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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04544722
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Shanghai University of Traditional Chinese Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Zhujing Zhu, Ph.DJianchun Mao, MasterHuanru Qu, Ph.D
Principal Investigator Affiliation	Longhua HospitalLonghua HospitalLonghua Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Primary Sjogren's Syndrome, Interstitial Lung Disease

Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Interventions

Behavioral: - Jianfei Kangfu Cao

The original treatment and Jianfei Kangfu Cao, 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.