Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295822
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-02-25
Brief Title:
The Effectiveness of Chinese Medicine Nuan-gong-ye on Primary Dysmenorrhea
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
The Effectiveness of Chinese Medicine Nuan-gong-ye on Primary Dysmenorrhea
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Primary dysmenorrhea is a common under-diagnosed complaint with a prevalence of about 45-95 in women of childbearing age and about 10-25 in severe cases Menstrual pain can be classified as primary or secondary Primary menstrual pain is a crampy pain in the lower abdomen without any pelvic pathology which usually occurs 6 to 12 months after the first menstruation Primary menstrual pain is usually most severe on the first day of the menstrual cycle and lasts for 8 to 72 hours The cause is still unknown but studies suggest that it may be related to increased prostaglandins which cause painful contractions of the uterus The pain is often accompanied by other menstrual discomfort symptoms including headache breast tenderness drowsiness nausea vomiting constipation or diarrhea and psychological anxiety depression or irritability In the case of secondary menstrual pain there are clear pelvic pathologies such as endometriosis uterine fibroids and pelvic inflammatory disease
Detailed Description:
In this study the ingredients of nuan-gong-ye are myrrh dragons blood yanhu tuber white mustard seed asarum root argy wormwood leaf holly oil clove oil cinnamon bark oil glycerin PEG400 while the placebo was 120 concentration of nuan-gong-ye plus glycerin and PEG400 all from the same batch A bottle of nuan-gong-ye will be taken for HPLC fingerprint to examine its components A total of 140 people will be divided randomly into two groups of which the experimental group using nuan-gong-ye and the control group using a placebo Four menstrual cycles of the clinical trial will be conducted after recruitment The first menstrual cycle will be non-interventional with subjects filling out Basic information sheet Visual Analogue Scale VAS and Short Form McGill Pain Questionnaire MPQ-SF In the second to fourth menstrual cycles two bottles of approximately 16 ml of nuan-gong-ye will be applied During these three cycles the application will begin five days before each menstrual period and end on the third day of the menstruation with the VAS McGill scale and side effects questionnaire being completed The skin should be dry before application For each application of nuan-gong-ye or placebo apply 10 circles clockwise from the navel to a circular area with a radius of 8 to 13 cm The first application will be done after waking up the second and third apply every five hours and the fourth apply at bedtime for a total of four applications a day Other relief measures such as Chinese medicine hot compresses abdominal massage acupuncture and the use of other essential oils are prohibited during the research period while painkillers are not
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None