Pilot Study on the effectiveness of crocin as a drug supplement in the treatment of ocular complications of Behcet's disease; a clinical trial

Study is a double blind clinical trial for determination of the therapeutic effects of Crocin on patients with Behcet's disease.

In this double blind randomized trial with two arm parallel group, the crocin and placebo tablets were made in completely similar shape, color, and size

This study will be conducted in ِKhatam-al-Anbia hospital with ophthalmologist, also tablets will be produced from pure crocin at Mashhad Pharmacy School. In this double-blind trial, physician, researcher and patient will not be aware of distribution of tablets in crocin and control groups.

Including Criteria: A patient with Active Behcet's with ocular complications is selected according to the sun criteria, Patients with Behcet's syndrome with anterior, posterior, or diffuse eye involvement, Long-term illness of the eye with active retinal vasculitis and macular edema, Age over 18 years of both sexes A patient with Behcet's who is resistant (without improvement or exacerbation of the eye disease) or an approximate response (mild to moderate) to Combination therapy (Psychosis and Steroids drugs), The ability to understand the overall study. Exclusion Criteria: Patients with bilateral vision loss, Patients receiving anti-TNF drugs such as thalidomide in the past three months, Patients with a history of Weak immune system, Severe viral infections including hepatitis, pneumoniain the last three months, Pregnancy and breastfeeding, Sensitivity to saffron, alcohol consumption, Cataract and other general items, Diabetes

Treatment group: patients with Behçet's disease that receive 15 mg/day of crocin tablet for 3 months. Placebo group : patients with Behçet's disease that receive one Placebo tablet per day for 3 months.

Assessing the Rate of Ocular inflammation

For each tablet container, four-digit codes will be Randomly labeled to Each Box by pharmacist . The Therapist will give it to the Patient Randomly without Knowledge of the Type of Medicine. Thus, the nature of each code will not be known until the analysis of the results.

Crocin and placebo tablets will be prepared in a similar shape, color, and size, stored in a dark container and coded by a pharmacist. The physician, researcher and patients will not be aware of the code printed on the container.

As regards to that the work has not begun, a definitive decision on this information has not yet been taken.