migraine
Conditions
Interventions
TTNC group:3 capsules of TTNC orally three times each day for 12 weeks
Placebo group:3 capsules of placebo orally three times each day for 12 weeks
Sponsors
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1)aged from 18 to 60 years old, unlimited on men and women;(2)diagnosis meets ICHD-3 diagnostic criteria for migraine (migraine without aura); (3)TCM diagnosed as headache disease, and differentiation as blood stasis blockade; (4)The duration of migraine =1 year and the frequency of headache attacks per month =2 in the past 3 months (the interval between the two attacks should be more than 48 hours), 3 points = pain degree score =8 points (the score of the most severe headache attack in the past 3 months), the age of the first attack of migraine =50 years old, and the frequency of headache days < 15 days per month; (5) Patients must read and understand Chinese language, adhere to the study protocol, and must provide written informed consent.
Exclusion criteria
Exclusion criteria: Major exclusion criteria included: (1) Patients with other primary headaches and other specific types of migraine, such as cluster headache, tension-type headache, etc; (2) Secondary headache caused by severe organic cranial lesions, with headache-related lesions detected by cranial CT or MRI; (3) Migraine patients who have a chronic analgesic habit, require pain medication for >10 days per month for headache attacks or have received acupuncture treatment or/and have taken prophylactic medication for migraine within 4 weeks prior to screening; (4) The patients were complicated with severe primary diseases of cardiovascular, cerebrovascular, liver, kidney, hematopoietic system and other organic lesions; (5) Patients with malignant tumor or history of malignant tumor;(6)Patients with bleeding tendency and allergic constitution;(7)pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the frequency of headache attacks during 12 weeks of TTNC treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM score;TCM Efficacy;MSQ score;VAS score;Days of headache attack;aspartate aminotransferase (AST);Total bilirubin;Direct bilirubin;Urea nitrogen;Creatinine;Alanine aminotransferase;electrocardiogram (ECG);Routine blood test;Routine urine; | — |
Countries
China
Contacts
Public ContactNianping Huang
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
Outcome results
None listed