A Randomized, Placebo-Controlled, Double-blind Study of Tianshu Capsule in the Treatment of Migraine.

Jiangsu Kanion Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Migraine

Treatments

Drug: Tianshu capsule

Drug: Sugar pill

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02035111

Z-TSJN-JN-Ⅳ

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache.

Full description

Primary headache disorders,particularly migraine is globally prevalent. Many studies show the burdens they impose: pain, disability, reduced quality of life (QoL), marked impairment of participation in work and social activities, and heavy financial costs.

The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache. To provide a safe and effective treatment of Migraine Headache.

Enrollment

947 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must meet the Migraine diagnosis.
Age of onset should be before age 50 years.
Migraine must have been occurring for 1 year preceding entry into the trial.
The number of migraine attack should be no less than 6 for a period of 3 months prior to Screening stage.
The number of migraine days is to be 2-8 for a period of 1 month prior to screening for entry into the trial.
Migraine days should be less than 15 for a period of 1 month prior to screening for entry into the trial.
Ages 18-65.
Participant can understand and complete the Headache diary.
All participants signed the informed consent.

Exclusion criteria

Other migraine prophylactic medication is continued 3 months prior to the drug trial.
Participants who have taken Tianshu capsule during 1 month prior to Screening stage.
The number of acute treatment for migraine is more than 10 per month.
Participants who have taken antipsychotics or antidepressant medications (unless only for migraine prophylaxis) during the previous 3 months.
Participants who abuse alcohol or other drugs.
Participants who are resistant to all acute migraine drugs prescribed optimally.
hypotension or uncontrolled hypertension.
Severe infections.
Malignancy.
Significant medical history of such as cardiac disease, cerebrovascular disease, liver disease, nephropathy etc.
Known allergies or serious side effects with Tianshu capsule in the past.
Breastfeeding, pregnant and potentially fertile women participant.
History of cluster headaches, tension-type headache, vascular headache with non-migraine, drug - dependence headache.
Secondary headaches, including hypertension, post-traumatic brain syndrome etc.
Participants who have taken migraine prophylactic medication regularly during 1 month prior to Screening stage.
Participants who are taking part in other clinical trials.