Interstitial Lung Disease, Primary Sjogren's Syndrome
Conditions
Keywords
Safety, Efficacy, Primary Sjogren's syndrome, Interstitial lung disease
Brief summary
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
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.
Interventions
BEHAVIORALJianfei Kangfu Cao
The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.
BEHAVIORALlung rehabilitation training
The original treatment and the lung rehabilitation training, once a day, 30 minutes each time.
Sponsors
Shanghai University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. According to the 2012 ACR classification of primary Sjogren's syndrome . 2. CT confirmed interstitial lung disease; 3. DLCO≧40%; 4. Stable treatment for at least 12 weeks; 5. Patients with good compliance should sign informed consent before the tria.
Exclusion criteria
1. The patient is using or has used anti pulmonary fibrosis drugs; 2. Pulmonary infection, tumor and other connective tissue diseases; 3. Chronic obstructive pulmonary disease, bronchial asthma and tuberculosis; 4. Patients with severe hypertension, diabetes and heart, liver and renal failure; 5. Women with reproductive needs; 6. Idiopathic pulmonary interstitial disease; 7. The researcher thinks that it is not suitable to participate in this experiment; 8. Participants in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FVC | 24 weeks | FVC is an index of lung function. |
| CAT score | 24 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6MWD | 24 weeks | Six minutes walk test is a kind of exercise test for the functional state of patients with moderate and severe cardiopulmonary disease. |
| ESSDAI | 24 weeks | Evaluation of Sjogren's disease activity |
| ESSPRI | 24 weeks | EULAR SS Patient Reported Index |
Countries
China
Contacts
Primary ContactZhujing Zhu, Ph.D
Backup ContactJianchun Mao, Master
Outcome results
None listed