NCT06295822

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

March 4, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

1.5 years

First QC Date

February 25, 2024

Last Update Submit

April 9, 2024

Conditions

Chinese MedicinePrimary Dysmenorrhea

Keywords

Chinese MedicineNuan-gong-yePrimary dysmenorrhea

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS)

    The intensity of menstrual pain was measured by the Visual Analogue Scale (VAS). The VAS scale is a continuous horizontal line ten centimeters in length. The left end of the line, marked as 0, represents 'no pain,' while the right end, marked as 10, represents 'the most intense pain'. The VAS and McGill scales were used to assess the difference before and after each menstrual cycle.

    4 months

Secondary Outcomes (1)

  • Short Form McGill Pain Questionnaire (MPQ-SF)

    4 months

Study Arms (2)

Nuan-gong-ye

EXPERIMENTAL
Drug: Nuan-gong-ye

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Nuan-gong-yeDRUG

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.

Nuan-gong-ye
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

Central Study Contacts

HSUAN HSUAN WU

CONTACT

+886928030693whh900710@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2024

First Posted

March 6, 2024

Study Start

March 4, 2024

Primary Completion

August 31, 2025

Study Completion

February 28, 2026

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)