migraine
Conditions
Interventions
Group 1:oral administration of Tianshu Capsule
Group 2:oral administration of topiramate
Group 3:oral administration of placebo
Sponsors
Neurology Department of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) complying with the criteria of the International Classification of Migraine Disorders (with aura or without aura), 3rd edition; 2) The age of the first migraine attack was = 50 years old; 3) a history of migraine for at least 12 months; 4) At least 6 attacks,during the 3 months pre-introduction period; 5) 2-4 attacks during 2 weeks introduction period 6) less than 7 Migraine days during 2 weeks preintroduction period; 7) aged 18 to 65 year; 8) Subjects were able to accurately identify migraine and understand the investigator's instructions and were able to independently complete the headache-diary record; 9) participants signed consent forms for this trial.
Exclusion criteria
Exclusion criteria: 1) The headache can't match the criteria of paroxysmal migraine; 2) Combined with other types of headache, including consequential headache patients; 3) Patients with thrombocytopenia, glaucoma, peripheral vascular disease, or Raynaud's syndrome; 4) Participate in this trial and participate in other clinical trials within the first 3 months of participation, including participation in drug therapy and alternative therapies (eg acupuncture, massage, percutaneous electrical stimulation, etc.); 5) Patients undergoing facial surgery of the sphenopalatine ganglion region due to plastic surgery, correction, treatment, or trauma; 6) Combined with liver and kidney function damage: ALT =3× ULN; AST =3× ULN 3; Cr = ULN; TBIL=2× ULN 7) Patients with other serious cardiovascular and hematopoietic diseases and hematopoietic diseases; patients with malignant tumors; 8) Patients who have recently undergone major surgery or trauma are not eligible to participate in this study 9) Patients with schizophrenia, major depression (HAMD scale >24), alcohol dependence, history of drug abuse; 10) Patients with irritable bowel syndrome and inflammatory bowel disease; 11) Pregnancy and breastfeeding women and those who have a birth plan within 3 months of the trial or after the stop of medication; 12) Allergies or encounter a wide range of drug allergies, or to study the ingredients of the medication for allergic persons; 13) Patients who have taken antibiotics within 2 weeks prior to the test, or have used drugs that affect the intestinal microflora, and within 2 weeks of the introduction period, the above drugs cannot stop users; 14) Take painkillers >10 days/month; 15) Patients taking Tianshu Capsules or other preventive treatment drugs within one month before the test; 16) Other patients who should not be involved in this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Number of headache days per month;simultaneous phenomenon;Headache Impact Test-6; | — |
Primary
| Measure | Time frame |
|---|---|
| Frequency of headache;Duration of headache;Response rates;VAS score; | — |
Countries
China
Contacts
Public ContactShengyuan Yu
Neurology Department of Chinese PLA General Hospital
Outcome results
None listed