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Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||8 Years and Over|
- - Age 8 years or older with a history of allergic reaction to cod, shrimp or crab, manifested by any of the following: urticaria, angioedema, asthma or anaphylaxis, within 60 mins of ingestion.
- - Having a positive skin prick test to the cod, shrimp or crab as defined by a weal diameter 3 mm greater than the diluent control.
- - Having a positive oral challenge with freeze-dried cod, shrimp or crab.
- - Asthma must be under control with a FEV1 of at least 80% predicted value.
- - Aspirin, anti-histamines/anti-allergic medicines and antidepressants are not permitted for 3 days, one week and two weeks, respectively, before skin testing or oral food challenge.
- - Pregnancy.
- - Requiring systemic glucocorticoids, beta-blockers and ACE inhibitors.
- - Having poorly controlled asthma, poorly controlled atopic dermatitis prior to study.
- - Inability to discontinue antihistamines or other medication for skin testing and oral challenges.
- - Unable to comply with the study protocol for any reason.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Hong Kong Sanatorium & Hospital|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|June Chan, Master|
|Principal Investigator Affiliation||Hong Kong Sanatorium & Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Allergy to Fish, Allergy to Shrimp, Allergy to Crab|
The investigators aim to recruit 24 subjects for the present study. Subjects will be randomized into two groups, control group (n=12) and treatment group (n=12). At recruitment all subjects will be required to stop anti-allergic medicines and Chinese medicines as a wash out period for two weeks (week 1 and week 2). They will be required to keep a record of their symptoms and peak flow rates twice daily throughout the entire study. Skin prick test will be performed with a panel of commercially available skin test solutions for cod, shrimp and crab (ALK). Total and specific IgE as well as total and specific IgG4 for fish and shellfish will be measured (by the HKSH laboratory or CUHK laboratory). Graded open cod, shrimp or crab challenge will be performed as described later at HKSH in each patient to determine the baseline tolerance level to fish or shellfish, using freeze-dried cod, shrimp or crab as appropriate. After determining the baseline tolerance level, subjects in the treatment group will take 2 grams of the CHFX or placebo daily for 8 weeks (week 4 to week 11). The placebo powder consists of food grade medicinal starch blended with coloring agent. After the 8 weeks of treatment, skin prick tests, blood tests as at baseline and oral challenges will be repeated (week 12). During the study subjects will be requested to consume their normal diet but avoiding fish and shellfish, with no consumption of any other Chinese herbal medication. They can take anti-allergic medicines as necessary but will note when medicines are taken in their symptom and peak flow diary.
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