Clinical trials-Phase I
In the first stage, 55 volunteers have referred to be treated. Due to exclusion criteria, 30 volunteer patients are included and have taken part in the clinical trials. Only 25 patients have completed the treatment according to the procedure. The other five have been omitted. The clinical trials have been performed based on the criteria of the International headache society (IHS).
A questionnaire has been designed and the patients have been under supervision and evaluation for one month before and six months after treatment. The treatment was implemented as a 20-minute inhaling of the drug steam, once a day, within a period of 20 consecutive days. For the clinical trials, 2 beds in Hospital1 and 2 beds in Hospital2 have been allocated. The results have indicated significant treatment impacts of Migraine Spray on migraine headaches.
In the second stage, 210 patients have been treated by Migraine Spray in ArameshClinic, a multi-professional pain clinic. In this stage two major point is examined as follows:
- A spectrum of doses has been tried due to this verity of migraine headaches and weight of patients. The effective doses were finalized and prescribed for the patients in the clinical trials- Phase II. The results are presented in the second part of this report.
- Three treatment protocols by Migraine Spray have also been developed with similar efficacy. These protocols also have been prescribed for the patients in the clinical trials- Phase II.