Back to resultsClinical Study of Jianfei Kangfu Cao in the Treatment of pSS-ILD
Primary Purpose
Primary Sjogren's Syndrome, Interstitial Lung Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Jianfei Kangfu Cao
lung rehabilitation training
Sponsored by
About this trial
This is an interventional treatment trial for Primary Sjogren's Syndrome focused on measuring Safety, Efficacy, Primary Sjogren's syndrome, Interstitial lung disease
Eligibility Criteria
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.
Sites / Locations
- Longhua Hospital Affiliated to Shanghai University of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Jianfei Kangfu Cao
Lung rehabilitation training
Arm Description
The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.
The original treatment and the lung rehabilitation training, once a day, 30 minutes each time.
Outcomes
Primary Outcome Measures
FVC
FVC is an index of lung function.
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
Secondary Outcome Measures
6MWD
Six minutes walk test is a kind of exercise test for the functional state of patients with moderate and severe cardiopulmonary disease.
ESSDAI
Evaluation of Sjogren's disease activity
ESSPRI
EULAR SS Patient Reported Index
Full Information
NCT ID
NCT04544722
First Posted
September 4, 2020
Last Updated
February 24, 2021
Sponsor
Shanghai University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04544722
Brief Title
Clinical Study of Jianfei Kangfu Cao in the Treatment of pSS-ILD
Official Title
Clinical Study of Jianfei Kangfu Cao in the Treatment of Primary Sjogren's Syndrome Associated Interstitial Lung Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sjogren's Syndrome, Interstitial Lung Disease
Keywords
Safety, Efficacy, Primary Sjogren's syndrome, Interstitial lung disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Jianfei Kangfu Cao
Arm Type
Experimental
Arm Description
The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.
Arm Title
Lung rehabilitation training
Arm Type
Active Comparator
Arm Description
The original treatment and the lung rehabilitation training, once a day, 30 minutes each time.
Intervention Type
Behavioral
Intervention Name(s)
Jianfei Kangfu Cao
Intervention Description
The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.
Intervention Type
Behavioral
Intervention Name(s)
lung rehabilitation training
Intervention Description
The original treatment and the lung rehabilitation training, once a day, 30 minutes each time.
Primary Outcome Measure Information:
Title
FVC
Description
FVC is an index of lung function.
Time Frame
24 weeks
Title
CAT score
Description
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
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
6MWD
Description
Six minutes walk test is a kind of exercise test for the functional state of patients with moderate and severe cardiopulmonary disease.
Time Frame
24 weeks
Title
ESSDAI
Description
Evaluation of Sjogren's disease activity
Time Frame
24 weeks
Title
ESSPRI
Description
EULAR SS Patient Reported Index
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhujing Zhu, Ph.D
Phone
+8613816914874
Email
zzj01@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianchun Mao, Master
Phone
+8618917763231
Email
mjczyczx@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhujing Zhu, Ph.D
Organizational Affiliation
Longhua Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianchun Mao, Master
Organizational Affiliation
Longhua Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Huanru Qu, Ph.D
Organizational Affiliation
Longhua Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianchun Mao, master
Phone
86-18917763231
Email
mjcct2018@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of Jianfei Kangfu Cao in the Treatment of pSS-ILD
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