Primary Sjogren's SyndromeNCT04544722
Clinical Study of Jianfei Kangfu Cao in the Treatment of pSS-ILD
A study testing Jianfei Kangfu Cao and lung rehabilitation training in people with Primary Sjogren's Syndrome and Interstitial Lung Disease, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sjogren's Syndrome, Interstitial Lung Disease
- What is being tested?
- Jianfei Kangfu Cao and lung rehabilitation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200030
Jianchun Mao, master, 86-18917763231, mjcct2018@163.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Jianfei Kangfu Cao, lung rehabilitation training
- Keywords
- Safety, Efficacy, Primary Sjogren's syndrome, Interstitial lung disease
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jianfei Kangfu CaoBehavioural
The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.
lung rehabilitation trainingBehavioural
The original treatment and the lung rehabilitation training, once a day, 30 minutes each time.
| Study group | Role | What they receive |
|---|---|---|
| Jianfei Kangfu Cao | Experimental | The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time. Receives: Behavioral: Jianfei Kangfu Cao |
| Lung rehabilitation training | Active comparator | The original treatment and the lung rehabilitation training, once a day, 30 minutes each time. Receives: Behavioral: lung rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC
FVC is an index of lung function.
Measured: 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
Measured: 24 weeks
Secondary outcomes (3)
6MWD
Six minutes walk test is a kind of exercise test for the functional state of patients with moderate and severe cardiopulmonary disease.
Measured: 24 weeks
ESSDAI
Evaluation of Sjogren's disease activity
Measured: 24 weeks
ESSPRI
EULAR SS Patient Reported Index
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Oct 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjogren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhujing Zhu, Ph.D, Principal investigator, Longhua HospitalJianchun Mao, Master, Study chair, Longhua HospitalHuanru Qu, Ph.D, Study chair, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544722
- Sponsor's protocol ID
- Jianfei Kangfu Cao
- Status last verified
- Aug 2020
- First submitted
- 4 Sep 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Jianfei Kangfu Cao in the Treatment of Primary Sjogren's Syndrome Associated Interstitial Lung Disease.
- ClinicalTrials.gov ID
- NCT04544722
- Acronym / sponsor ID
- Jianfei Kangfu Cao
- Keywords
- Safety, Efficacy, Primary Sjogren's syndrome, Interstitial lung disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jianfei Kangfu Cao | Experimental | Behavioral: Jianfei Kangfu CaoThe original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time. |
| Lung rehabilitation training | Active comparator | Behavioral: lung rehabilitation trainingThe original treatment and the lung rehabilitation training, once a day, 30 minutes each time. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jianfei Kangfu CaoThe original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time. | Behavioural | Jianfei Kangfu Cao |
| lung rehabilitation trainingThe original treatment and the lung rehabilitation training, once a day, 30 minutes each time. | Behavioural | Lung rehabilitation training |
Primary outcome
FVC
Time frame: 24 weeks
FVC is an index of lung function.
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
3 secondary outcomes
6MWD
Time frame: 24 weeks
ESSDAI
Time frame: 24 weeks
ESSPRI
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhujing Zhu, Ph.D principal investigator
Longhua Hospital
Jianchun Mao, Master study chair
Longhua Hospital
Huanru Qu, Ph.D study chair
Longhua Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jianfei Kangfu Cao and lung rehabilitation training in people with Primary Sjogren's Syndrome and Interstitial Lung Disease, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhujing Zhu, Ph.D (+8613816914874, zzj01@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FVC (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.