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Clinical efficacy study of sequential acupuncture therapy for treating menstrual headaches

Clinical efficacy study of sequential acupuncture therapy for treating menstrual headaches

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002153
Enrollment
Unknown
Registered
2025-11-08
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

menstrual headaches

Interventions

Experimental Group:Basic intervention+sequential acupuncture treatment
Control Group:Basic intervention+Ibuprofen sustained-release capsules

Sponsors

Chengdu Pidu District Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Western Medicine Diagnostic Criteria 1). Diagnostic Criteria for Simple Menstrual Migraine (Appendix A1.1.1 of ICHD-3): A. Meets the diagnostic criteria for 1.1 Uniphasic Migraine without Aura. B. Headache attacks occur on the 1st ± 2 days of the menstrual cycle (i.e., from the 2nd day before menstruation to the 3rd day after menstruation). C. In at least three consecutive menstrual cycles, headache attacks occur only within the time window described in B, and there are no attacks in other cycles. D. Cannot be better explained by other diagnoses in ICHD-3. 2). Menstrual-related Migraine (Appendix A1.2.1 of ICHD-3): A. Meets the diagnostic criteria for 1.1 Uniphasic Migraine without Aura. B. Headache attacks occur on the 1st ± 2 days of the menstrual cycle (i.e., from the 2nd day before menstruation to the 3rd day after menstruation). C. In at least three consecutive menstrual cycles, headache attacks occur more frequently within the time window described in B, but there are also attacks in other cycles. D. Cannot be better explained by other diagnoses in ICHD-3. Inclusion criteria: (1) Meet the above-mentioned Western medical diagnostic criteria; (2) Age 18-45 years old, normal menstrual cycle of 28 ± 7 days, and menstrual duration of 3 to 7 days; (3) Baseline period (2 menstrual cycles during the screening period) headache severity VAS score = 4 points, monthly headache days = 2 days and = 14 days; (4) Complete a headache diary during the screening period (covering at least one complete menstrual cycle), and can prove good compliance of the patient; (5) Voluntary and willing to accept and sign the informed consent form; Note: Only those subjects who meet all 5 of the above criteria can be included in this study.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Main diagnosis is other primary or secondary headache disorders (such as tension-type headache, cluster headache, medication-overuse headache). 2. Complicated with severe or unstable cardiovascular, cerebrovascular, liver, kidney, hematological diseases, or malignant tumors. 3. Confirmed with severe mental disorders such as major depression, anxiety disorder, bipolar disorder, etc. 4. Pregnant, breastfeeding, or planning to get pregnant within 6 months. 5. Have used hormonal contraceptives or other hormone treatments that affect the menstrual cycle in the past 3 months; have taken regular painkillers, triptans, ergotamine-type acute treatment for migraine for =10 days per month in the past 3 months; have received preventive drugs for migraine, acupuncture or other systemic non-drug treatments in the past 1 month. 6. Have coagulation dysfunction, severe osteoporosis, or skin infection/brokenness at the acupuncture site; are allergic to acupuncture, moxibustion therapy or have a history of severe adverse reactions. 7. Are participating in other interventional clinical trials. 8. Are allergic to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs); have a history of active gastrointestinal ulcers, gastrointestinal bleeding, or severe liver and kidney dysfunction. 9. The investigator determines that there are other conditions that make participation in the trial inappropriate or significant safety risks. Note: All subjects meeting any of the above 9 criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
pain intensity;

Secondary

MeasureTime frame
Monthly Headache Frequency;Duration of headache;Headache and associated symptoms;

Countries

China

Contacts

Public ContactXingping Xiao

Chengdu Pidu District Traditional Chinese Medicine Hospital

990359068@qq.com18708112858

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026