RecruitingNot ApplicableNCT06295822

The Effectiveness of Chinese Medicine Nuan-gong-ye on Primary Dysmenorrhea


Sponsor

China Medical University Hospital

Enrollment

82 participants

Start Date

Mar 4, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 40 Years

Inclusion Criteria6

  • year-old women
  • Regular menstrual cycle of 21-35 days, with menstruation lasting 3-7 days
  • Dysmenorrhea started before the age of 20, and have menstrual pain every month
  • No organic lesions on ultrasound within one year (either abdomen or vagina)
  • VAS score above 4
  • Agree to participate in the study and sign the consent form

Exclusion Criteria8

  • Has used the same formula of Nuan-gong-ye before.
  • Allergic to Nuan-gong-ye.
  • Has abdominal wounds, infections, or skin diseases.
  • Pregnant or planning to become pregnant within the next five months.
  • Has taken traditional Chinese medicine or prescribed medication for menstrual pain by a Chinese medicine doctor in the past month.
  • Has major illnesses defined by the Taiwan National Health Insurance Administration, such as cancer, heart disease, etc.
  • Has mental illness or cognitive impairment and cannot independently fill out the questionnaire.
  • Has a history of epilepsy or pelvic disorders.

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Interventions

DRUGNuan-gong-ye

In this study, the ingredients of nuan-gong-ye are myrrh, dragon's blood, yanhu tuber, white mustard seed, asarum root, argy wormwood leaf, holly oil, clove oil, cinnamon bark oil, glycerin, PEG400.

OTHERPlacebo

The placebo was 1/20 concentration of nuan-gong-ye plus glycerin and PEG400.


Locations(1)

China Medical University Hospital

Taichung, Taiwan

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NCT06295822


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