Trial of Chinese Herbal Medicine in the Treatment of Upper Respiratory Tract Infections (URTIs)

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Upper respiratory tract infections (URTIs) are the most common illnesses in primary medical services but there is no established cure for these conditions in Western medicine. In Hong Kong, many patients use Chinese herbal medicine (CHM) for the treatment of URTIs but there is little research evidence on their effectiveness or side effects. The aim of this study is to test whether two commonly used Chinese herbal medicine (CHM) formulae guided by Traditional Chinese medicine (TCM) diagnosis will significantly increase recovery rate, and reduce the duration and/or severity of symptoms, and improve the quality of life of patients with URTIs in primary care.

If a patient consents to take part in the study and is found eligible, he/she will be invited by the consulting doctor, and then be assessed by a registered Chinese medicine practitioner for whether the illness satisfies the TCM diagnosis of the two major TCM types of URTIs: Group A (Wind-cold syndrome) and Group B (Wind-heat syndrome). Subjects in Group A (Wind-cold syndrome) will be randomised to receive the Jing Fan Bai Du san or placebo. Subjects in Group B (Wind-heat syndrome) will be randomised to receive Ying Qiao san or placebo. Both group A and B treatments and placebo will be given in sachets of granules that are identical in appearance. Neither the Chinese medicine practitioner, the recruiting doctors, nor patient know whether a subject is taking CHM or placebo.

328 subjects (164 in each diagnosis group) will be recruited from patients consulting the Ap Lei Chau Government General Outpatient clinic for URTIs. Each subject is required to return to the clinic for follow-up assessment by the Chinese medicine practitioner on day 7 post-treatment and all subjects will be contacted by telephone on Day 2, 3, 5, 9, 11, 13,15 and 20 after treatment to assess their symptoms and to find out if they have developed any side effects or adverse reactions.

The main outcome measure is any difference in the proportion of subjects who have resolution of the URTI on Day 7 between the treatment and placebo groups. The secondary outcome measures are the reduction in the duration and severity of symptoms, quality of life during the illness and side effects.

This study will provide scientific evidence to support or refute the effectiveness of two commonly used CHM formulae in the treatment of URTIs.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Collaborator: The Research Fund for the Control of Infectious Diseases of the Food and Health Bureau, the Government of the Hong Kong SAR

Criteria

Inclusion Criteria:

• Patients will be included if they have all the following:

• Age ≥18 years old

• Patient has developed URTIs symptoms for 48 hours or less.

• At least one from each of the following groups of URTIs symptoms:

• Symptoms of infection: headache, chills, muscle ache, or an oral temperature greater than 37.5 degrees Celsius.

• Symptoms from the upper respiratory tract: cough, hoarseness, running nose, nasal obstruction, itchy throat, sore throat or sneezing.

Exclusion Criteria:

• Patients will be excluded from the study if they have one or more of the following:

• Have symptoms of URTIs for more than 48 hours.

• Pregnancy or breast-feeding

• Liver disease

• Known immune deficiency

• Alcohol (>30 units/wk) or drug abuse

• Medical history of asthma, allergic rhinitis, cystic fibrosis and chronic bronchopulmonary diseases

• Known allergies to food additives or study medications

• Taking chronic medications that contain any kind of herbs, mineral, or specific vitamin supplements

• Diabetes mellitus

• Cancer

• Any other serious disease