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A Phase III, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TD0069 Capsule for Patients With Mild to Moderate COVID-19

NCT05249777 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 573

Last updated 2022-09-21

No results posted yet for this study

Summary

The acute pneumonia pandemic caused by a new strain of corona virus 2019, namely as COVID-19 by the World Health Organization (WHO), is a pandemic caused by SARS-CoV-2 virus. The reported symptoms vary from fever or chills, cough, shortness of breath, to muscle aches, headaches, loss of taste or smell.

The capsule TD0069 is a product based on the traditional medicine named "Ren shen bai du san" which is used to treat the cold conditions, also known as the initial plague according to the theory of traditional medicine.

Conditions

Interventions

DRUG

TD0069 hard capsule

TD0069 hard capsule (800 ± 7.5% mg/capsule) contains 600 mg fine powder of mixed herbal medicines and 200 mg excipients.

DRUG

TD0069 Placebo

TD0069 placebo (800 ± 7.5% mg/capsule) contains excipients

Sponsors & Collaborators

  • CLINICAL RESEARCH VIET NAM SKILL TRAINING AND CONSULTING COMPANY LIMITED

    collaborator UNKNOWN

  • Sao Thai Duong Joint Stock Company

    lead INDUSTRY

Principal Investigators

  • Loc Huynh Nguyen, SL II., MD. · Traditional Medicine Institute in Ho Chi Minh City

  • Lan Truong Thi Ngoc, PhD., MD. · Traditional Medicine Institute in Ho Chi Minh City

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-06
Primary Completion
2022-08-05
Completion
2022-09-10

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05249777 on ClinicalTrials.gov