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

NCT04187690 | Unknown DMC

• 1 other identifier: TCM for IPF
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; traditional Chinese medicine; randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• Frequencies of acute exacerbations (AEs)

  It will be assessed by frequencies of AEIPF-related hospitalizations.

  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.

  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.

  up to week 13, 26, 39 and 52.

Secondary Outcomes (8)

• Pulmonary function

  Change from baseline FVC and DLco% at week 26 and 52.

• All-cause mortality

  up to 52 weeks.

• Clinical symptoms and Signs

  Change from baseline clinical symptoms assessment questionnaire scores at week 13, 26, 39 and 52.

• Dyspnea

  Change from baseline mMRC scores at week 13, 26, 39 and 52.

• COPD assessment test (CAT)

  Change from baseline CAT scores at week 13, 26, 39 and 52.

Study Arms (2)

Jin-shui Huan-xian granule

EXPERIMENTAL

Participants in this arm will be given Jin-shui Huan-xian granule.

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.

Drug: Jin-shui Huan-xian granule placebo

Interventions

Jin-shui Huan-xian granule DRUG

Jin-shui Huan-xian granule will be administered 5days on and 2 days off for 52 weeks.

Jin-shui Huan-xian granule

Jin-shui Huan-xian granule placebo DRUG

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.

Jin-shui Huan-xian granule placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Study Sites (1)

the First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, 450000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 36056382 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jian-sheng Li, Professor

  The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Xue-qing Yu, PhD

CONTACT

86-371-66248624; yxqshi@163.com

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: December 3, 2019
• First Posted: December 5, 2019
• Study Start: September 1, 2020
• Primary Completion: May 31, 2023
• Study Completion: July 30, 2023
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

CN (1)