FindTrial
Sign In

Rheum and Pharyngitis Oral Solution for mild COVID-19 patients with the syndrome of damp-heat accumulation in the lung pattern: A randomized, double-blind, double-dummy, positive drug parallel controlled study

Rheum and Pharyngitis Oral Solution for mild COVID-19 patients with the syndrome of damp-heat accumulation in the lung pattern: A randomized, double-blind, double-dummy, positive drug parallel controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005905
Enrollment
Unknown
Registered
2022-04-25
Start date
2022-04-11
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

COVID-19

Interventions

control group:Rheum and Pharyngitis Oral Solution Placebo+Lianhua Qingwen Capsule
experimental group:Rheum and Pharyngitis Oral Solution+Lianhua Qingwen Capsule Placebo

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ?Patients who meet the diagnostic criteria of mild COVID-19; ?Patients who meet the TCM syndrome of damp-heat accumulation in the lung pattern;?The clinical manifestations are at least one of the four main symptoms including fever, sore throat, cough and fatigue;?Since the onset of COVID-19, the axillary temperature of the patient is = 38.5 ?; ?Patients who are aged 18–75 years; ?Patients who sign the written informed consent form.

Exclusion criteria

Exclusion criteria: ?Patients with COPD,asthma,bronchiectasis,active pulmonary tuberculosis,lung malignant tumors or Interstitial lung disease;?Patients with severe cardiovascular, cerebrovascular,severe diseases of hematopoietic systemliver,malignant tumors or those Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or serum creatinine (Scr) exceed 1.5 times the upper limit of normal value; ?Patients who are unwilling to cooperate or unable to cooperate due to neurological and mental diseases;?Patients with history of allergies or hypersensitivity for any research drug component;?Patients with peptic ulcer or digestive hemorrhage;?Pregnant or lactating women, or those planning pregnancy;?Patients who have received any experimental drug treatment within 3 months;?Patients considered unsuitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
The cure rate of symptoms including sore throat, fever, cough and fatigue;—

Secondary

MeasureTime frame
The disappearance time of single symptom including sore throat, fever, cough and fatigue;The change of cough severity VAS scores;The cure rate of different symptoms of sore throat, fever, cough and fatigue;The area under curve(AUC) of sore throat severity VAS scores;The negative rate of virus nucleic acid;The disappearance time of symptoms including sore throat, fever, cough and fatigue;The change of sore throat severity VAS scores;Incidence of common or severe novel coronavirus pneumonia;The re-positive rate of virus nucleic acid;The change of fatigue severity VAS scores;—

Countries

China

Contacts

Public ContactLin Lin
drlinlin620@163.com13903002015

Outcome results

None listed

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