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临床试验/CTRI/2024/11/076712
CTRI/2024/11/076712尚未招募不适用

Study of clinical profile and severity in connective tissue disease-interstitial lung disease(CTD-ILD)

Department of General Medicine1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To Study the pattern of involvement of lung in various CTD-ILD (Connective Tissue Disease- related Interstitial Lung Disease)and IPAF (Interstitial pneumonia with autoimmune features)

研究概览

简要总结

After Obtaining Due Permission and Clearance From the Departments Involved (Ethics Committee), the Patients Meeting the Inclusion Criteria, After Ruling Out the Exclusion Criteria Will Be Recruited into the Study After Obtaining Their Informed Consent. The Clinical and Laboratory Data, Including Presenting Complaints, Relevant Examination Findings, Blood Investigation Reports Involving Autoimmune Workup (Ana Global, Ana Profile), Rdw(Red cell distribution width), Neutrophil-Lymphocyte Ratio (NLR) Along With Hrct, ( PFT)Pulmonary Function Test, Dlco (Diffusing Capacity of the Lungs for Carbon Monoxide) Findings, and Additional Imaging Findings as Applicable, Will Be Tabulated in a Pre-designed Proforma. The Findings of Imaging- Xray and HRCT done as a Standard of Routine Care Are Noted to Look for Diagnosis and Severity. In Case a Recruited Participant Has Multiple Visits During the Study Period, Relevant. Additional Details Like Disease Progression and New Findings in Blood Investigations, HRCT, or Imaging Will Be Noted

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • INCLUSION CRITERIA:
  • Patients who have a confirmed diagnosis of interstitial lung disease(ILD) associated with a known(CTD) connective tissue disease (e.g. rheumatoid arthritis, systemic sclerosis, dermatomyositis etc.).
  • Clinical Parameters: Individuals displaying relevant clinical symptoms such as cough, dyspnea (shortness of breath), fatigue, and evidence of lung involvement on imaging studies.
  • Confirmed Connective Tissue Disease: Patients diagnosed with a connective tissue disease with supportive evidence of Antibodies.
  • Patients Age ABOVE 18 years
  • diagnosed with any of the below mentioned connective tissue disorders:
  • Systemic Sclerosis
  • Systemic Lupus Erythematosus/SLE
  • Mixed Connective Tissue Disease (MCTD)
  • Rheumatoid Arthritis/RA
  • Inflammatory myositis- Dermatomyositis/Polymyositis
  • Sjogren’s disease
  • Undifferentiated Connective Tissue Disease (UCTD).

排除标准

  • Other Lung Diseases: Exclude individuals with lung diseases not associated with connective tissue disorders, such as chronic obstructive pulmonary disease (COPD) or pulmonary fibrosis unrelated to CTDs.
  • Drug-induced lung disease(like methotrexate induced)
  • Malignancy 4.Pregnant females
  • Active infections and comorbidities including congestive heart failure, renal and liver failure.

结局指标

主要结局

To Study the pattern of involvement of lung in various CTD-ILD (Connective Tissue Disease- related Interstitial Lung Disease)and IPAF (Interstitial pneumonia with autoimmune features)

时间窗: From the date of admission to date of discharge, and also follow-up during opd visits

and to correlate the CTD(Connective Tissue Disease) pattern of ILD (Interstitial Lung Disease) with AUTOIMMUNE PROFILE

时间窗: From the date of admission to date of discharge, and also follow-up during opd visits

次要结局

  • To Assess the severity of the CTD-ILD (Connective Tissue- Interstitial Lung Disease) with the various markers including DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide )/ RDW (red cell distribution width)/ CRP (C-Reactive Protein ) /NLR (neutrophil/lymphocyte ratio)(To correlate CT pulmonary grading with DCLO (Diffusing Capacity of the Lungs for Carbon Monoxide )/PFT (Pulmonary Function Test))

研究者

发起方
Department of General Medicine
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr I Sri Hanuman

Kasturba Medical College , Manipal

研究点 (1)

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