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

Shanghai University of Traditional Chinese Medicine

Status: Unknown

Conditions: Interstitial Lung Disease; Primary Sjogren's Syndrome

Treatments: Behavioral: lung rehabilitation training; Behavioral: Jianfei Kangfu Cao

Study type: Interventional

Funder types: Other

Identifiers

NCT04544722

Jianfei Kangfu Cao

Details and patient eligibility

About

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

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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138 participants in 2 patient groups

Jianfei Kangfu Cao

Experimental group

Description:

The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.

Treatment:

Behavioral: Jianfei Kangfu Cao

Lung rehabilitation training

Active Comparator group

Description:

The original treatment and the lung rehabilitation training, once a day, 30 minutes each time.

Treatment:

Behavioral: lung rehabilitation training