This study will evaluate the safety and efficacy of Jianfei Kangfu Cao in the treatment of primary Sjogren's syndrome associated interstitial lung disease.
This study will be a randomized, double-blind, positive control clinical trial with a course of 24 weeks. 1. Random scheme:the DAS for Interactive Web Response System(IWRS) will be used to calculate and distribute random numbers and dispensing drugs. 2. Blind method :The test process will be in a double-blind state. 3. Control drug: The lung rehabilitation training will be used as control in this trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
138
The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.
The original treatment and the lung rehabilitation training, once a day, 30 minutes each time.
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGFVC
FVC is an index of lung function.
Time frame: 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
Time frame: 24 weeks
6MWD
Six minutes walk test is a kind of exercise test for the functional state of patients with moderate and severe cardiopulmonary disease.
Time frame: 24 weeks
ESSDAI
Evaluation of Sjogren's disease activity
Time frame: 24 weeks
ESSPRI
EULAR SS Patient Reported Index
Time frame: 24 weeks
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