Therapeutic Effect of Chinese Herbal Medicine on Food Allergy (FAHF-2)

The increasing prevalence of allergic diseases in westernised countries poses a significant health problem and a tremendous burden on quality of life and healthcare expenditure. Food allergy affects as many as 6% of young children and 3% to 4% of adults. While the majority of children outgrow their allergy to milk, egg, wheat and soy, allergies to peanut, tree nuts, fish and shellfish are often life-long. Currently, there are no treatments that can cure or provide long-term remission from food allergy. Based on our preliminary studies, we hypothesise that our investigational botanical drug, FAHF-2TM, will be a safe and effective herbal therapy for food allergy.

Official Title

Investigation of the Safety of the Food Allergy Herbal Formula (FAHF-2TM) in Patients With Food Allergy – Phase 1 and Phase 1 Extension Trial.

Conditions

Food Allergy

Study Type

Interventional

Study Design

Other, Randomised, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study.

Further Details

Primary Outcome Measures:

Safety of FAHF-2

Secondary Outcome Measures:

Lab studies

Study Start

December 2007

Eligibility & Criteria

Ages Eligible for Study: 12 Years to 45 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Male and female subjects ages 12 through 45 years of age and otherwise in good health as determined by medical history and physical examination
History of allergy to peanut, tree nut, fish or shellfish as documented by a positive skin test and/or food allergen-specific IgE level [skin prick test positive (end-point prick skin test titration performed in duplicate, one in each arm; mean wheal diameter >5 mm greater than mean of saline control; peanut, tree nut, fish or shellfish specific IgE > 0.7 kU/L)
The subject agrees to participate in the study or the subject’s parent or legal guardian is willing and able to give written informed consent, and the paediatric subject gives assent for participation in the study.
Females of childbearing potential must be inactive sexually or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study

Exclusion Criteria:

Acute febrile illness (such as cold, flu, etc.) within one week before administration of study drug
Any history of systemic disease that in the investigator’s opinion would preclude the subject from participating in this study, e.g. autoimmune disease, neoplasms, HIV or hepatitis virus infection
Abnormal hepatic function (ALT/AST and bilirubin >1.25 x upper limit of normal)
Abnormal bone marrow function (WBC <4 x 103/mm3; platelets <100 x 103/mm3; hgb <11 g/dl)
Abnormal renal function (BUN and creatinine >1.25 x upper limit of normal)
Clinically significant abnormal electrocardiogram
Current uncontrolled moderate to severe asthma with FEV1 <80% predicted
Participation in another experimental therapy study within 30 days of this study
History of alcohol or drug abuse
Currently taking antidepressant medication
Pregnant or lactating female subjects. Females of childbearing potential will need a negative serum pregnancy test at screening to be considered for this study