Evidence-Based Complementary and Alternative Medicine / 2012 / Article / Tab 1

Research Article

Treatment of Common Cold Patients with the Shi-Cha Capsule: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Trial

Table 1

Inclusion and exclusion 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

(1) Patient has suffered from acute viral pharyngitis or laryngitis, acute herpetic pharyngitis or laryngitis, acute conjunctivitis, as well as acute tonsillitis, and so forth
(2) Patient has taken any medication for relief of symptoms prior to study initiation
(3) Patient who has fever (>38.5°C)
(4) Patient who is on analgesic or anti-inflammatory regimen requiring treatment with analgesics, nonsteroidal 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

TCM: traditional Chinese medicine.