NCT05672498

Brief Summary

Traditional Chinese medicine (TCM) has been handed down for thousands of years. It has a long history in the treatment of virus infection and has a good effect on the upper respiratory tract infection. In recent years, the project applicant has been conducting research on the anti infection and anti inflammation treatment of traditional Chinese medicine, and has carried out a lot of clinical practice exploration in non-specific inflammation. The purpose of this research is to study the therapeutic effect of a traditional Chinese medicine prescription on COVID-19 infection.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 5, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2023

Completed
Last Updated

January 9, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

January 3, 2023

Last Update Submit

January 5, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

  • negative Covid-19 test result

    negative test result

    in 7 days or after the intervention

  • Disappearance or Improvement of the most common clinical symptoms

    such as fever,cough,pharyngalgia

    in 7 days or after the intervention

Secondary Outcomes (6)

  • erythrocyte sedimentation rate

    in 7 days or after the intervention

  • C-reactionprotein

    in 7 days or after the intervention

  • Interleukin- 6

    in 7 days or after the intervention

  • Procalcitonin

    in 7 days or after the intervention

  • Covid-19 antibody concentration

    in 7 days or after the intervention

  • +1 more secondary outcomes

Study Arms (2)

TCM treatment

ACTIVE COMPARATOR

The patients are treated with traditional Chinese medicine. They take 150ml of liquid medicine every morning and evening for 7 days.

Drug: Traditional Chinese Medicine Formulation

placebo treatment

PLACEBO COMPARATOR

The patients are treated with placebo. They take 150ml of liquid placebo every morning and evening for 7 days .

Other: Placebo Treatment

Interventions

Traditional Chinese Medicine FormulationDRUG

The TCM Treatment Group：The patient are given a traditional Chinese medicine formulation, taking 150 ml of liquid medicine every morning and evening for 7 days.

TCM treatment
Placebo TreatmentOTHER

Placebo Treatment Group:The patient are given placebo, taking 150 ml of liquid placebo every morning and evening for 7 days. All medications and placebo are packed identically in packing bags with the same labeling form.

placebo treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In the past two to three days, COVID-19 test was positive, accompanied by more than one clinical symptom.
  • ≤ age ≤ 65, regardless of gender;
  • Patients have good follow-up compliance.

You may not qualify if:

  • Human immunodeficiency virus - 1 infection and malignant tumors; Active cardiovascular, kidney, lung, liver, blood, digestive, neurological or psychiatric diseases; Recent acute respiratory symptoms (within 4 weeks) .
  • Any drug that may interfere with the evaluation (for example, other herbal products such as Lianhua Qingwen, immunosuppressants, anticoagulants), or a history of allergy or other adverse reactions to traditional Chinese medicine products.
  • Pregnant or lactating women.
  • Allergic constitution and allergy to multiple drugs.
  • According to the judgment of the investigator, the subject suffers from any disease that may endanger his safety or affect his compliance with the protocol, or other conditions that are not suitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affilicated Hospital of Xian Jiaotong University

Xi’an, Shanxi, 710061, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Bingyin Shi

    First Affilicated Hospital of Xian Jiaotong University

    STUDY CHAIR

Central Study Contacts

Bingyin Shi

CONTACT

0086-13700298366shibingy@126.com

Zixian Du, master

CONTACT

0086-15117288251379880218@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 5, 2023

Study Start

January 5, 2023

Primary Completion

April 5, 2023

Study Completion

May 5, 2023

Last Updated

January 9, 2023

Record last verified: 2023-01

Locations

CN(1)