Clinical Study of Jianfei Kangfu Cao in the Treatment of pSS-ILD

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of Jianfei Kangfu Cao in the treatment of primary Sjogren's syndrome associated interstitial lung disease.

Detailed Description
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This study will be a randomized, double-blind, positive control clinical trial with a course of 24 weeks. Random scheme:the DAS for Interactive Web Response System(IWRS) will be used to calculate and distribute random numbers and dispensing drugs. Blind method ：The test process will be in a double-blind state. Control drug: The lung rehabilitation training will be used as control in this trial.

Official Title
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Clinical Study of Jianfei Kangfu Cao in the Treatment of Primary Sjogren's Syndrome Associated Interstitial Lung Disease.

Conditions
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Primary Sjogren's Syndrome, Interstitial Lung Disease

Intervention / Treatment
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* Behavioral: Jianfei Kangfu Cao
* Behavioral: lung rehabilitation training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: According to the 2012 ACR classification of primary Sjogren's syndrome . CT confirmed interstitial lung disease; DLCO≧40%; Stable treatment for at least 12 weeks; Patients with good compliance should sign informed consent before the tria. Exclusion Criteria: The patient is using or has used anti pulmonary fibrosis drugs; Pulmonary infection, tumor and other connective tissue diseases; Chronic obstructive pulmonary disease, bronchial asthma and tuberculosis; Patients with severe hypertension, diabetes and heart, liver and renal failure; Women with reproductive needs; Idiopathic pulmonary interstitial disease; The researcher thinks that it is not suitable to participate in this experiment; Participants in other clinical trials.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jianfei Kangfu Cao<br>The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time. | Behavioral: Jianfei Kangfu Cao<br>* The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.<br>|
| Active Comparator: Lung rehabilitation training<br>The original treatment and the lung rehabilitation training, once a day, 30 minutes each time. | Behavioral: lung rehabilitation training<br>* The original treatment and the lung rehabilitation training, once a day, 30 minutes each time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FVC | FVC is an index of lung function. | 24 weeks | 
| CAT score | Cat questionnaire includes eight questions, the core of which is cough, expectoration, chest tightness, sleep, energy, emotion, and two tolerance evaluation indexes, namely, exercise endurance and daily exercise influence. According to the patient's own situation, each item was scored accordingly (0-5), and the cat score range was 0-40 | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6MWD | Six minutes walk test is a kind of exercise test for the functional state of patients with moderate and severe cardiopulmonary disease. | 24 weeks | 
| ESSDAI | Evaluation of Sjogren's disease activity | 24 weeks | 
| ESSPRI | EULAR SS Patient Reported Index | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Efficacy, Primary Sjogren's syndrome, Interstitial lung disease