lung involvement in scleroderma. Respiratory disorders in other diffuse connective tissue disorders (systemic sclerosis)
Conditions
Interventions
Intervention 1: Intervention group: Tablets of Nacetylcysteine (NAC) are product of IRAN and 600mg. Therapy is with 1200 mg NAC daily that divided two times a day for six months. Intervention 2: Contr
Treatment - Drugs
Placebo
Intervention group: Tablets of Nacetylcysteine (NAC) are product of IRAN and 600mg. Therapy is with 1200 mg NAC daily that divided two times a day for six months.
Control group: Placebo will be given 2 times daily for 6 months.
Sponsors
Vice chancellor for research, Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Cases of diffuse scleroderma who fulfilled the ACR criteria for systemic sclerosis that diagnosis of their disease was made less than one year ago; No evidence of fibrosis in high rsolution CT scan (HRCT) Exclusion criteria: Lung involvement (deterioration of disease); Not properly usage of drug; Not regularly visits by cases in intervals and appointments that were determined for them; Not toleration of drug or probable allergic reactions to it (very rare reports); Clinical or serologic evidence of other collagen vascular disease; History of exposure to known fibrogenic agents; Previous use of immunosuppressive or corticosteroid therapy for a minimum of 6 months before entering the study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total lung capacity. Timepoint: At the beginning and 6 months following start of intervention. Method of measurement: Body plethysmography measured by litre.;Diffusing capacity. Timepoint: At the beginning and 6 months following start of intervention. Method of measurement: DLCO ml/min.;Vital capacity. Timepoint: At the beginning and 6 months following start of intervention. Method of measurement: Body plethysmography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse drug/placebo reaction. Timepoint: Every 2 months. Method of measurement: Ask from the patient. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSamrad Mehrabi
Shiraz University of Medical Sciences
Outcome results
None listed