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Effect of Traditional Chinese Medicine of Severe COVID-19

NCT ID: NCT06714032

Last Updated: 2024-12-03

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-29

Study Completion Date

2024-01-25

Brief Summary

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This study evaluated the effect of integrated traditional Chinese and Western medicine in the treatment of Severe COVID-19. The patients were randomly divided into experimental group and control group.

Detailed Description

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In this study, a multi center randomized controlled trial design was adopted, and the subjects were randomly divided into the experimental group and the control group. The control group was treated with western medicine conventional treatment plus traditional Chinese medicine decoction simulant, while the experimental group was treated with traditional Chinese medicine syndrome differentiation treatment decoction. The course of treatment was 14 days and the patients were followed up for 3 months. The clinical effect of integrated traditional Chinese and Western medicine treatment was evaluated from the aspects of 28 day mortality, 28 days without invasive mechanical ventilation, invasive mechanical ventilation rate, 28 days without ICU stay, clinical stability time, length of hospital stay, quality of life, SOFA score, etc., to clarify the clinical efficacy of integrated traditional Chinese and Western medicine treatment for Severe COVID-19 infection.

Conditions

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Severe COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TCM plus conventional drug

The experimental group will receive three type of TCM inaddition conventional drug

Group Type EXPERIMENTAL

TCM plus conventional drug

Intervention Type DRUG

All patients were treated according to international guidelines. The Experimental group will receive TCM according to the TCM syndrome.

TCM placebo plus conventional drug

The control group will receive three type of placebo TCM inaddition conventional drug

Group Type PLACEBO_COMPARATOR

TCM placebo plus conventional drug

Intervention Type DRUG

All patients were treated according to international guidelines. The control group will receive TCM placebo according to the TCM syndrome.

Interventions

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TCM plus conventional drug

All patients were treated according to international guidelines. The Experimental group will receive TCM according to the TCM syndrome.

Intervention Type DRUG

TCM placebo plus conventional drug

All patients were treated according to international guidelines. The control group will receive TCM placebo according to the TCM syndrome.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* accord with the diagnosis of severe/critical novel coronavirus infection;
* Age \> 18 years old;
* TCM syndrome differentiation diagnosis by the attending physician or above or two attending physicians for diagnosis and consensus;
* Sign the informed consent form.

Exclusion Criteria

* Pregnant and lactating women;
* Trauma, hematological malignancies, various solid tumors and obstetric complications;
* Dementia, various mental patients and those who are unwilling to cooperate;
* The patient is expected to die within the next 24 hours;
* Combined with neuromuscular diseases affecting respiratory and motor functions;
* people who have been bedridden for a long time for various reasons;
* Clinical trial participants who are taking part in other intervention measures;
* Those who are known to be allergic to the therapeutic drugs in this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, China

Site Status

Countries

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China

Other Identifiers

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TCM for Severe COVID-19

Identifier Type: -

Identifier Source: org_study_id