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Dingluo nasal drops for acute migraine attacks in adults:a randomized controlled trial

Therapeutic effect of Dingluo nasal drops for acute migraine attacks

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072165
Enrollment
Unknown
Registered
2023-06-05
Start date
2023-03-09
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Migraine

Interventions

Experimental group 1:High dose Dingluo nasal drops
Experimental group 2:Low dose Dingluo nasal drops
Control group:placebo

Sponsors

Dongzhimen Hosptial, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ? Patients aged 18-65 years old (including 18 and 65 years old), whose age of first onset was less than 50 years old, and whose history of migraine =1 year; ? In line with the Western diagnostic criteria for migraine, nearly 1-month attacks 2-8 times, every 2 headache attack interval =48h; ?Patients who did not use migraine prophylactic drugs within 1 month before enrollment, or had used preventive drugs for more than 2 months and obtained stable effects; ? no acute therapeutic drugs were used within 48 hours; ?Negative neurological examination; ? can distinguish between migraine and other types of headache (such as tension headache); ? The informed consent was voluntarily signed or signed by the patient's immediate family members. Head CT or MRI should be performed to exclude headaches caused by intracranial organic diseases.

Exclusion criteria

Exclusion criteria: ? The number of headache days per month is greater than or equal to 15 days; ? Long-term users of painkillers or painkiller dependence (more than 10 days within 1 month); ? Nasal damage, serious rhinitis or nasal diseases affect the use of drugs; ? Patients with serious primary diseases of cardiovascular, liver, kidney, digestive and hematopoietic systems; ? People with epilepsy, stroke or other organic diseases of the nervous system or mental history; ?After examination and examination, it is actually an organic disease, such as subarachnoid haemorrhage, cerebral haemorrhage, cerebral infarction, vascular malformation, arteritis, hypertension, arteriosclerosis and other diseases caused by headache; ? Cognitive dysfunction, unable to read or understand the content of the scale, unable to cooperate with the doctor's treatment, possibly poor compliance (that is, can not adhere to the treatment) and difficulty completing the efficacy evaluation; ?Allergy, easy to be infected; ? Pregnant and lactating women; ? Participants in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with no headache 2 hours after medication;

Secondary

MeasureTime frame
Proportion of patients without headache;24-hour recurrence rate;48-hour recurrence rate;Concomitant symptom score;2h Headache relief rate;

Countries

China

Contacts

Public ContactKegang Cao

Dongzhimen Hosptial, Beijing University of Chinese Medicine

13121108767@163.com+86 131 2110 8767

Outcome results

None listed

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