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Treatment of common cold with wind-cold type patients with the Shi-cha capsule: amulti-center, double-blind, randomized, placebo-controlled, dose-escalation trial

Treatment of common cold with wind-cold type patients with the Shi-cha capsule: amulti-center, double-blind, randomized, placebo-controlled, dose-escalation trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002296
Enrollment
Unknown
Registered
2012-06-19
Start date
2010-11-13
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 with wind-cold type

Interventions

two group:low dose
three group:High dose

Sponsors

Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, West China School of Medicine, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. 18 to 65 years of age; 2. Diagnosis of common cold by a respiratory expert according to relevant criteria and the syndrome criteria of wind-cold type in TCM; 3. Patient within 48 hours of onset of common cold-like illness; 4. Patient must be able to understand and give written informed consent and report adverse events and concomitant medication for the duration of the study.

Exclusion criteria

Exclusion criteria: 1. Patient has suffered from acute viral pharyngitis or laryngitis, acute herpetic pharyngitis or laryngitis, acute conjunctivitis, as well as acute tonsillitis, etc.; 2. Patient has taken any medication for relief of symptoms prior to study initiation; 3. Patient who are fever (> 38.5 degree C); 4. Patient who are on analgesic or anti-inflammatory regimen requiring treatment with analgesics, non-steroidal anti-inflammatory drugs, or steroids; 5. Patient is pregnant, nursing, or a woman of childbearing potential not practicing adequate contraception. Women, who are uncertain if they are pregnant, may participate in the study, if they undergo a pregnancy test, which shows a negative result; 6. Patient has comorbid condition, uncontrolled metabolic condition or psychiatric condition that might make tolerance or evaluation of the symptoms difficult.

Design outcomes

Primary

MeasureTime frame
The primary end point was all symptom duration;

Secondary

MeasureTime frame
main symptom duration;minor symptom duration;

Countries

China

Contacts

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

Outcome results

None listed

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