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The efficacy and safety of Baoji Tablets for treating common cold (summer-heat and dampness type): a multicenter, phase II, parallel-group, double-blind, double-dummy, randomized, placebo and positive controlled trial

The efficacy and safety of Baoji Tablets for treating common cold (summer-heat and dampness type): a multicenter, phase II, parallel-group, double-blind, double-dummy, randomized, placebo and positive controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003197
Enrollment
Unknown
Registered
2013-05-01
Start date
2013-06-01
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 (summer-heat and dampness type)

Interventions

Experimental Group:Baoji Tablets and Dummy Baoji Pills
Placebo-control Group:Dummy Baoji Tablets and Dummy Baoji Pills
Positive-control Group:Dummy Baoji Tablets and Baoji Pills

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of common cold according to western medicine; 2. Diagnosis of summer-heat and dampness type common cold according to Traditional Chinese Medicine; 3. Aged between 18 and 65 years old; 4. Within 48 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 or acute tonsillitis; 2. Patients with acute gastroenteritis; 3. Patients with serious primary diseases of heart, liver, kidney, blood system or endocrine system, as well as patients with acute lower respiratory diseases, tumor or Acquired Immune Deficiency Syndrome; 4. ALT 1.5 times 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%; stool routine check see WBC > 1/HP and/or pus cells and/or phagocytes; 5.Patient's body temperature >38.5 degree C; 6. Any medication used for relief of symptoms prior to study initiation; 7. Pregnancy or ready to pregnant women, lactating women; 8. Allergic constitution or allergic to this medicine; 9. Mental or legally disabled patients; 10.Participanting or participated in other drug clinical trials within 3 months.

Design outcomes

Primary

MeasureTime frame
Duration of all symptom;

Secondary

MeasureTime frame
Main symptom duration;Minor symptom duration;The change of main symptom score;The change of minor symptom score;

Countries

China

Contacts

Public ContactBing Mao
maobing@medmail.com.cn+86 18980601724

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 21, 2026