DysmenorrheaPhase 1NCT00104546
Vitamin K Injections for the Treatment of Painful Menstruation
A Phase 1 study testing Acupuncture point injection of vitamin K in people with Dysmenorrhea, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in China.
Trial summary
The purpose of this study is to test the feasibility and effectiveness of vitamin K injections into certain body parts for the treatment of painful menstruation. Read more about this study
- Who is it for?
- Ages 14 to 25 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Acupuncture point injection of vitamin K
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Sep 2004to Mar 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Dysmenorrhea for at least 6 months prior to study entry
- Have never been pregnant or have given birth
- Mandarin Chinese or Shanghainese speaking
- Regular menstrual cycles for at least 6 months prior to diagnosis of dysmenorrhea
- Has a working home phone or cellular phone
- Willing to disclose address
- Intends to stay in the area during the study
- Parent or guardian willing to provide informed consent, if applicable
Who cannot join
- Dysmenorrhea due to any suspected or recognized causes
- Current use of hormonal contraceptives or an intrauterine device
- History of abdominal surgery
- Other concomitant therapy for acute or chronic pain
- Anticoagulant drugs
- Vitamin K acu-injections at leg acupuncture points prior to study entry
- Intolerance to NSAIDs
- Known allergy to vitamin K
Trial locations and contacts
1 site in 1 country.
China1 site
Menstrual Disorder Clinic of the OBS/GYN Hospital of Fudan University
Shanghai
About this study
Official title: Vitamin K Injection Treatment for Primary Dysmenorrhea: A Controlled Pilot Study
The purpose of this study is to test the feasibility and effectiveness of vitamin K injections into certain body parts for the treatment of painful menstruation.
Read the detailed description
Painful menstruation, also known as dysmenorrhea, is a common problem affecting a significant percentage of women. In the United States and Europe, nonsteroidal anti-inflammatory drugs (NSAIDs) and oral contraceptives are the most commonly prescribed treatments for this condition. However, in China, oral contraceptives are not commonly prescribed for unmarried women. Acu-injection, a procedure involving the injection of vitamin K into acupuncture points, has become standard treatment for dysmenorrhea at many Chinese health care facilities. This trial will assess the willingness of young Chinese women to participate in an acu-injection trial, explore the utility of pain measurements after injection, and determine the effectiveness of the injections. This study will also help in planning larger acu-injection clinical trials.
This study will last for five menstrual cycles. Participants will be randomly assigned to one of three groups. Group 1 participants will receive a vitamin K3 injection in an acupuncture point of both legs and a saline injection in the right buttock. Group 2 participants will receive a saline injection in an acupuncture point of both legs and a saline injection in the right buttock. Group 3 participants will receive a saline injection in a pseudo-acupuncture point of both legs and a vitamin K3 injection in the right buttock. Injections will be administered one time during the first 2 days of the first menstrual cycle for participants who are experiencing menstrual pain. Participants will record their level of menstrual pain before injection and at 2, 5, 30 and 60 minutes after the injections. Participants who do not respond to or are not satisfied with the acu-injection treatment will be offered either Chinese herbal medicine or NSAIDs within 1 hour of the injection. After the injection visit, participants will be asked to complete questionnaires about any menstrual pain or side effects they may be experiencing for five subsequent menstrual cycles.
- Conditions
- Dysmenorrhea
- Being tested
- Acupuncture point injection of vitamin K
- Keywords
- Dysmenorrhea, Acupuncture, Vitamin K, Medicine, Chinese Traditional, Women, Menstruation, Pain, Menstrual, China
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture point injection of vitamin KProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of menstrual pain before and 2, 5, 30, and 60 minutes after treatment by a 10 point Visual Analog Scale (VAS)
presence and severity of recurrences of menstrual pain pre- and post-treatment and in 5 subsequent cycles after therapy
Cox retrospective symptom scale
Moos score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2005 (estimated)
- Study startSep 2004
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Fredi Kronenberg, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104546
- Sponsor's protocol ID
- R21AT001957
- Status last verified
- Jan 2008
- First submitted
- 1 Mar 2005
- Last updated
- 25 Jan 2008
- Results posted
- No
Publications
Wade C, Wang L, Zhao WJ, Cardini F, Kronenberg F, Gui SQ, Ying Z, Zhao NQ, Chao MT, Yu J. Acupuncture point injection treatment of primary dysmenorrhoea: a randomised, double blind, controlled study. BMJ Open. 2016 Jan 5;6(1):e008166. doi: 10.1136/bmjopen-2015-008166.
PubMed 26733563
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin K Injection Treatment for Primary Dysmenorrhea: A Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT00104546
- Acronym / sponsor ID
- R21AT001957
- Conditions
- Dysmenorrhea
- Keywords
- Dysmenorrhea, Acupuncture, Vitamin K, Medicine, Chinese Traditional, Women, Menstruation, Pain, Menstrual, China
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 2 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the feasibility and effectiveness of vitamin K injections into certain body parts for the treatment of painful menstruation.
Detailed description
Painful menstruation, also known as dysmenorrhea, is a common problem affecting a significant percentage of women. In the United States and Europe, nonsteroidal anti-inflammatory drugs (NSAIDs) and oral contraceptives are the most commonly prescribed treatments for this condition. However, in China, oral contraceptives are not commonly prescribed for unmarried women. Acu-injection, a procedure involving the injection of vitamin K into acupuncture points, has become standard treatment for dysmenorrhea at many Chinese health care facilities. This trial will assess the willingness of young Chinese women to participate in an acu-injection trial, explore the utility of pain measurements after injection, and determine the effectiveness of the injections. This study will also help in planning larger acu-injection clinical trials.
This study will last for five menstrual cycles. Participants will be randomly assigned to one of three groups. Group 1 participants will receive a vitamin K3 injection in an acupuncture point of both legs and a saline injection in the right buttock. Group 2 participants will receive a saline injection in an acupuncture point of both legs and a saline injection in the right buttock. Group 3 participants will receive a saline injection in a pseudo-acupuncture point of both legs and a vitamin K3 injection in the right buttock. Injections will be administered one time during the first 2 days of the first menstrual cycle for participants who are experiencing menstrual pain. Participants will record their level of menstrual pain before injection and at 2, 5, 30 and 60 minutes after the injections. Participants who do not respond to or are not satisfied with the acu-injection treatment will be offered either Chinese herbal medicine or NSAIDs within 1 hour of the injection. After the injection visit, participants will be asked to complete questionnaires about any menstrual pain or side effects they may be experiencing for five subsequent menstrual cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 14 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Dysmenorrhea for at least 6 months prior to study entry
- Have never been pregnant or have given birth
- Mandarin Chinese or Shanghainese speaking
- Regular menstrual cycles for at least 6 months prior to diagnosis of dysmenorrhea
- Has a working home phone or cellular phone
Key exclusion criteria (8 listed)
- Dysmenorrhea due to any suspected or recognized causes
- Current use of hormonal contraceptives or an intrauterine device
- History of abdominal surgery
- Other concomitant therapy for acute or chronic pain
- Anticoagulant drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture point injection of vitamin K | Procedure or surgery | – |
Primary outcome
Intensity of menstrual pain before and 2, 5, 30, and 60 minutes after treatment by a 10 point Visual Analog Scale (VAS)
presence and severity of recurrences of menstrual pain pre- and post-treatment and in 5 subsequent cycles after therapy
Cox retrospective symptom scale
Moos score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2008.
- Derived from this study: PubMed 26733563Wade C, Wang L, Zhao WJ, Cardini F, Kronenberg F, Gui SQ, Ying Z, Zhao NQ, Chao MT, Yu J. Acupuncture point injection treatment of primary dysmenorrhoea: a randomised, double blind, controlled study. BMJ Open. 2016 Jan 5;6(1):e008166. doi: 10.1136/bmjopen-2015-008166.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredi Kronenberg, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acupuncture point injection of vitamin K in people with Dysmenorrhea, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of menstrual pain before and 2, 5, 30, and 60 minutes after treatment by a 10 point Visual Analog Scale (VAS). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00104546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2008.