Trial of Chinese Herbal Medicine in the Treatment of Upper Respiratory Tract Infections (URTIs)
Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
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
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