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''

Phase 1

• Conditions: Migraine

• Registration Number: ITMCTR2000003296
• Lead Sponsor: Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of headaches in a month;

Secondary Outcome Measures

Name	Time	Method
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;