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Chinese herbal medicine Shufeng Jiedu capsule for patients with mild to moderate COVID-19

Not Applicable
Completed
Conditions
COVID-19 (SARS-CoV-2 infection)
Infections and Infestations
Registration Number
ISRCTN14236594
Lead Sponsor
Department of Science and Technology of Anhui Province
Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38863976/ (added 25/06/2024)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
407
Inclusion Criteria

1. Meet the mild and common diagnostic criteria for COVID-19;
2. The time interval between symptom onset and random enrollment was less than 3 days;
3. Adults (=18 and =75 years);
4. Agree to participate in this study and accept random grouping;
5. Those who have signed informed consent and are not currently participating in other clinical trials of traditional Chinese medicine for COVID-19

Exclusion Criteria

1 Female patients in pregnancy and lactation;
2 Patients with a history of allergy to the test drug ingredients;
3. As judged by the investigator, or patients with acute episodes, cognitive insufficiency, or severe diarrhea (resulting in electrolyte disturbances and dehydration);
4. Continuous use of traditional Chinese medicine (tripartite and three-drug treatment) for COVID-19 within 3 days before enrollment;
5. Patients who are also participating in other clinical trials.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Time to alleviation of symptoms (TTAS). Clinical symptoms are based on flu-like associated symptoms, including cough, stuffy nose, sore throat, fever or chills, muscle/joint pain, headache, and fatigue measured using self-report on a 0-3 scale (0 as no symptoms, 1 as mild symptoms, 2 as moderate symptoms and 3 as severe symptoms) at baseline, every day during the intervention (from 1st-6th day), and every day during follow-up (since discharged from hospital until 14th day).
Secondary Outcome Measures
NameTimeMethod
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