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

NCT00887172 | Completed Phase 4 DMC

• 1 other identifier: HKCTR-6
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Upper Respiratory Tract Infections

Keywords

Acute upper respiratory tract infections

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the proportion of patients who will have resolution on day 7.

  day 7

Secondary Outcomes (1)

• The secondary outcome measures are the duration from onset of the illness to the resolution of symptoms, change in daily symptom scores, SF-36 health-related quality of life scores and side effects.

  on day 0, 1, 4, 7, 10, 14, 20 and 21

Study Arms (4)

1

EXPERIMENTAL

Wind-cold syndrome group were patients classified by Chinese Medicine practitioner of Wind-cold syndrome and took treatment of Jing Fang Bai Du san.

Drug: Jing Fang Bai Du san

2

PLACEBO COMPARATOR

Wind-cold syndrome group were patients classified by Chinese Medicine practitioner of Wind-cold syndrome and took placebo of Jing Fang Bai Du san.

Drug: Placebo

3

EXPERIMENTAL

Wind-heat syndrome group were patients classified by Chinese Medicine practitioner of Wind-heat syndrome and took treatment of Ying Qiao san.

Drug: Ying Qiao san

4

PLACEBO COMPARATOR

Wind-heat syndrome group were patients classified by Chinese Medicine practitioner of Wind-heat syndrome and took placebo of Ying Qiao san.

Drug: Placebo

Interventions

Jing Fang Bai Du san DRUG

The Jing Fang Bai Du san can relieve external symptoms and effectively clear up the pathogenic cold. It contains 13 herbs including, Radix Angelicae Pubescentis, Radix Peucedani, Radix Ginseng, Smilacis Glabrae Rhizoma, Rhizoma Chuanxiong, Fructus Aurantii, Radix Platycodi, GlycyrrhizaeRadix, Herba Schizonepetae, Fructus Arctii, MenthaeFolium, Radix Saposhnikoviae, Rhizoma et Radix Notopterygii.The CHM preparations were manufactured and supplied by Pura Pharm International (H.K.) Ltd., in the form of concentrated granules which follows the GMP standard. None of the herbs in these two formulas are included in the Toxic Chinese Herbal Medicine List of the Chinese Medicine Ordinance Schedule 1 or being a controlled substance, animal product, or endangered species.

1

Placebo DRUG

The sachets of the CHM formulae and placebo were identical in appearance except for the randomization numbers. The placebo contains Maltose-dextrine granules that are identical in weight, appearance, flavour and texture as the CHM granules. Both the Chinese medicine practitioner who assessed the subjects and the subjects were blinded to the nature of the treatment. The pharmaceutical supplier kept the medication and placebo codes, which were broken at the end of the study after completion of all the assessment and data analyses.

2; 4

Ying Qiao san DRUG

The Ying Qiao san can relieve external symptoms and effectively clear up the pathogenic heat. It contains 10 herbs: Fructus Forsythiae, LoniceraeFlos, Radix Platycodi, MenthaeFolium, GlycyrrhizaeRadix, Herba Schizonepetae, Sojae Semen praeparatum, Fructus Arctii, PhragmitisRhizoma and LophatheriHerba. The CHM preparations were manufactured and supplied by Pura Pharm International (H.K.) Ltd., in the form of concentrated granules which follows the GMP standard. None of the herbs in these two formulas are included in the Toxic Chinese Herbal Medicine List of the Chinese Medicine Ordinance Schedule 1 or being a controlled substance, animal product, or endangered species.

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Two General Outpatient Clinics

Hong Kong, Hong Kong, China

Location

MeSH Terms

Interventions

jing fang bai du san

Study Officials

• Cindy L K Lam, MD

  Family Medicine Unit, Faculty of Medicine, HKU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 6, 2009
• First Posted: April 23, 2009
• Study Start: June 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: April 23, 2009

Record last verified: 2009-04

Locations

CN (1)