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Status unknownNCT04334265Updated Apr 24, 2020

Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019

An interventional study of Anluohuaxian in COVID-19, sponsored by Peking University First Hospital. Status unknown at 9 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-04-24.

Sponsored by Peking University First Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

To evaluate the efficacy and safety of Anluohuaxian in blocking the progression of pulmonary fibrosis and improving lung function in patients with COVID-19.

Read the detailed description

In clinical institutions that enroll patients with corona virus disease 2019, two arms, multi-center, randomized and controlled methods are adopted. Patients are divided into two groups, Anluohuaxian combined with regular treatment group and regular treatment group. 750 patients are expected to be enrolled and the cases are allocated according to the ratio of 2( Anluohuaxian combined with regular treatment group): 1(regular treatment group).

02

Conditions studied

  • COVID-19

Keywords

  • Anluohuaxian
03

In context

Virus Diseases

914 studies on the registry are indexed under Virus Diseases; 110 are open to participants now.

This study's planned enrollment of 750 is above the median of 102 across 604 interventional studies indexed under Virus Diseases.

Browse Virus Diseases studies →

Lead sponsor

Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Confirmed COVID-19, and the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs is negative twice after the treatment (sampling interval is at least 24 hours);
  2. Negative nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs during screening visits;
  3. High-resolution CT of the lung (HRCT) indicates pulmonary fibrosis (thickness of lobular septum, honeycomb-like changes, with or without bronchial / pleural distraction);
  4. Voluntarily participate in research and sign informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Combined with severe heart, lung (diagnosed with interstitial lung disease, bronchial asthma, chronic obstructive pulmonary disease, etc.), liver and kidney disease or with endocrine, rheumatic, neurologic, malignant and other systemic diseases;
  2. Have been diagnosed with connective tissue disease;
  3. Pregnant or lactating women;
  4. History of mental disorders, substance abuse or dependence;
  5. Have used other anti-pulmonary fibrosis drugs in the past 14 days, such as nidanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker, imatinib, glucocorticoid hormones, morphomycodyl esters, azathioprine, cyclophosphamide, interferon-γ, and traditional Chinese medicine;
  6. Researchers consider it inappropriate to participate in research;
  7. Participating in other clinical research.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
750 participants (estimated)

Study arms

  • Experimental
    Anluohuaxian combined with regular treatment group

    Anluohuaxian: 6g each time, twice a day

    Drug: Anluohuaxian

  • No intervention
    regular treatment group

Interventions

  • DrugAnluohuaxian

    6g each time, twice a day

06

What researchers measure

Primary outcomes

  1. Changes in high-resolution computer tomography of the lung

    Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography

    Time frame: 3 months

  2. Change in 6-minute walking distance

    Time frame: 3 months

Secondary outcomes

  1. Changes in compound physiological index

    Time frame: 3 months

  2. Changes in the scores of the St. George's Hospital Respiratory Questionnaire

    St. George's Hospital Respiratory Questionnaire range from 0 to 100. 0 stands for no impact on life and 100 stands for extreme impact on life.

    Time frame: 3 months

  3. Changes in modified British Medical Research Council Dyspnea Scale (mMRC) scores

    mMRC score range from 0 to 4. 0 stands for wheezing only when exercising hard and 4 stands for severe breathing difficulties.

    Time frame: 3 months

  4. Changes in vital capacity of the lung

    Adult male vital capacity is about 3,500 ml and female is about 2,500 ml.

    Time frame: 3 months

07

Study locations

1 of 9 sites recruiting
  • The Second People's Hospital of Fuyang
    Fuyang, Anhui 230022, China
    • Xianfeng Han · Contact · 13955881280
    Not yet recruiting
  • Ezhou Central Hospital
    Wuhan, Hubei 430000, China
    • Junhua Yu · Contact · 13908688619
    Not yet recruiting
  • Huoshenshan Hospital of Wuhan
    Wuhan, Hubei 430000, China
    • Sibin Zhang · Contact · 13911992121
    Not yet recruiting
  • Jinyintan Hospital of Wuhan
    Wuhan, Hubei 430000, China
    • Dingyu Zhang · Contact · 13507117929
    Recruiting
  • Tongji Hospital of Huazhong University of Science and Technology
    Wuhan, Hubei 430000, China
    • Qin Ning · Contact · 13971521450
    Not yet recruiting
  • West Hospital Union Hospital Huazhong University of Science and Technology
    Wuhan, Hubei 430000, China
    • Xi Zheng · Contact · 18602724981
    Not yet recruiting
  • Wuhan Pulmonary Hospital
    Wuhan, Hubei 430000, China
    • Xianxiang Chen · Contact · 18971570937
    Not yet recruiting
  • Zhongnan Hospital of Wuhan University
    Wuhan, Hubei 430000, China
    • Zhenshun Cheng · Contact · 13627288300
    Not yet recruiting
  • Wenzhou Medical University Affiliated First Hospital
    Wenzhou, Zhejiang 325000, China
    • Yongping Chen · Contact · 13505777281
    Not yet recruiting
08

References and documents

Publications

  • Zhang C, Li J, Wu Z, Wang H, Que C, Zhao H, Wang G. Efficacy and safety of Anluohuaxian in the treatment of patients with severe Coronavirus disease 2019- a multicenter, open label, randomized controlled study: a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 8;21(1):495. doi: 10.1186/s13063-020-04399-8. PubMed 32513299 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04334265
Lead sponsor
Peking University First Hospital
Responsible party
Guiqiang Wang (Principal Investigator, Peking University First Hospital) — Principal investigator
First posted
Apr 6, 2020
Start date
Apr 1, 2020
Primary completion
Jun 1, 2020 (estimated)
Completion
Dec 1, 2020 (estimated)
Last update
Apr 24, 2020

Study contacts

Guiqiang Wang
Contact
john131212@sina.com
13911405123
Hong Zhao
Contact
zhaohong_pufh@bjmu.edu.cn
13810765943
Guiqiang Wang
principal investigator · Peking University First Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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