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

Not Applicable

• Conditions: Primary Sjogren's Syndrome; Interstitial Lung Disease
• Interventions: Behavioral: lung rehabilitation training; Behavioral: Jianfei Kangfu Cao

• Registration Number: NCT04544722
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

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.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-10
• Study Start: 2020-10-01
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-03-01
• Primary Completion: 2022-09-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lung rehabilitation training	lung rehabilitation training	The original treatment and the lung rehabilitation training, once a day, 30 minutes each time.
Jianfei Kangfu Cao	Jianfei Kangfu Cao	The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China