NCT04187690

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

Efficacy and Safety of Jin-shui Huan-xian Granule in the Treatment of IPF

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

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

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-05-31
• Completion: 2023-07-30
• First posted: 2019-12-05
• Last updated: 2022-08-18

Locations

1 site across 1 country: China