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The parallel randomized, double-blind, placebo controlled, multicenter clinical trial of Toutongning capsule in the treatment of migraine headache.

The parallel randomized, double-blind, placebo controlled, multicenter clinical trial of Toutongning capsule in the treatment of migraine headache

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15007058
Enrollment
Unknown
Registered
2015-09-11
Start date
2014-06-10
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

migraine

Interventions

Test :Toutongning capsule
Control :Toutongning capsule simulation agent

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Up to the Primary diagnosis of migraine ICHD - III standard; (2) Aged 18 to 65 years, Male or female; (3) The on age 50 or less for the first time; (4) A course of 1 year or more; (5) Migraine attacks 2 ~ 8 times Every 4 weeks , less than 15 days per month, twice migraine clearance should be at least 48 hours, didnt taking a drug to prevent migraine attacks temly; (6) Participants can accurately identify a migraine understanding the researchers instructions, can independently accomplish a headache diary; (7) Signed ICF voluntarily.

Exclusion criteria

Exclusion criteria: (1) Taking analgesic more than 10 days/month; (2) Merger control hypertension patients; (3) Nearly six months had severe infections; With severe diseases of the cardiovascular tem (severe heart failure, atrial fibrillation, cardiovascular interventional surgery) cerebrovascular disease (stroke, vascular malformations), central nervous tem infection, intracranial space-occupying lesions, or diseases such as brain injury severe primary diseases such as liver kidney hematopoietic tem; (4) Migraine is excessive drug use, other special type of migraine headache (5) Merger of cervical spondylosis ear source sex, nose source sex, tooth source sex secondary headaches (6) A history of trigeminal nerve autonomy headache (7) Combine the alcohol or other drug abusers; (8) Thrombocytopenia, glaucoma, peripheral vascular disease or raynauds syndrome; (9) Patients with psychosis, depression or anxiety; (10) In to participate in other clinical trials during this test accept other physical (including acupuncture moxibustion, masge, percutaneous nerve electrical stimulation, etc.) or drug therapy; (11) Because of cosmetic surgery, orthodontic, treatment or trauma of butterfly palatal bone ganglion area facial surgery; (12) To study drugs analgesic drugs (such as aspirin, ibuprofen, etc.) allergies; (13) The subjects compliance is bad; (14) Participated in other clinical subjects within three months; (15) Pregnant women nursing mothers.

Design outcomes

Primary

MeasureTime frame
Bain CT;vital signs;routine blood;Urinalysis;liver function;renal function;urine pregnant test;adverse event;electrocardiography;

Countries

China

Contacts

Public ContactShengyuan Yu
yusy1963@126.com+86 13501171068

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026