Chronic respiratory disorders caused by chemical weapons (sulfur mustard
Conditions
Interventions
Intervention 1: In the control group, patients consume the standard treatment of Foreign NAC (Fluimucil) with a total daily dosage of 1800 mg (three times a day and each time a 600 mg effervescent ora
Treatment - Drugs
In the control group, patients consume the standard treatment of Foreign NAC (Fluimucil) with a total daily dosage of 1800 mg (three times a day and each time a 600 mg effervescent oral tablet) for fo
In the intervention group, patients consume the Iranian NAC (Oslyt) with a total daily dosage of 1800 mg (three times a day and each time a 600 mg effervescent oral tablet) for four months
Sponsors
Research deputy of Baqiyatallah University of Medical Sciences
Osvah Pharmaceutical Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: documented exposure to sulfur mustard; documented diagnosis of chronic pulmonary disease due to mustard gas (histological evidence from previous biopsies); no history of tuberculosis; no history of resection of one or more lobes of lung Exclusion criteria: pneumonia; acute bronchitis; smoking cigarettes; being a substance abuser; any illness in which the medications could not be stopped; occurrence of any severe side effects of N-acetylcysteine (anaphylactoid reaction); use of any kind of antioxidant drugs; deterioration of clinical conditions during the course of the study; consuming less than 80% of allocated NAC medication
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cough. Timepoint: Before intervention, four months after intervention (end of intervention). Method of measurement: likert scale from 1 to 5: 1=I did not have cough 2=I have cough, but it is not a serious problem 3=I have cough, sometimes disturbs my work 4=I have disturbing cough, usually disturbs my work 5=I have disturbing cough, always disturbs my work.;Dyspnea. Timepoint: Before intervention, four months after intervention (end of intervention). Method of measurement: likert scale from 1 to 5: 1=There is no dyspnea 2=Dyspnea only in extraordinary exercises 3=Dyspnea in ordinary exercise 4=Dyspnea in mild exercise 5=Dyspnea in rest. | — |
Secondary
| Measure | Time frame |
|---|---|
| Wake-up dyspnea. Timepoint: Before intervention, four months after intervention (end of intervention). Method of measurement: likert scale from 1 to 4: 1=I never woke up due to dyspnea 2=I wake up less than once a week 3=I wake up once a week 4=I wake up more than twice a week.;Side effects of Iranian NAC (Oslyt) and Foreign NAC (Fluimucil). Timepoint: At the end of the second week of the trial. Method of measurement: At the end of the second week of the trial and in a clinical visit, patients in both groups were asked about the side effects of NAC including nausea, vomiting, unpleasant taste of tablet, gastrointestinal distress, diarrhea, constipation and symptoms related to anaphylactoid reactions like urticaria, rash, suffocation feeling, dysphagia, dizziness, reduced blood pressure, pruritus and etc.;Sputum. Timepoint: Before intervention, four months after intervention (end of intervention). Method of measurement: Sputum was reported as 0 for absence and 1 for presence.;Delta Cough. Timepoint: Four months after intervention (end of intervention). Method of measurement: Cough Score at month 4 minus cough score at month 0.;Delta dyspnea. Timepoint: Four months after intervention (end of intervention). Method of measurement: Dyspnea Score at month 4 minus dyspnea score at month 0.;Delta Wake-up dyspnea. Timepoint: Four months after intervention (end of intervention). Method of measurement: Wake-up Dyspnea Score at month 4 minus wake-up dyspnea score at month 0.;FEV1. Timepoint: Before intervention, two months after intervention, four months after intervention (end of intervention). Method of measurement: Measured by a HI-801 Chest M.I. Spirometer, Tokyo, Japan and unit of measurement is liter.;FVC. Timepoint: Before intervention, two months after intervention, four months after intervention (end of intervention). Method of measurement: Measured by a HI-801 Chest M.I. Spirometer, Tokyo, Japan and unit of measurement is liter.;FEV1/FVC. Timepoint: Before interventio | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Yunes Panahi
Baqiyatallah University of Medical Sciences-Chemical Injuries Research Center
Outcome results
None listed