Evaluation of antioxidant effects of NAC and vitamin B6 in comparison with NAC and placebo, in chemical warfare victims Chronic pulmonary lesions

Evaluation of antioxidant effects of NAC and vitamin B6 in comparison with NAC alone, in chemical warfare victims Chronic pulmonary lesions

This study is a randomized, double-blinded, placebo-controlled, parallel, clinical trial, in which 56 War chemical gas victims with chronic lung lesions, who will consciously and freely satisfy to participate in the study, will be entered the trial and accidentally will be assigned to intervention or control group, then be monitored for 6 weeks.

Patients will randomly assigned to intervention or control group and, according to their group's protocol, will take the medication for 6 weeks. Prior to the intervention, patients' demographic information and chemical ware gas history, quality of life, and levels of oxidative stress biomarkers will recorded. Six weeks later, at the end of the study, the following will be reviewed.

Inclusion criteria: Chronic lung lesions caused by war chemical gases have been proven; According to the patient's spirometry results, the pulmonary injury is not severe; The patient should have freely informed written consent to participate in the study. Exclusion criteria: Suffering from lung function-related diseases of lung origin, including asthma, bronchiectasis, etc. Suffering from lung function-related diseases of non-lung origin, including ALS, kyphosis, etc.

In intervention group, patients will receive 600 mg of NAC effervescent tablets, 3 times a day, and Tablet vitamin B6 50 mg once daily for 6 weeks. In control group, patients will receive 600 mg of NAC effervescent tablets, 3 times a day, and Tablet vitamin B6 placebo once daily for 6 weeks.

Spirometry parameters changes

Block Randomization method is used to randomized the patients. For randomization, we visited the www.sealedenvelope.com, then randomization tab and make a list option were selected, the number of intervention groups, sample size, block size (which was selected due to the small sample size, 4 )were entered the intended locations, then a random list containing the pattern of patient allocation was obtained in two intervention groups.

Both patients and physicians participating in this clinical trial are blinded about the prescribed type of drug (main drug / placebo).