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

ABSTRACT

ConditionCOVID-19 (SARS-CoV-2 infection)
Infections and Infestations

Intervention
Experimental group Shufeng Jiedu Capsule, taken orally for 5 days.
Control group Shufeng Jiedu placebo, taken orally for 5 days.
After 5 days of treatment, all participants are no longer taking any Traditional Chinese medicine. Participants were followed up for 14 days after discharge.
Participants are randomly allocated to groups using the coded boxes of pills.


Primary outcome: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).

CriteriaInclusion 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.