Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104546
Status:
COMPLETED
Last Update Posted:
2008-01-25
First Post:
2005-03-01
Brief Title:
Vitamin K Injections for the Treatment of Painful Menstruation
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Vitamin K Injection Treatment for Primary Dysmenorrhea A Controlled Pilot Study
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None