The efficacy and safety of Ganduqing granule for treating common cold with qi deficiency leading to lingering of evil syndrome: a randomized, double-blind, placebo, parallel-group, multicenter- controlled trial
- Conditions
- Common Cold
- Registration Number
- ITMCTR1900002681
- Lead Sponsor
- Hospital of of Chengdu University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Meet the diagnosis of common cold according to Western medicine;
(2) Meet the diagnosis of common cold with qi deficiency syndrome according to Traditional Chinese Medicine;
(3) Repeated colds every year, more than 4 times;
(4) Symptom presenting within 48 hours;
(5) Aged between 18 and 70 years;
(6) Voluntarily participate and provide signed informed consent.
(1) Influenza;
(2) Patient's body temperature over 39 degree C;
(3) White blood cell count > 12.0 x 10^9/L and/or neutrophil percentage > 80%;
(4) Patients with other infectious diseases of the respiratory tract, such as acute herpetic pharyngitis, acute viral pharyngitis, acute herpetic laryngitis, acute viral laryngitis, acute tonsillitis, and pneumonia;
(5) Liver function levels (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)) 1.5 times higher than the upper limit of normal or abnormal serum creatinine;
(6) Allergic or possibility of being allergic to the ingredients in the study drug;
(7) Patients with severe cardio-cerebrovascular, lung, kidney or hematopoietic system diseases;
(8) Patients who have participated in other drug clinical trials within one month or are participating in other drug clinical trials;
(9) Other medicines (including cold, antibiotics, antivirals and similar traditional Chinese medicines) that have been used to treat the disease since symptom presenting within 48 hours;
(10) Pregnant and lactating women;
(11) Psychiatric patients;
(12) Identified by the investigator as inappropriate to participate in this study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of all symptoms to resolve or heal from treatment.;Single symptom duration;Improvement in primary symptoms;
- Secondary Outcome Measures
Name Time Method Improvement in secondary symptoms;Changes of TCM symptom score;