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The efficacy and safety of Tanreqing oral liquid for treating common cold with wind-heat syndrome: a multicenter, phase III, parallel-group, double-blind, single-dummy, randomized, placebo controlled trial

The efficacy and safety of Tanreqing oral liquid for treating common cold with wind-heat syndrome: a multicenter, phase III, parallel-group, double-blind, single-dummy, randomized, placebo controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022951
Enrollment
Unknown
Registered
2019-05-04
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-05-05

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

Conditions

Common cold with wind-heat syndrome

Interventions

Experimental Group:Tanreqing oral liquid
Control Group:Dummy Tanreqing oral liquid

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of common cold according to western medicine; 2. Diagnosis of common cold with wind-heat syndrome according to Traditional Chinese Medicine; 3. Aged between 18 and 65 years old; 4. Within 36 hours after onset of common cold-like symptoms; 5. Be able to understand and sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with acute herpetic pharyngitis, acute viral pharyngitis, acute herpetic laryngitis, acute viral laryngitis, acute conjunctivitis, acute tonsillitis, pneumonia or Chest X-ray showing pulmonary inflammation; 2. Patients with severe cardio-cerebrovascular, lung, kidney or hematopoietic system diseases; 3. Patient's body temperature over 38.5 degree; 4. ALT or AST 1.5 times over the upper limit of normal reference values; abnormal blood creatinine; urine protein>+; blood WBC 10.0×10^9/L and/or neutrophil differential count >80%; 5. Other medicines (including cold, antibiotics, antivirals and similar traditional Chinese medicines) that have been used to treat the disease since the onset of the disease; 6. Pregnant and lactating women, and those with pregnancy plans for the next three months; 7. Allergic constitution or allergic to this medicine; 8. Patients with serious diseases (such as tumors) affecting their survival, as well as psychiatric patients; 9. Patients who have participated in other drug clinical trials within one month or are participating in other drug clinical trials; 10. Patients considered unsuitable for inclusion by researchers.

Design outcomes

Primary

MeasureTime frame
Duration of all symptom;

Secondary

MeasureTime frame
Rate of symptom resolution;Single symptom duration and resolution rate;Antipyretic time;Body temperature recovery time and rate;Changes of TCM symptom score;

Countries

China

Contacts

Public ContactBing Mao

West China Hospital, Sichuan University

maobing@medmail.com.cn+86 18980601724

Outcome results

None listed

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