Idiopathic Pulmonary Fibrosis(IPF)NCT06914713
Jin-shui Huan-xian Formula for Retarding the Decline of Pulmonary Function in IPF
A study testing Jin-shui Huan-xian granule in people with Idiopathic Pulmonary Fibrosis(IPF), run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study is to evaluate the clinical efficacy and safety of Jin-shui Huan-xian Formula in retarding the decline of pulmonary function in IPF, generate high - quality clinical evidence, and establish a treatment plan of Jin-shui Huan-xian Formula for retarding the decline of pulmonary function in Idiopathic Pulmonary… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis(IPF)
- What is being tested?
- Jin-shui Huan-xian granule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 384 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2025to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients who meet the diagnostic criteria for IPF.
- Pulmonary function: The percentage of forced vital capacity (FVC) to the predicted value is ≥ 50%; and the percentage of the diffusing capacity of the lung for carbon monoxide (DLCO) to the predicted value is ≥ 30%.
- Patients who meet the syndrome - differentiation criteria for lung - qi deficiency syndrome, lung - and - kidney qi deficiency syndrome, etc.
- Aged between 40 and 85 years old.
- Patients who voluntarily accept the treatment and sign the informed consent
Who cannot join
- Patients in the acute exacerbation phase of IPF.
- Patients complicated with other pulmonary diseases such as chronic obstructive pulmonary disease (COPD), lung cancer, active pulmonary tuberculosis, bronchiectasis, and pulmonary embolism.
- Patients with severe joint, peripheral nerve, and peripheral vascular diseases that affect limb movement and who are bed - ridden for a long time and cannot complete the six - minute walk test.
- Patients complicated with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, heart function grade 3 or above, stroke, cerebral hemorrhage, etc.).
- Patients complicated with liver diseases such as cirrhosis or secondary portal hypertension, bleeding caused by esophageal and gastric varices, patients with kidney diseases requiring dialysis or kidney transplantation, or patients with abnormal liver and kidney functions (ALT, AST, and BUN are 1.5 times higher than the upper limit of the normal range, and blood Cr is higher than the upper limit of the normal range).
- Patients with unclear consciousness, various mental illnesses, etc., who cannot communicate normally.
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- Pregnant or lactating women and patients with a recent plan for pregnancy.
- Patients who have participated in other clinical trials within 1 month before enrollment.
- Patients known to be allergic to any of the test medications and their components.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, 450056
Ming-Hang Wang, Ph.D, +8618638392188, wmh107hn@163.com
About this study
Official title: Efficacy Evaluation of Jin-shui Huan-xian Formula in Retarding the Decline of Pulmonary Function in IPF
This study is to evaluate the clinical efficacy and safety of Jin-shui Huan-xian Formula in retarding the decline of pulmonary function in IPF, generate high - quality clinical evidence, and establish a treatment plan of Jin-shui Huan-xian Formula for retarding the decline of pulmonary function in Idiopathic Pulmonary Fibrosis（IPF）
Read the detailed description
This study will enroll 384 patients with idiopathic pulmonary fibrosis (IPF) and adopts a randomized, quadruple-masked, placebo-controlled trial design. Participants will be randomly assigned to either an experimental group or a control group. On the basis of guideline-directed standard treatment, the experimental group will receive Jin-shui Huan-xian Formula, while the control group will receive a matching placebo. Participants, care providers, investigators, and outcome assessors will remain blinded to treatment allocation. The treatment duration is 52 weeks. Forced vital capacity (FVC) is the primary outcome measure, while acute exacerbations, other pulmonary function parameters (including DLCO and DLCO%), exercise capacity, and quality of life are secondary outcome measures. Safety assessments include routine blood tests, urinalysis, liver function, renal function, and electrocardiography. The study aims to evaluate the efficacy and safety of Jin-shui Huan-xian Formula in slowing the decline in pulmonary function in patients with IPF and to generate high-quality clinical evidence for its use as an adjunctive treatment.
- Conditions
- Idiopathic Pulmonary Fibrosis(IPF)
- Being tested
- Jin-shui Huan-xian granule, Jin-shui Huan-xian granule placebo
- Keywords
- Idiopathic Pulmonary Fibrosis, traditional Chinese medicine, randomized controlled trial, pulmonary function
- 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
Also called Jin-shui Huan-xian Granules
Jin-shui Huan-xian Granules: on the basis of treatment guided by "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline ", the experimental group was given Jin-shui Huan-xian Granules for treatment. The granules were taken orally, 1 dose per day, twice a day, and the continuous administration lasted for 52 weeks.
Jin-shui Huan-xian granule placeboDrug
Jin-shui Huan-xian granule placebo: on the basis of treatment guided by "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline ", the experimental group was given Jin-shui Huan-xian Granules placebo for treatment. The granules were taken orally, 1 dose per day, twice a day, and the continuous administration lasted for 52 weeks.The Jin-shui Huan-xian granules and their placebo are identical in appearance, weight, color and smell.
| Study group | Role | What they receive |
|---|---|---|
| Jin-shui Huan-xian granule in addition to the guideline - directed treatment. | Experimental | The experimental group was given Jin-shui Huan-xian Formula in addition to the treatment guided by the guideline "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline ". Receives: Drug: Jin-shui Huan-xian granule |
| Jin-shui Huan-xian granule placebo in addition to the guideline - directed treatment. | Placebo comparator | Participants in the control group will receive Jin-shui Huan-xian granule placebo in addition to guideline-directed treatment based on the "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. 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.
Forced vital capacity (FVC)
FVC will be used to assess pulmonary function.
Measured: The change in absolute FVC value before treatment and at 52 weeks of treatment
Secondary outcomes (27)
The time of the first acute exacerbation
The time of the patients' first acute exacerbation will be recorded.
Measured: Up to week 52.
Frequency of acute exacerbation
Frequency of acute exacerbation will be recorded.
Measured: Up to week 52
Frequency of acute exacerbations resulting in hospitalization
Frequency of acute exacerbation resulting in hospitalization will be recorded.
Measured: Up to week 52
Frequency of acute exacerbations resulting in ICU admission
Frequency of acute exacerbation resulting in ICU admission will be recorded.
Measured: Up to week 52
Annual acute exacerbation rate
The annual acute exacerbation rate will be calculated in each group at the end of the trial.
Measured: Up to week 52
Annual hospitalization rate due to acute exacerbation
The Annual hospitalization rate due to acute exacerbation will be calculated in each group at the end of the trial.
Measured: Up to week 52
Annual rate of ICU admission due to acute exacerbation
The Annual ICU admission rate due to acute exacerbation will be calculated in each group at the end of the trial.
Measured: Up to week 52.
Diffusing Capacity of Carbon Monoxide（DLCO）
DLCO will be used to assess pulmonary function.
Measured: Change from baseline DLCO at week 13, 26, 39 and 52.
Percent of Diffusing Capacity of Carbon Monoxide（DLCO%）
DLCO% will be used to assess pulmonary function.
Measured: Change from baseline DLCO% at week 13, 26, 39 and 52.
Percent of Forced Vital Capacity（FVC%）
FVC% will be used to assess pulmonary function.
Measured: Change from baseline FVC%at week 13, 26, 39 and 52.
Alveolar ventilation（VA）
VA will be used to assess pulmonary function.
Measured: Change from baseline VA at week 13, 26, 39 and 52.
.Diffusion capacity for carbon monoxide per liter of alveolar volume（DLCO/VA）
DLCO/VA will be used to assess pulmonary function.
Measured: Change from baseline DLCO/VA at week 13, 26, 39 and 52.
All-cause mortality rate
The all-cause mortality rate will be calculated in each group at the end of the trial.
Measured: Up to week 52.
Mortality rate due to acute exacerbation
The mortality rate due to acute exacerbation will be calculated in each group at the end of the trial.
Measured: Up to week 52.
Progression-Free Survival（PFS）
According to "Idiopathic Pulmonary Fibrosis in Adults (Update) and Progressive Pulmonary Fibrosis: An Official Clinical Practice Guideline of the ATS/ERS/JRS/ALAT ": The time from enrollment to the first meeting of disease progression (at least two of respiratory symptoms, physiological evidence and radiological evidence).
Measured: Up to week 13, 26, 39 and 52.
Six Minute Walk Test (6MWT)
6MWT will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
Measured: Change from baseline 6MWT at week 13, 26, 39 and 52.
Imaging findings
Changes in chest CT imaging will be assessed before and after JSHX treatment to evaluate its impact on pulmonary fibrosis in IPF patients. High-resolution computed tomography (HRCT) will be used to quantify alterations in lung parenchyma, including ground-glass opacities, reticulation, and honeycombing. Quantitative software-based analysis (e.g., histogram-based texture analysis) may be applied to standardize the evaluation. Radiologists blinded to treatment allocation will independently review the images to ensure objectivity.
Measured: Up to week 26, 52.
A Tool to Assess Quality of life (ATAQ-IPF)
ATAQ - IPF is currently a specialized scale for evaluating the quality of life of patients, consisting of 13 dimensions and 74 items, with each item being scored from 1 to 5 points. A higher score indicates a worse condition.
Measured: Change from baseline ATAQ-IPF scores at week 13, 26, 39 and 52.
Idiopathic pulmonary fibrosis patient reported outcomes (IPF-PRO)
IPF-PRO is a scale used to evaluate the quality of life of patients, where patients recall their condition over the past two weeks based on their subjective experience. The evaluation covers four domains: Physiological, Psychological, Environmental, and Satisfaction, comprising 18 items in total. Higher scores indicate worse conditions.
Measured: Change from baseline SGRQ scores at week 13, 26, 39 and 52.
Dyspnea
Dyspnea will be assessed by 22.modified Medical Research Council(mMRC) scores. A score of 0-4 will be given according to the degree of immediate dyspnea. A higher score indicates a worse condition.
Measured: Change from baseline CAT scores at week 13, 26, 39 and 52.
Cough Visual analog scale(VAS)
The Cough VAS is a method of quantitatively assessing cough symptoms using the Visual Analogue Scale. The score ranges from 1 to 100, a higher score indicates a worse condition.
Measured: Change from baseline CAT scores at week 13, 26, 39 and 52.
Clinical symptoms and Signs
Clinical symptoms and Signs will be evaluated through a scale. The scale includes coughing, expectoration, chest tightness, shortness of breath, wheezin. The Clinical Symptom Rating Scale includes 6 items: cough, expectoration, chest tightness, shortness of breath, wheezing, and cyanosis. Each item has a score of 0-3, totaling 18 points. The higher the score, the worse he patient's condition.
Measured: Change from baseline clinical symptoms and signs up at week 13, 26, 39 and 52.
Krebs Von den Lungen-6 (KL-6)
Detect the level of KL-6.
Measured: Change from baseline KL-6 level at week 13, 26, 39 and 52.
Interleukin-6 (IL-6)
Detect the level of IL-6.
Measured: Change from baseline IL-6 level at week 13, 26, 39 and 52.
Ferritin
Detect the level of Ferritin.
Measured: Change from baseline Ferritin level at week 13, 26, 39 and 52.
Immunoglobulin
Detect the level of immunoglobulins
Measured: Change from baseline immunoglobulins level at week 13, 26, 39 and 52.
T, B and NK lymphocyte subsets
Detect the level of T, B and NK lymphocyte subsets. The common indicators of TBNK lymphocyte subsets and their respective units of measurement are as follows: the total T cells (CD3+), measured in cells per microliter (cells/µL); the helper T cells (CD3+CD4+), measured in cells/µL; the cytotoxic T cells (CD3+CD8+), measured in cells/µL; the B cells (CD19+), measured in cells/µL; the natural killer cells (NK cells, CD16+CD56+, CD3-), measured in cells/µL; and the CD4/CD8 ratio, which is a unitless ratio. These indicators are detected by flow cytometry and can reflect the immune function status of the body.
Measured: Change from baseline T, B and NK lymphocyte subsets level 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 posted6 Apr 2025
- Study start8 Sep 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis(IPF)Studies 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
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914713
- Sponsor's protocol ID
- CM for IPF
- Status last verified
- Oct 2026
- First submitted
- 31 Mar 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Jin-shui Huan-xian Formula in Retarding the Decline of Pulmonary Function in IPF
- ClinicalTrials.gov ID
- NCT06914713
- Acronym / sponsor ID
- CM for IPF
- Conditions
- Idiopathic Pulmonary Fibrosis(IPF)
- Keywords
- Idiopathic Pulmonary Fibrosis, traditional Chinese medicine, randomized controlled trial, pulmonary function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 6 Apr 2025 (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 clinical efficacy and safety of Jin-shui Huan-xian Formula in retarding the decline of pulmonary function in IPF, generate high - quality clinical evidence, and establish a treatment plan of Jin-shui Huan-xian Formula for retarding the decline of pulmonary function in Idiopathic Pulmonary Fibrosis（IPF）
Detailed description
This study will enroll 384 patients with idiopathic pulmonary fibrosis (IPF) and adopts a randomized, quadruple-masked, placebo-controlled trial design. Participants will be randomly assigned to either an experimental group or a control group. On the basis of guideline-directed standard treatment, the experimental group will receive Jin-shui Huan-xian Formula, while the control group will receive a matching placebo. Participants, care providers, investigators, and outcome assessors will remain blinded to treatment allocation. The treatment duration is 52 weeks. Forced vital capacity (FVC) is the primary outcome measure, while acute exacerbations, other pulmonary function parameters (including DLCO and DLCO%), exercise capacity, and quality of life are secondary outcome measures. Safety assessments include routine blood tests, urinalysis, liver function, renal function, and electrocardiography. The study aims to evaluate the efficacy and safety of Jin-shui Huan-xian Formula in slowing the decline in pulmonary function in patients with IPF and to generate high-quality clinical evidence for its use as an adjunctive treatment.
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 in addition to the guideline - directed treatment. | Experimental | Drug: Jin-shui Huan-xian granuleThe experimental group was given Jin-shui Huan-xian Formula in addition to the treatment guided by the guideline "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline ". |
| Jin-shui Huan-xian granule placebo in addition to the guideline - directed treatment. | Placebo comparator | Drug: Jin-shui Huan-xian granule placeboParticipants in the control group will receive Jin-shui Huan-xian granule placebo in addition to guideline-directed treatment based on the "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who meet the diagnostic criteria for IPF.
- Pulmonary function: The percentage of forced vital capacity (FVC) to the predicted value is ≥ 50%; and the percentage of the diffusing capacity of the lung for carbon monoxide (DLCO) to the predicted value is ≥ 30%.
- Patients who meet the syndrome - differentiation criteria for lung - qi deficiency syndrome, lung - and - kidney qi deficiency syndrome, etc.
- Aged between 40 and 85 years old.
- Patients who voluntarily accept the treatment and sign the informed consent
Key exclusion criteria (9 listed)
- Patients in the acute exacerbation phase of IPF.
- Patients complicated with other pulmonary diseases such as chronic obstructive pulmonary disease (COPD), lung cancer, active pulmonary tuberculosis, bronchiectasis, and pulmonary embolism.
- Patients with severe joint, peripheral nerve, and peripheral vascular diseases that affect limb movement and who are bed - ridden for a long time and cannot complete the six - minute walk test.
- Patients complicated with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, heart function grade 3 or above, stroke, cerebral hemorrhage, etc.).
- Patients complicated with liver diseases such as cirrhosis or secondary portal hypertension, bleeding caused by esophageal and gastric varices, patients with kidney diseases requiring dialysis or kidney transplantation, or patients with abnormal liver and kidney functions (ALT, AST, and BUN are 1.5 times higher than the upper limit of the normal range, and blood Cr is higher than the upper limit of the normal range).
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 granuleAlso: Jin-shui Huan-xian GranulesJin-shui Huan-xian Granules: on the basis of treatment guided by "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline ", the experimental group was given Jin-shui Huan-xian Granules for treatment. The granules were taken orally, 1 dose per day, twice a day, and the continuous administration lasted for 52 weeks. | Drug | Jin-shui Huan-xian granule in addition to the guideline - directed treatment. |
| Jin-shui Huan-xian granule placeboJin-shui Huan-xian granule placebo: on the basis of treatment guided by "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline ", the experimental group was given Jin-shui Huan-xian Granules placebo for treatment. The granules were taken orally, 1 dose per day, twice a day, and the continuous administration lasted for 52 weeks.The Jin-shui Huan-xian granules and their placebo are identical in appearance, weight, color and smell. | Drug | Jin-shui Huan-xian granule placebo in addition to the guideline - directed treatment. |
Primary outcome
Forced vital capacity (FVC)
Time frame: The change in absolute FVC value before treatment and at 52 weeks of treatment
FVC will be used to assess pulmonary function.
27 secondary outcomes
The time of the first acute exacerbation
Time frame: Up to week 52.
Frequency of acute exacerbation
Time frame: Up to week 52
Frequency of acute exacerbations resulting in hospitalization
Time frame: Up to week 52
Frequency of acute exacerbations resulting in ICU admission
Time frame: Up to week 52
Annual acute exacerbation rate
Time frame: Up to week 52
Annual hospitalization rate due to acute exacerbation
Time frame: Up to week 52
Annual rate of ICU admission due to acute exacerbation
Time frame: Up to week 52.
Diffusing Capacity of Carbon Monoxide（DLCO）
Time frame: Change from baseline DLCO at week 13, 26, 39 and 52.
Percent of Diffusing Capacity of Carbon Monoxide（DLCO%）
Time frame: Change from baseline DLCO% at week 13, 26, 39 and 52.
Percent of Forced Vital Capacity（FVC%）
Time frame: Change from baseline FVC%at week 13, 26, 39 and 52.
Alveolar ventilation（VA）
Time frame: Change from baseline VA at week 13, 26, 39 and 52.
.Diffusion capacity for carbon monoxide per liter of alveolar volume（DLCO/VA）
Time frame: Change from baseline DLCO/VA at week 13, 26, 39 and 52.
All-cause mortality rate
Time frame: Up to week 52.
Mortality rate due to acute exacerbation
Time frame: Up to week 52.
Progression-Free Survival（PFS）
Time frame: Up to week 13, 26, 39 and 52.
Six Minute Walk Test (6MWT)
Time frame: Change from baseline 6MWT at week 13, 26, 39 and 52.
Imaging findings
Time frame: Up to week 26, 52.
A Tool to Assess Quality of life (ATAQ-IPF)
Time frame: Change from baseline ATAQ-IPF scores at week 13, 26, 39 and 52.
Idiopathic pulmonary fibrosis patient reported outcomes (IPF-PRO)
Time frame: Change from baseline SGRQ scores at week 13, 26, 39 and 52.
Dyspnea
Time frame: Change from baseline CAT scores at week 13, 26, 39 and 52.
Cough Visual analog scale(VAS)
Time frame: Change from baseline CAT scores at week 13, 26, 39 and 52.
Clinical symptoms and Signs
Time frame: Change from baseline clinical symptoms and signs up at week 13, 26, 39 and 52.
Krebs Von den Lungen-6 (KL-6)
Time frame: Change from baseline KL-6 level at week 13, 26, 39 and 52.
Interleukin-6 (IL-6)
Time frame: Change from baseline IL-6 level at week 13, 26, 39 and 52.
Ferritin
Time frame: Change from baseline Ferritin level at week 13, 26, 39 and 52.
Immunoglobulin
Time frame: Change from baseline immunoglobulins level at week 13, 26, 39 and 52.
T, B and NK lymphocyte subsets
Time frame: Change from baseline T, B and NK lymphocyte subsets level at week 13, 26, 39 and 52.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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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.
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(IPF), 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming-Hang Wang, Ph.D (+8618638392188, wmh107hn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced vital capacity (FVC) (time frame: The change in absolute FVC value before treatment and at 52 weeks of treatment). 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 16 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.