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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.
This study will be a randomized, double-blind, positive control clinical trial with a course of 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jianfei Kangfu Cao | Experimental | The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time. |
|
| Lung rehabilitation training | Active Comparator | The original treatment and the lung rehabilitation training, once a day, 30 minutes each time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jianfei Kangfu Cao | Behavioral | The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhujing Zhu, Ph.D | Contact | +8613816914874 | zzj01@hotmail.com | |
| Jianchun Mao, Master | Contact | +8618917763231 | mjczyczx@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhujing Zhu, Ph.D | Longhua Hospital | Principal Investigator |
| Jianchun Mao, Master | Longhua Hospital | Study Chair |
| Huanru Qu, Ph.D |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| lung rehabilitation training | Behavioral | The original treatment and the lung rehabilitation training, once a day, 30 minutes each time. |
|
| 24 weeks |
| ESSPRI | EULAR SS Patient Reported Index | 24 weeks |
| Longhua Hospital |
| Study Chair |