Idiopathic Pulmonary FibrosisNCT04187690
Jin-shui Huan-xian Granule in the Treatment of IPF
A study testing Jin-shui Huan-xian granule in people with Idiopathic Pulmonary Fibrosis, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study is to evaluate the efficacy and safety of Jin-shui Huan-xian granule for idiopathic pulmonary fibrosis (IPF), establish the treatment scheme, and obtain the high quality clinical evidences. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Jin-shui Huan-xian granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 30 Jul 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A confirmed diagnosis stable IPF.
- Age ranges from 40 years to 85 years.
- TCM Syndrome differentiation meets criteria of pattern of Lung Qi deficiency, yin deficiency and inter heat, and lung-kidney qi deficiency.
- Without participanting in any other trial.
- With signed informed consent.
Who cannot join
- Pregnant, nursing or may become pregnant women.
- Patients with unconscious, dementia or mental disorders.
- Patients with severe cardiac dysfunction.
- Patients with severe liver and kidney diseases.
- Patients with asthma, bronchiectasis, active pulmonary tuberculosis, pulmonary embolism, chronic obstructive pulmonary disease, chronic respiratory failure or other severe respiratory diseases.
- Patients with tumor after resection, radiotherapy or chemotherapy in the past 5 years.
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- Patients with severe neuromuscular disorders, severe arthritis or severe peripheral vascular diseases.
- Patients with long-term bedridden.
- Patients who are allergic to any of the treatment drugs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, 450000
Xue-qing Yu, Ph.D., +8613525518843, yxqshi@163.com
About this study
Official title: Efficacy and Safety of Jin-shui Huan-xian Granule in the Treatment of IPF
This study is to evaluate the efficacy and safety of Jin-shui Huan-xian granule for idiopathic pulmonary fibrosis (IPF), establish the treatment scheme, and obtain the high quality clinical evidences.
Read the detailed description
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive and ultimately fatal interstitial lung disease. With worsened dyspnea and an increasing loss of pulmonary function, IPF patients will have very poor quality of life. It has also brought an increasing social-economic burden. Researches show that pirfenidone and nintedanib could be effective to IPF, which were also recommended by the guideline. However, the application has been limited by side effects and high prices. It is urgent to develop other effective treatments and strategies to manage IPF. The investigators' previous studies shown that Jin-shui Huan-xian granule could be effective to IPF.
This is a multicerter, randomized, double-blind, placebo-controlled trial to assess the efficacy of Jin-shui Huan-xian granule in reducinig the acute exacerbations, improving exercise capacity, and delaying the disease progression for IPF. After a 2-week wash-out period, 312 patients will be randomly assigned into treatment or control group for 52-week treatment. The primary outcomes are frequencies of acute exacerbation, 6-minute walking test, and percentage of patients with progression-free survival. The secondary outcomes include pulmonary function, all-cause mortality, clinical symptoms, dyspnea score, and quality of life. Safety will also be evaluated.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Jin-shui Huan-xian granule, Jin-shui Huan-xian granule placebo
- Keywords
- Idiopathic Pulmonary Fibrosis, traditional Chinese medicine, randomized controlled trial
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jin-shui Huan-xian granuleDrug
Jin-shui Huan-xian granule will be administered 5days on and 2 days off for 52 weeks.
Jin-shui Huan-xian granule placeboDrug
Jin-shui Huan-xian granule placebo will also be administered 5days on and 2 days off for 52 weeks. The placebo consists 5% of the same components as Jin-shui Huan-xian granule besides dextrin and bitter. The There is no obvious difference in appearance, weight and odor between Jin-shui Huan-xian granule and placebo.
| Study group | Role | What they receive |
|---|---|---|
| Jin-shui Huan-xian granule | Experimental | Participants in this arm will be given Jin-shui Huan-xian granule. Receives: Drug: Jin-shui Huan-xian granule |
| Jin-shui Huan-xian granule placebo | Placebo comparator | Participants in this arm will be given Jin-shui Huan-xian granule placebo. Receives: Drug: Jin-shui Huan-xian granule placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequencies of acute exacerbations (AEs)
It will be assessed by frequencies of AEIPF-related hospitalizations.
Measured: up to 52 weeks.
Six-minute walking distance(6MWD)
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
Measured: Change from baseline 6MWD at week 13, 26, 39 and 52
Proportion of progressive-free survival
Endpoints of Progressive-free survival include FVC decreased by 10% compared with baseline, or DLCO% decreased by 15%, or death or lung transplantation.
Measured: up to week 13, 26, 39 and 52.
Secondary outcomes (8)
Pulmonary function
Forced vital capacity (FVC) and diffusing capacity percentage of the predicted value (DLco%) will be applied to assess pulmonary function.
Measured: Change from baseline FVC and DLco% at week 26 and 52.
All-cause mortality
The all-cause mortality will be calculated in each group at the end of the trial.
Measured: up to 52 weeks.
Clinical symptoms and Signs
Assessment will be performed by clinical symptom assessment questionnaire. The clinical symptoms to be evaluated in this study include cough, expectoration, chest tightness, shortness of breath, wheezing and cyanosis. A score of 0-3 will be given to every symptom or sign with a higher score indicating a worse conditoin.
Measured: Change from baseline clinical symptoms assessment questionnaire scores at week 13, 26, 39 and 52.
Dyspnea
Dyspnea will be assessed by modified Medical Research Council (mMRC) scores set up by American Thoracic Society. A score of 0-4 will be given according to the degree of immediate dyspnea. A higher score indicates a worse dyspnea.
Measured: Change from baseline mMRC scores at week 13, 26, 39 and 52.
COPD assessment test (CAT)
CAT will be used to evaluate quality of life. A total score of 0-40 will be given with a higher score indicating a worse condition.
Measured: Change from baseline CAT scores at week 13, 26, 39 and 52.
36-item short-form health survey (SF-36) total scores
SF-36 total scores will be used to evaluate quality of life with a total score of 0-100. The higher scores will indicate the better outcomes.
Measured: Change from baseline SF-36 scores at week 13, 26, 39 and 52.
St. George's respiratory questionnaire (SGRQ) total scores
SGRQ total scores will be used to evaluate quality of life with a total score of 0-100. The higher scores will indicate the worse outcomes.
Measured: Change from baseline SGRQ scores at week 13, 26, 39 and 52.
A Tool to Assess Quality of life in IPF(ATAQ-IPF)
ATAQ-IPF will be used to evaluate quality of life. There are 13 domains with 74 items with a score of 1-5 for each item. A higher score will indicate a worse health.
Measured: Change from baseline ATAQ scores at week 13, 26, 39 and 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Sep 2020
- Primary completion31 May 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian-sheng Li, Professor, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187690
- Sponsor's protocol ID
- TCM for IPF
- Status last verified
- Aug 2022
- First submitted
- 3 Dec 2019
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang SG, Yu XQ, Li JS, Xie Y, Zhang W, Ban C, Feng J, Wu L, Lu X, Zhao L, Meng Y, Zhou M, He Y, Luo W. Efficacy and safety of Jin-shui Huan-xian granule for idiopathic pulmonary fibrosis: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial. Trials. 2022 Sep 2;23(1):725. doi: 10.1186/s13063-022-06684-0.
PubMed 36056382
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Jin-shui Huan-xian Granule in the Treatment of IPF
- ClinicalTrials.gov ID
- NCT04187690
- Acronym / sponsor ID
- TCM for IPF
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis, traditional Chinese medicine, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 5 Dec 2019 (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 is to evaluate the efficacy and safety of Jin-shui Huan-xian granule for idiopathic pulmonary fibrosis (IPF), establish the treatment scheme, and obtain the high quality clinical evidences.
Detailed description
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive and ultimately fatal interstitial lung disease. With worsened dyspnea and an increasing loss of pulmonary function, IPF patients will have very poor quality of life. It has also brought an increasing social-economic burden. Researches show that pirfenidone and nintedanib could be effective to IPF, which were also recommended by the guideline. However, the application has been limited by side effects and high prices. It is urgent to develop other effective treatments and strategies to manage IPF. The investigators' previous studies shown that Jin-shui Huan-xian granule could be effective to IPF.
This is a multicerter, randomized, double-blind, placebo-controlled trial to assess the efficacy of Jin-shui Huan-xian granule in reducinig the acute exacerbations, improving exercise capacity, and delaying the disease progression for IPF. After a 2-week wash-out period, 312 patients will be randomly assigned into treatment or control group for 52-week treatment. The primary outcomes are frequencies of acute exacerbation, 6-minute walking test, and percentage of patients with progression-free survival. The secondary outcomes include pulmonary function, all-cause mortality, clinical symptoms, dyspnea score, and quality of life. Safety will also be evaluated.
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 |
|---|---|---|
| Jin-shui Huan-xian granule | Experimental | Drug: Jin-shui Huan-xian granuleParticipants in this arm will be given Jin-shui Huan-xian granule. |
| Jin-shui Huan-xian granule placebo | Placebo comparator | Drug: Jin-shui Huan-xian granule placeboParticipants in this arm will be given Jin-shui Huan-xian granule placebo. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A confirmed diagnosis stable IPF.
- Age ranges from 40 years to 85 years.
- TCM Syndrome differentiation meets criteria of pattern of Lung Qi deficiency, yin deficiency and inter heat, and lung-kidney qi deficiency.
- Without participanting in any other trial.
- With signed informed consent.
Key exclusion criteria (9 listed)
- Pregnant, nursing or may become pregnant women.
- Patients with unconscious, dementia or mental disorders.
- Patients with severe cardiac dysfunction.
- Patients with severe liver and kidney diseases.
- Patients with asthma, bronchiectasis, active pulmonary tuberculosis, pulmonary embolism, chronic obstructive pulmonary disease, chronic respiratory failure or other severe respiratory diseases.
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 |
|---|---|---|
| Jin-shui Huan-xian granuleJin-shui Huan-xian granule will be administered 5days on and 2 days off for 52 weeks. | Drug | Jin-shui Huan-xian granule |
| Jin-shui Huan-xian granule placeboJin-shui Huan-xian granule placebo will also be administered 5days on and 2 days off for 52 weeks. The placebo consists 5% of the same components as Jin-shui Huan-xian granule besides dextrin and bitter. The There is no obvious difference in appearance, weight and odor between Jin-shui Huan-xian granule and placebo. | Drug | Jin-shui Huan-xian granule placebo |
Primary outcome
Frequencies of acute exacerbations (AEs)
Time frame: up to 52 weeks.
It will be assessed by frequencies of AEIPF-related hospitalizations.
Six-minute walking distance(6MWD)
Time frame: Change from baseline 6MWD at week 13, 26, 39 and 52
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
Proportion of progressive-free survival
Time frame: up to week 13, 26, 39 and 52.
Endpoints of Progressive-free survival include FVC decreased by 10% compared with baseline, or DLCO% decreased by 15%, or death or lung transplantation.
8 secondary outcomes
Pulmonary function
Time frame: Change from baseline FVC and DLco% at week 26 and 52.
All-cause mortality
Time frame: up to 52 weeks.
Clinical symptoms and Signs
Time frame: Change from baseline clinical symptoms assessment questionnaire scores at week 13, 26, 39 and 52.
Dyspnea
Time frame: Change from baseline mMRC scores at week 13, 26, 39 and 52.
COPD assessment test (CAT)
Time frame: Change from baseline CAT scores at week 13, 26, 39 and 52.
36-item short-form health survey (SF-36) total scores
Time frame: Change from baseline SF-36 scores at week 13, 26, 39 and 52.
St. George's respiratory questionnaire (SGRQ) total scores
Time frame: Change from baseline SGRQ scores at week 13, 26, 39 and 52.
A Tool to Assess Quality of life in IPF(ATAQ-IPF)
Time frame: Change from baseline ATAQ scores at week 13, 26, 39 and 52.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Derived from this study: PubMed 36056382Yang SG, Yu XQ, Li JS, Xie Y, Zhang W, Ban C, Feng J, Wu L, Lu X, Zhao L, Meng Y, Zhou M, He Y, Luo W. Efficacy and safety of Jin-shui Huan-xian granule for idiopathic pulmonary fibrosis: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial. Trials. 2022 Sep 2;23(1):725. doi: 10.1186/s13063-022-06684-0.
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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.
Jian-sheng Li, Professor study chair
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jin-shui Huan-xian granule in people with Idiopathic Pulmonary Fibrosis, run by Henan 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 9 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 18 Aug 2022. 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. Some participants in this study may receive a placebo. 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 Xue-qing Yu, PhD (86-371-66248624, yxqshi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequencies of acute exacerbations (AEs) (time frame: up to 52 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04187690, which also lists 1 linked publication.
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 18 Aug 2022.