Effect of a Traditional Chinese Medicine Formulation on COVID-19 Infection

NCT ID: NCT05672498

Last Updated: 2023-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-05

Study Completion Date

2023-05-05

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TCM treatment

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

Group Type ACTIVE_COMPARATOR

Traditional Chinese Medicine Formulation

Intervention Type DRUG

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.

placebo treatment

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

Group Type PLACEBO_COMPARATOR

Placebo Treatment

Intervention Type OTHER

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.

Interventions

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Traditional Chinese Medicine Formulation

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.

Intervention Type DRUG

Placebo Treatment

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bingyin Shi

Role: STUDY_CHAIR

First Affilicated Hospital of Xian Jiaotong University

Locations

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First Affilicated Hospital of Xian Jiaotong University

Xi’an, Shanxi, China

Site Status

Countries

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China

Central Contacts

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Bingyin Shi

Role: CONTACT

0086-13700298366

Zixian Du, master

Role: CONTACT

0086-15117288251

Facility Contacts

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Zixian Du, master

Role: primary

0086-15117288251

Other Identifiers

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XJTU1AF2022LSK-436

Identifier Type: -

Identifier Source: org_study_id

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