Skip to main content
MedPathMedPath Home
Clinical Trials/CTRI/2018/01/011449
CTRI/2018/01/011449
Not yet recruiting
未知

A randomized controlled trial to compare the efficacy of pirfenidone with placebo in systemic sclerosis related interstitial lung disease

Post graduate institute of medical education and research0 sites0 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHealth Condition 1: null- systemic sclerosis with interstitial lung disease

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: null- systemic sclerosis with interstitial lung disease
Sponsor
Post graduate institute of medical education and research
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Post graduate institute of medical education and research

Eligibility Criteria

Inclusion Criteria

  • •1\.Patients with SSc as diagnosed by the American College of
  • •Rheumatology (ACR) criteria, 2013 \& patients with other connective tissue diseases
  • •who, in parallel, meet the ACR criteria for SSc
  • •2\. Presence of ILD on HRCT chest
  • •3\. FVC \>\= 50%
  • •4\. Duration of SSc for \<\=7 years, with onset defined as the appearance of the first nonRaynaudâ??s
  • •phenomenon.
  • •5\. DLCO 30% to 89% of predicted normal
  • •6\. Consenting for participating in study
  • •7\. Received no new immunosuppression for last 6 months (on stable doses of

Exclusion Criteria

  • •Change in immunosuppressant drugs (except low dose steroids i.e. prednisolone
  • •equivalent \<\=10 mg/day) for ILD in the previous 6 months.
  • •2\. Received biologics in the past
  • •3\. Persistent leukopenia or thrombocytopenia
  • •4\. Pregnant or breastfeeding females
  • •5\. Severe PAH (mean pulmonary arterial pressure \>55mmHg) requiring drug therapy
  • •6\. FEV1/FVC ratio \<\=65%
  • •7\. Uncontrolled congestive heart failure
  • •8\. Any other abnormalities noted on chest X\-ray or HRCT other than ILD
  • •9\. Active infection

Outcomes

Primary Outcomes

Not specified

Similar Trials

Recruiting
Not Applicable
A clinical interventional study to compare the efficacy of two combined non invasive brain stimulation as motor enhancement therapy for upper extremity in brain attack due to blocked blood vessel cases of more than six months.Health Condition 1: I633- Cerebral infarction due to thrombosis of cerebral arteries
CTRI/2019/11/022009JIPMER
Not yet recruiting
Phase 4
To study different pain relief modalities in preterm neonates during heel-stickHealth Condition 1: P84- Other problems with newborn
CTRI/2023/09/057787Bharati Vidyapeeth Deemed University Medical College, Pune
Not yet recruiting
Not Applicable
A study to compare the effectiveness of Pericapsular nerve group block versus erector spinae plane block for pain control after hip surgery
CTRI/2022/11/047702ady Hardinge Medical College
Completed
Not Applicable
Comparison of sodium excreting effect between furosemide and indapamide combination with furosemide and metolazone combination in congestive heart failure patientsCongestive Heart Failure
SLCTR/2017/041Rehman Medical Institute
Recruiting
Phase 2
A study to compare two medicines for lung disease in scleroderma patients- Tofacitinib ascompared to Mycophenolate MofetilHealth Condition 1: M340- Progressive systemic sclerosis
CTRI/2024/05/067540Post Graduate Institute of Medical Education and Research Chandigarh