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

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

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

Study Overview

• Status: Recruiting
• Conditions: Interstitial Lung Disease; Primary Sjogren's Syndrome
• Intervention / Treatment: Behavioral: Jianfei Kangfu Cao; Behavioral: lung rehabilitation training

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 Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianchun Mao, Master; Phone Number: +8618917763231; Email: mjczyczx@163.com
• Study Contact Backup: Name: Zhujing Zhu, Ph.D; Phone Number: +8613816914874; Email: zzj01@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
      • Contact: Jianchun Mao, master; Phone Number: 86-18917763231; Email: mjcct2018@163.com

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FVC	FVC is an index of lung function.	24 weeks
CAT score	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	24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Investigators: Study Chair: Huanru Qu, Ph.D, Longhua Hospital; Principal Investigator: Zhujing Zhu, Ph.D, Longhua Hospital; Study Chair: Jianchun Mao, Master, Longhua Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Interstitial lung disease; Primary Sjogren's syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Lung Diseases; Lung Diseases, Interstitial; Sjogren's Syndrome
• Other Study ID Numbers: Jianfei Kangfu Cao

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No