Jin-shui Huan-xian Granule in the Treatment of IPF

August 17, 2022 updated by: Henan University of Traditional Chinese Medicine

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xue-qing Yu, PhD
  • Phone Number: 86-371-66248624
  • Email: yxqshi@163.com

Study Locations

  • China
      • Zhengzhou, China, 450000
        • Recruiting
        • The First Affiliated Hospital of Henan University of Chinese Medicine
        • Contact:
          • Xue-qing Yu, Ph.D.
          • Phone Number: +8613525518843
          • Email: yxqshi@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jin-shui Huan-xian granule
Participants in this arm will be given Jin-shui Huan-xian granule.
Drug: Jin-shui Huan-xian granule
Jin-shui Huan-xian granule will be administered 5days on and 2 days off for 52 weeks.
Placebo Comparator: Jin-shui Huan-xian granule placebo
Participants in this arm will be given Jin-shui Huan-xian granule placebo.
Drug: Jin-shui Huan-xian granule placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequencies of acute exacerbations (AEs)
Time Frame: up to 52 weeks.
It will be assessed by frequencies of AEIPF-related hospitalizations.
up to 52 weeks.
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.
Change from baseline 6MWD at week 13, 26, 39 and 52
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.
up to week 13, 26, 39 and 52.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function
Time Frame: Change from baseline FVC and DLco% at week 26 and 52.
Forced vital capacity (FVC) and diffusing capacity percentage of the predicted value (DLco%) will be applied to assess pulmonary function.
Change from baseline FVC and DLco% at week 26 and 52.
All-cause mortality
Time Frame: up to 52 weeks.
The all-cause mortality will be calculated in each group at the end of the trial.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change from baseline ATAQ scores at week 13, 26, 39 and 52.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan University of Traditional Chinese Medicine

Investigators

  • Study Chair: Jian-sheng Li, Professor, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

July 30, 2023

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (Actual)

December 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCM for IPF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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