as dysmenorrhea. Common treatments for menstrual cramps are non-steroidal anti-inflammatory drugs and oral contraceptives, but both have side effects that limit their use. Injection of vitamin K in...
What is the current status of trial NCT00995917?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2009-10. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00995917?
The interventions under investigation include: Vitamin K acupoint injection (OTHER), Saline Injection (OTHER).
Who is sponsoring clinical trial NCT00995917?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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