Chinese MedicineNCT06295822
The Effectiveness of Chinese Medicine Nuan-gong-ye on Primary Dysmenorrhea
A study testing Nuan-gong-ye in people with Chinese Medicine and Primary Dysmenorrhea, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chinese Medicine, Primary Dysmenorrhea
- What is being tested?
- Nuan-gong-ye
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Mar 2024to 28 Feb 2026
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-40 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
HSUAN HSUAN WU, +886928030693, whh900710@gmail.com
About this study
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.
Read the detailed description
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, while the placebo was 1/20 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.
- Conditions
- Chinese Medicine, Primary Dysmenorrhea
- Being tested
- Nuan-gong-ye, Placebo
- Keywords
- Chinese Medicine, Nuan-gong-ye, Primary dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
The placebo was 1/20 concentration of nuan-gong-ye plus glycerin and PEG400.
| Study group | Role | What they receive |
|---|---|---|
| Nuan-gong-ye | Experimental | Not described Receives: Drug: Nuan-gong-ye |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (1)
Short Form McGill Pain Questionnaire (MPQ-SF)
Pain perception was measured by the Short Form McGill Pain Questionnaire (MPQ-SF). The scale consists of 15 items, with scores ranging from 0 to 3 to assess the intensity of each pain. 0 represents 'none,' 1 represents 'mild pain,' 2 represents 'moderate pain,' and 3 represents 'severe pain.' The VAS and McGill scales were used to assess the difference before and after each menstrual cycle.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start4 Mar 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chinese MedicineStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295822
- Sponsor's protocol ID
- CMUH112-REC2-063
- Status last verified
- Apr 2024
- First submitted
- 25 Feb 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Chinese Medicine Nuan-gong-ye on Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06295822
- Acronym / sponsor ID
- CMUH112-REC2-063
- Conditions
- Chinese Medicine, Primary Dysmenorrhea
- Keywords
- Chinese Medicine, Nuan-gong-ye, Primary dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 6 Mar 2024 (actual)
- 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.
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, dragon's blood, yanhu tuber, white mustard seed, asarum root, argy wormwood leaf, holly oil, clove oil, cinnamon bark oil, glycerin, PEG400, while the placebo was 1/20 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nuan-gong-ye | Experimental | Drug: Nuan-gong-ye |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 20-40 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
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Nuan-gong-yeIn 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. | Drug | Nuan-gong-ye |
| PlaceboThe placebo was 1/20 concentration of nuan-gong-ye plus glycerin and PEG400. | Other | Placebo |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 4 months
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.
1 secondary outcome
Short Form McGill Pain Questionnaire (MPQ-SF)
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nuan-gong-ye in people with Chinese Medicine and Primary Dysmenorrhea, run by China Medical University Hospital at 1 site in Taiwan.
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 6 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. 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 Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HSUAN HSUAN WU (+886928030693, whh900710@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2024.