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A multicenter, randomized, double-blind, placebo parallel controlled clinical study of the efficacy and safety of TCM acupoint application in COVID-19 (mild, common type) in adult patients with fever

A multicenter, randomized, double-blind, placebo parallel controlled clinical study of the efficacy and safety of TCM acupoint application in COVID-19 (mild, common type) in adult patients with fever

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067178
Enrollment
Unknown
Registered
2022-12-28
Start date
2022-12-28
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 (mild, common type) in adults with fever

Interventions

Treatment group:Traditional Chinese medicine acupoint application+Fuzheng Jiebiao formula
Control group:Traditional Chinese medicine acupoint application placebo+Fuzheng Jiebiao formula

Sponsors

Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Meet the diagnostic criteria for COVID-19; Clinical classification is light, ordinary type; The first onset of symptoms (or confirmed disease) to the random medication is not more than 48h, and the treatment has not been conducted; Body temperature: 37.3?; Age: 18-65 years old, gender is unlimited; They voluntarily participate in this clinical trial, gave informed consent and signed the informed consent form.

Exclusion criteria

Exclusion criteria: Bacteria, fungi and other infections other than novel coronavirus infection; Combined with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic and endocrine system or immune system diseases (the upper limit of liver function ALT and AST> normal reference value, the upper limit of Scr> normal reference value, poor blood glucose control); Mental retardation, mental disorders; Planned pregnancy, pregnancy, lactation women and during the trial; Allergy constitution or allergy to the drug ingredients and excipients of this test; Participated in other clinical trials in the recent 1 month; The Investigator does not considered appropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Complete antipyretic time (hours);

Secondary

MeasureTime frame
Onset time of antipyretic effect (hours);Utilization rate and per capita dose of emergency antipyretic drugs (acetaminophen);Change from baseline in individual symptom scores on days 4 and 6 after treatment;

Countries

China

Contacts

Public ContactQi wen sheng

Guang 'anmen Hospital, China Academy of Chinese Medical Sciences

qwsqws@sohu.com13671039118

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026