A randomized, controlled, parallel-group, double-blind study of the proprietary Kan Jang Oral Solution versus placebo in patients with non complicated respiratory tract infections (common cold).

Conditions: common cold

Registration Number: EUCTR2009-012640-17-FI

Lead Sponsor: Swedish Herbal Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Subjects in the age group of 18-65 years, of either sex.
•Subjects predominantly suffering from two or more symptoms of common cold (cough expectoration, running nose, headache, fever, sore throat, earache, malaise /fatigue and sleep disturbance) listed in Clinical Report Form (CRF) (Appendix 5).
•Subjects who have given written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•who were ill more than three days with a common cold
•with the fever higher than 38,5 °C.
•suffering from accompanying illnesses such as bronchiolitis, pneumonia, pleuritis, septic infections, special bacterial infections as pneumoconiosis, angina tonsilaris, sublingual fever higher than 40.5°C, sinusitis or any other infections.
•suffering from immunologically associated diseases such as multiple sclerosis, polyarthritis or rheumatic or other autoimmune diseases,
•with diabetes or with serious ailments of heart, liver, kidney or brain,
•suffering from any known abuse of medication, narcotics, tobacco (> 20 cigarettes/day) or alcohol.
•known allergies against cut flowers, herbal spices, or bitter seeds.
•being pregnant or breast-feeding, or is she trying to get pregnant?
•taking any kind of medication that can affect the course of an infection (anti-inflammatory medication, antihistamines, steroids, antibiotics).
•which at the first interview are judged to be not cooperative or not to be able to finalize the study,
•who were unable to give voluntary consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this clinical study is to assess the efficacy of Kan Jang Oral solution in non complicated respiratory tract infections (common cold) when it is used in the daily dose of 60 ml (30 ml two times per day). ;Secondary Objective: ;Primary end point(s): oDuration of clinical manifestations of the acute phase of disease <br>oRelief of clinical symptoms listed in clinical report form by a physician (Appendix 5).<br>oCough relief effect <br>

Secondary Outcome Measures