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

Interstitial Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04544722
• Other study ID #: Jianfei Kangfu Cao
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: August 2020
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Zhujing Zhu, Ph.D
• Phone: +8613816914874
• Email: zzj01[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: June 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Primary Sjogren's Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Behavioral:
• Jianfei Kangfu Cao
The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.
• lung rehabilitation training
The original treatment and the lung rehabilitation training, once a day, 30 minutes each time.

Locations

Country	Name	City	State
China	Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FVC	FVC is an index of lung function.	24 weeks
Primary	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	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
Secondary	ESSDAI	Evaluation of Sjogren's disease activity	24 weeks
Secondary	ESSPRI	EULAR SS Patient Reported Index	24 weeks