Clinical Study of Jianfei Kangfu Cao in the Treatment of pSS-ILD
1 other identifier
interventional
138
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2020
CompletedFirst Posted
Study publicly available on registry
September 10, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMarch 1, 2021
August 1, 2020
1.9 years
September 4, 2020
February 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
6MWD
24 weeks
ESSDAI
24 weeks
ESSPRI
24 weeks
Study Arms (2)
Jianfei Kangfu Cao
EXPERIMENTALThe original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.
Lung rehabilitation training
ACTIVE COMPARATORThe original treatment and the lung rehabilitation training, once a day, 30 minutes each time.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200030, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhujing Zhu, Ph.D
Longhua Hospital
- STUDY CHAIR
Jianchun Mao, Master
Longhua Hospital
- STUDY CHAIR
Huanru Qu, Ph.D
Longhua Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2020
First Posted
September 10, 2020
Study Start
October 1, 2020
Primary Completion
September 1, 2022
Study Completion
June 1, 2023
Last Updated
March 1, 2021
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share