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

• ClinicalTrials.gov Identifier: NCT04544722
• Recruitment Status: Recruiting
• First Posted: September 10, 2020
• Last Update Posted: March 1, 2021
• Sponsor: Shanghai University of Traditional Chinese Medicine
• Information provided by (Responsible Party): Shanghai University of Traditional Chinese Medicine

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	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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: October 1, 2020
• Estimated Primary Completion Date: September 1, 2022
• Estimated Study Completion Date: June 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.

Outcome Measures

Primary Outcome Measures :

1. FVC [ Time Frame: 24 weeks ]
   FVC is an index of lung function.
2. CAT score [ Time Frame: 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 :

1. 6MWD [ Time Frame: 24 weeks ]
   Six minutes walk test is a kind of exercise test for the functional state of patients with moderate and severe cardiopulmonary disease.
2. ESSDAI [ Time Frame: 24 weeks ]
   Evaluation of Sjogren's disease activity
3. ESSPRI [ Time Frame: 24 weeks ]
   EULAR SS Patient Reported Index

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Zhujing Zhu, Ph.D; +8613816914874; zzj01@hotmail.com

Contact: Jianchun Mao, Master; +8618917763231; mjczyczx@163.com

Locations

China, Shanghai

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine; Recruiting

Shanghai, Shanghai, China, 200030

Contact: Jianchun Mao, master 86-18917763231 mjcct2018@163.com

Sponsors and Collaborators

Shanghai University of Traditional Chinese Medicine

Investigators

• Principal Investigator: Zhujing Zhu, Ph.D; Longhua Hospital
• Study Chair: Jianchun Mao, Master; Longhua Hospital
• Study Chair: Huanru Qu, Ph.D; Longhua Hospital

More Information

• Responsible Party: Shanghai University of Traditional Chinese Medicine
• ClinicalTrials.gov Identifier: NCT04544722
• Other Study ID Numbers: Jianfei Kangfu Cao
• First Posted: September 10, 2020
• Last Update Posted: March 1, 2021
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai University of Traditional Chinese Medicine:

Safety; Efficacy; Primary Sjogren's syndrome; Interstitial lung disease

Additional relevant MeSH terms:

Sjogren's Syndrome; Lung Diseases; Lung Diseases, Interstitial; Syndrome; Disease; Pathologic Processes; Respiratory Tract Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases