Skip to content

A phase II clinical trial of Lianju capsule

Efficacy and safety of Lianju capsule for treating the common cold with wind-heat syndrome: a randomized, double-blind, placebo-controlled, multi-center, phase II clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006504
Enrollment
Unknown
Registered
2015-06-04
Start date
2016-05-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Common cold

Interventions

High-dose group:4 Lianju Granules each time, 3 times per day
Medium-dose group:2 Lianju Granules plus 2 placebo each time, 3 times per day
Low-dose group:1 Lianju Granule plus 3 placebo each time, 3 times per day
Placebo control group:4 placebo each time, 3 times per day

Sponsors

West China Hospital of 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 TCM; 3. Aged between 18 and 65 years; 4. Presenting within 36 hours after symptom onset; 5. Willing to participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with acute herpetic pharyngitis,acute viral pharyngitis,acute herpetic laryngitis,acute viral laryngitis,acute conjunctivitis or acute tonsillitis, pneumonia and other diseases; 2. Patients with severe primary diseases of cardiovascular,lung,kidney and hematopoietic system or abnormal ECG with clinical significance; 3. Patients with liver function levels (such as ALT and AST) 1.5 times higher than the upper limit of normal,abnormal serum creatinine,positive urine protein qualitative test, white blood cell count>3.0*10^9/L or>10.0*10^9/L, and/or neutrophil percentage>80%; 4. Patients who had used other drugs after the onset of the disease(including cold medicines, antibiotics,antivirals and similar medicine); 5. The temperature >=39.0 degree C; 6. Pregnant or preparing to pregnancy, breast feeding women; 7. Allergy body or be allergy to the drug composition(s); 8. Patients with mental or legal disabilities; 9. Patients who participated in clinical trials of other drugs within the past 3 months; 10. Subjects who are not suitable for the trial decided by the researchers for any reason.

Design outcomes

Primary

MeasureTime frame
Disappearing time of all symptoms;

Secondary

MeasureTime frame
Disappearing time of each symptom;Time to fever clearance;Time to fever clearance;Disappearing rate of major symptoms;Relief of major symptom of TCM;Relief of symptom of TCM;Each symptom score of TCM;

Countries

China

Contacts

Public ContactMao bing
maobing@medmail.com.cn+86 18980601724

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 27, 2026