Acute Upper Respiratory Tract InfectionsPhase 4NCT00887172
Trial of Chinese Herbal Medicine in the Treatment of Upper Respiratory Tract Infections (URTIs)
A Phase 4 study testing Jing Fang Bai Du san and Ying Qiao san in people with Acute Upper Respiratory Tract Infections, run by The University of Hong Kong at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Upper Respiratory Tract Infections
- What is being tested?
- Jing Fang Bai Du san and Ying Qiao san
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 327 participants
- Where
- 1 siteChina
- Study dates
- Jun 2005to Jun 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double Blind, Placebo-Controlled Clinical Trial of Chinese Herbal Medicine (CHM) in the Treatment of Acute Upper Respiratory Tract Infections
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.
Read more
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.
Read the detailed description
Acute upper respiratory tract infections (URTIs) are the most common diagnoses made in the primary medical services, which consisted of 34.6% of all diagnoses in Hong Kong. It accounts for approximately 100 million visits per year in the US. It was estimated that an adult has an average of 3 to 4 times while children has an average of 6 to 8 times each year. WHO has pointed out that URTIs have a great impact on personal and economical aspects although they are rarely lethal It was estimated that 60% of the working class has contracted URTIs each year, and a loss of 8.8 days of perfect health for each worker on average each year, and a loss of up to HK$ 31.3 billion of economic output each year.
There is no established curative treatment in Western medicine for URTIs except for selected cases of influenza. Studies have shown that the average duration of illness of an URTI is around 7 days, and most URTIs resolve by the 10th day. Traditional Chinese medicine (TCM) is commonly used by people in Hong Kong on its own or along side with Western medicine for the treatment of URTIs. The Chinese Medicine Council of Hong Kong was established in September 1999, the use of Chinese herbal medicine (CHM) is expected to increase and there is an urgent need for research evidence on their effectiveness and side effects. TCM follows a theoretical and methodological pathway, which leads to its diagnosis and treatment. Most URTIs can be differentiated into two types according to the theory of TCM: Wind-cold syndrome and Wind-heat syndrome. The theory leads to two classical herbal formulae that are very popular in Hong Kong: the Jing Fang Bai Du san for treating the Wind-cold syndrome whiles the Ying Qiao san for treating Wind-heat syndrome.
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. Previous clinical studies conducted in China showed mixed results on the effectiveness of Jing Fang Bai Du san on Wind-cold syndrome. One study showed that it was no better than no treatment while another study showed that concentrated granules of Jing Fang Bai Du san was more effective (80%) than Western medicine (10%) in improving and resolving symptoms of Wind-cold syndrome within 7 days.
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. From pharmacological studies, it showed anti-inflammatory, antipyretic, analgesic, anti-bacterial and antiviral actions. A clinical trial also showed the concentrated granules of Ying Qiao san was more effective (66.13%) than Western medicine (40%) in resolving the symptoms of Wind-heat syndrome within 1 week. These two CHM formulae have been used for many years and have not been associated with any serious adverse reactions. The common side effects are mild diarrhoea and headache.
Although there are some data from Mainland China suggesting the effectiveness of these two formulae for URTIs but most of these previous studies were observational and the few clinical trials were not placebo-controlled and of poor quality. Furthermore, results of trials from Mainland China may not be generalisable to the people in Hong Kong. Most previous studies on CHM focused on individual herbs, which is against the TCM principles as pointed out by the WHO. The WHO recommends that future clinical studies should attempt to integrate TCM diagnosis pattern with traditional CHM treatments. In this proposed study, the integrated TCM approach of using traditional formulae of multiple herbs, guided by the TCM diagnosis, will be used in a double-blind randomized placebo-controlled trial.
- Conditions
- Acute Upper Respiratory Tract Infections
- Being tested
- Jing Fang Bai Du san, Placebo, Ying Qiao san
- Keywords
- Acute upper respiratory tract infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jing Fang Bai Du sanDrug
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.
PlaceboDrug
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.
Ying Qiao sanDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the proportion of patients who will have resolution on day 7.
Measured: 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.
Measured: on day 0, 1, 4, 7, 10, 14, 20 and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startJun 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Fund for the Control of Infectious Diseases of the Food and Health Bureau, the Government of the Hong Kong SAR
- Investigators
- Cindy L K Lam, MD, Principal investigator, Family Medicine Unit, Faculty of Medicine, HKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887172
- Sponsor's protocol ID
- HKCTR-6
- Status last verified
- Apr 2009
- First submitted
- 6 Apr 2009
- Last updated
- 23 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind, Placebo-Controlled Clinical Trial of Chinese Herbal Medicine (CHM) in the Treatment of Acute Upper Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT00887172
- Acronym / sponsor ID
- HKCTR-6
- Conditions
- Acute Upper Respiratory Tract Infections
- Keywords
- Acute upper respiratory tract infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Research Fund for the Control of Infectious Diseases of the Food and Health Bureau, the Government of the Hong Kong SAR
- Study start
- Jun 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute upper respiratory tract infections (URTIs) are the most common diagnoses made in the primary medical services, which consisted of 34.6% of all diagnoses in Hong Kong. It accounts for approximately 100 million visits per year in the US. It was estimated that an adult has an average of 3 to 4 times while children has an average of 6 to 8 times each year. WHO has pointed out that URTIs have a great impact on personal and economical aspects although they are rarely lethal It was estimated that 60% of the working class has contracted URTIs each year, and a loss of 8.8 days of perfect health for each worker on average each year, and a loss of up to HK$ 31.3 billion of economic output each year.
There is no established curative treatment in Western medicine for URTIs except for selected cases of influenza. Studies have shown that the average duration of illness of an URTI is around 7 days, and most URTIs resolve by the 10th day. Traditional Chinese medicine (TCM) is commonly used by people in Hong Kong on its own or along side with Western medicine for the treatment of URTIs. The Chinese Medicine Council of Hong Kong was established in September 1999, the use of Chinese herbal medicine (CHM) is expected to increase and there is an urgent need for research evidence on their effectiveness and side effects. TCM follows a theoretical and methodological pathway, which leads to its diagnosis and treatment. Most URTIs can be differentiated into two types according to the theory of TCM: Wind-cold syndrome and Wind-heat syndrome. The theory leads to two classical herbal formulae that are very popular in Hong Kong: the Jing Fang Bai Du san for treating the Wind-cold syndrome whiles the Ying Qiao san for treating Wind-heat syndrome.
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. Previous clinical studies conducted in China showed mixed results on the effectiveness of Jing Fang Bai Du san on Wind-cold syndrome. One study showed that it was no better than no treatment while another study showed that concentrated granules of Jing Fang Bai Du san was more effective (80%) than Western medicine (10%) in improving and resolving symptoms of Wind-cold syndrome within 7 days.
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. From pharmacological studies, it showed anti-inflammatory, antipyretic, analgesic, anti-bacterial and antiviral actions. A clinical trial also showed the concentrated granules of Ying Qiao san was more effective (66.13%) than Western medicine (40%) in resolving the symptoms of Wind-heat syndrome within 1 week. These two CHM formulae have been used for many years and have not been associated with any serious adverse reactions. The common side effects are mild diarrhoea and headache.
Although there are some data from Mainland China suggesting the effectiveness of these two formulae for URTIs but most of these previous studies were observational and the few clinical trials were not placebo-controlled and of poor quality. Furthermore, results of trials from Mainland China may not be generalisable to the people in Hong Kong. Most previous studies on CHM focused on individual herbs, which is against the TCM principles as pointed out by the WHO. The WHO recommends that future clinical studies should attempt to integrate TCM diagnosis pattern with traditional CHM treatments. In this proposed study, the integrated TCM approach of using traditional formulae of multiple herbs, guided by the TCM diagnosis, will be used in a double-blind randomized placebo-controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Jing Fang Bai Du sanWind-cold syndrome group were patients classified by Chinese Medicine practitioner of Wind-cold syndrome and took treatment of Jing Fang Bai Du san. |
| 2 | Placebo comparator | Drug: PlaceboWind-cold syndrome group were patients classified by Chinese Medicine practitioner of Wind-cold syndrome and took placebo of Jing Fang Bai Du san. |
| 3 | Experimental | Drug: Ying Qiao sanWind-heat syndrome group were patients classified by Chinese Medicine practitioner of Wind-heat syndrome and took treatment of Ying Qiao san. |
| 4 | Placebo comparator | Drug: PlaceboWind-heat syndrome group were patients classified by Chinese Medicine practitioner of Wind-heat syndrome and took placebo of Ying Qiao san. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients will be included if they have all the following:
- 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.
Key exclusion criteria (12 listed)
- Patients will be excluded from the study if they have one or more of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jing Fang Bai Du sanThe 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. | Drug | 1 |
| PlaceboThe 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. | Drug | 2, 4 |
| Ying Qiao sanThe 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. | Drug | 3 |
Primary outcome
The primary outcome measure is the proportion of patients who will have resolution on day 7.
Time frame: day 7
1 secondary outcome
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.
Time frame: on day 0, 1, 4, 7, 10, 14, 20 and 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy L K Lam, MD principal investigator
Family Medicine Unit, Faculty of Medicine, HKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Jing Fang Bai Du san and Ying Qiao san in people with Acute Upper Respiratory Tract Infections, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is the proportion of patients who will have resolution on day 7. (time frame: day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2009.