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

Sponsor

Shanghai University of Traditional Chinese Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT04544722

Collaborator

(none)

138

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Sjogren's Syndrome Interstitial Lung Disease	Behavioral: Jianfei Kangfu Cao Behavioral: lung rehabilitation training	N/A

Detailed Description

This study will be a randomized, double-blind, positive control clinical trial with a course of 24 weeks.

Random scheme:the DAS for Interactive Web Response System(IWRS) will be used to calculate and distribute random numbers and dispensing drugs.
Blind method ：The test process will be in a double-blind state.
Control drug: The lung rehabilitation training will be used as control in this trial.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Clinical Study of Jianfei Kangfu Cao in the Treatment of Primary Sjogren's Syndrome Associated Interstitial Lung Disease.

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Jianfei Kangfu Cao The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.	Behavioral: Jianfei Kangfu Cao The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.
Active Comparator: Lung rehabilitation training The original treatment and the lung rehabilitation training, once a day, 30 minutes each time.	Behavioral: lung rehabilitation training The original treatment and the lung rehabilitation training, once a day, 30 minutes each time.

Arm

Intervention/Treatment

Experimental: Jianfei Kangfu Cao

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

Behavioral: Jianfei Kangfu Cao

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

Active Comparator: Lung rehabilitation training

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

Behavioral: lung rehabilitation training

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

According to the 2012 ACR classification of primary Sjogren's syndrome .
CT confirmed interstitial lung disease;
DLCO≧40%;
Stable treatment for at least 12 weeks;
Patients with good compliance should sign informed consent before the tria.

Exclusion Criteria:

The patient is using or has used anti pulmonary fibrosis drugs;
Pulmonary infection, tumor and other connective tissue diseases;
Chronic obstructive pulmonary disease, bronchial asthma and tuberculosis;
Patients with severe hypertension, diabetes and heart, liver and renal failure;
Women with reproductive needs;
Idiopathic pulmonary interstitial disease;
The researcher thinks that it is not suitable to participate in this experiment;
Participants in other clinical trials.