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

Evaluation of Traditional Chinese Medicine of Xuanyang Jieyu, Tongluo Zhitong: a Randomized Controlled Trial.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003340
Enrollment
Unknown
Registered
2020-05-25
Start date
2020-06-01
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

The Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Between the ages of 18 and 55 years (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

Primary

MeasureTime frame
Frequency of migraine attacks;

Secondary

MeasureTime frame
Migraine Specific Quality of Life Question, MSQ;Calcitonin Gene related Peptide, CGRP;Intensity of migraine;Treatment response rate;Headache impact scale (HIT-6);Headache duration (hours);Patient treatment satisfaction evaluation;TCM syndrome assessment scale;Days of migraine attack;Percentage of patients taking acute analgesic;

Countries

China

Contacts

Public ContactZhao Yonglie

The Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine

yongy3@126.com+86 13641086409

Outcome results

None listed

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