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A randomized controlled trial for combination of acupuncture and traditional Chinese medicine in the treatment of Migraine according to the rule of ''Xuan-Yang Jie-Yu, Tong-Luo Zhi-Tong''

Evidence-based evaluation of the combined program of acupuncture and traditional Chinese medicine of Xuanyangjieyu, Tongluozhitong

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003296
Enrollment
Unknown
Registered
2020-05-13
Start date
2020-07-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Migraine

Interventions

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Between the ages of 18 and 55 (the first migraine is less than 50), regardless of gender, and with six or more years of education 2. The patients met the diagnostic criteria for ICHD-3 migraines without aura 3. In the last three months, the number of migraine attacks per month was more than 2 times, and the number of headache days per month was less than 15 days 4. Migraines were moderate at baseline (mean VAS score 3-7) 5. Have a history of migraines for more than one year 6. Patients who were able to complete the baseline headache diary 7. The patient signed the informed consent Note: only patients who meet the above 7 criteria can be included in this study.

Exclusion criteria

Exclusion criteria: 1. Patients with other primary headache and headache with unknown diagnosis; 2. Patients with severe primary diseases such as cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system, and other organic diseases 3. Patients with a history of head trauma and mental and mental disorders who were unable to respond to the questionnaire 4. The patient that has haemorrhage tendency, allergic constitution person and skin disease 5. Pregnant women and lactating women, who have the requirement of childbirth in the past 5 months 6. Patients who cannot understand or keep a headache diary 7. The patient who has the habit of taking analgesics, alcohol and so on for a long time 8. Patients who had received acupuncture or other preventive therapy within the last 4 weeks 9. Patients who had participated in a similar study within 3 months Note: patients who meet any of the above criteria should be excluded.

Design outcomes

Secondary

MeasureTime frame
Health Economics indexes;The duration of each headache;Subject compliance analysis;VAS score of headache intensity;Treatment response rate;The percentage of patients taking acute analgesic drugs;The score of HIT-6 scale;The score of MSQ scale;

Primary

MeasureTime frame
Number of headaches in a month;

Countries

China

Contacts

Public ContactLi Bin

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University/Beijing institute of Traditional Chinese Medicine

libin@bjzhongyi.com+86 18910781852

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026