Treatment of Pulmonary Fibrosis Due to COVID-19 With Fuzheng Huayu

NCT04279197 | Completed Phase 2

• 1 other identifier: Fzhy-ncp-2
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

According to previous studies, viral pneumonia can develop into pulmonary fibrosis, which can affect patients'lung function and even life health.This study aims to observe the efficacy and safety of Fuzheng Huayu Tablets in the treatment of pulmonary fibrosis after COVID-19.

Conditions

Pulmonary Fibrosis Due to COVID-19

Outcome Measures

Primary Outcomes (2)

• The improvement proportion of pulmonary fibrosis

  Evaluation of pulmonary fibrosis Improvement. pulmonary fibrosis judged by HRCT score.HRCT images are divided into four grades according to the score, and a reduction of one grade is an improvement.

  Week 24

• The improvement of lung function

  FVC, FEV1, FVC/FEV1

  Week 24

Secondary Outcomes (6)

• The improvement proportion of pulmonary inflammation

  Week 24

• The improvement proportion of clinical symptom

  Week 24

• Quality of Life-BREF (QOL-BREF)

  Week 24

• Patient Health Questionnaire-9(PHQ-9)

  Week 24

• Generalized anxiety disorder-7(GAD-7)

  Week 24

Study Arms (2)

FZHY Group

EXPERIMENTAL

usual treatment (respiratory function rehabilitation training + Vitamin C tablets) * Fuzheng Huayu tablets

Drug: Fuzheng Huayu Tablet; Drug: Vitamin C tablets; Other: respiratory function rehabilitation training

Placebo Group

PLACEBO COMPARATOR

usual treatment (respiratory function rehabilitation training + Vitamin C tablets) * placebo

Drug: Vitamin C tablets; Drug: Placebo; Other: respiratory function rehabilitation training

Interventions

Fuzheng Huayu Tablet DRUG

FZHY, administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal.

Also known as: FZHY

FZHY Group

Vitamin C tablets DRUG

Vitamin C tablets, administration: 0.2g/time, 3 times/ day, oral；

Also known as: VC

FZHY Group; Placebo Group

Placebo DRUG

Placebo , administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal.

Placebo Group

respiratory function rehabilitation training OTHER

Health exercise, once a day

FZHY Group; Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients who have undergone lung surgery that affects pulmonary function, such as pulmonary transplantation, pulmonary resection, pulmonary volume reduction, etc;
• Relying on mechanical ventilation to maintain pulmonary function, such as ventilators;
• Combined with chronic pulmonary diseases affecting pulmonary function, such as chronic obstructive pulmonary disease, other known causes of interstitial pulmonary disease;
• Patients with diseases affecting cardiac function, such as pulmonary circulation hypertension, heart failure, peripheral vascular disease, fibromyalgia, and pacemaker installation;
• Patients with severe underlying diseases affecting survival, including uncontroled cardiac, renal, digestive, hematological, neuropsychiatric, immune, metabolic diseases, malignant diseases and severe malnutrition;
• Resting heart rate \>120 times/min;
• Systolic blood pressure \> 180 mmHg, diastolic blood pressure \> 100 mmHg;
• Unstable angina pectoris or myocardial infarction occurring within the last month;
• Severe obesity (BMI \> 30 kg/m2);
• Allergic constitution, allergic to the drug components involved in the treatment program;
• Pregnant or breastfeeding women;
• Patients with disabilities who are unable to complete the efficacy evaluation questionnaires;
• Difficult collaborators with poor mental health status, suffering from mental illness, patients without self-control, unable to express clearly;
• Those who are participating in other clinical trials;
• According to the investigator's judgment, patients whose enrollment complications or poor compliance will affect the efficacy and safety evaluation.

Sponsors & Collaborators

• ShuGuang Hospital: lead
• Hubei Hospital of Traditional Chinese Medicine: collaborator
• Jingmen No.1 People's Hospital: collaborator
• Wuhan No.1 Hospital: collaborator
• Wuhan Third Hospital: collaborator
• Huangshi Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Shuguang Hospital

Shanghai, Shanghai Municipality, 201203, China

Location

Related Publications (1)

• Jing F, Wang W, Ke J, Huang T, Jiang B, Qiu Q, Huang J, Zhan S, Zhang W, Wu H, Su W, Feng J, Peng Y, Zhao Z, Xing F, Liu C. Fuzheng Huayu tablets for treating pulmonary fibrosis in post-COVID-19 patients: a multicenter, randomized, double-blind, placebo-controlled trial. Front Pharmacol. 2025 Mar 11;16:1508276. doi: 10.3389/fphar.2025.1508276. eCollection 2025.

  PMID: 40135237 DERIVED

MeSH Terms

Interventions

fuzheng huayu; Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Chenghai Liu

  Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institute Director

Study Record Dates

• First Submitted: February 15, 2020
• First Posted: February 21, 2020
• Study Start: April 23, 2020
• Primary Completion: March 24, 2021
• Study Completion: March 24, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)