Therapeutic Effect of Chinese Herbal Medicine on Food Allergy - Full Text View

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00602160

Purpose

The increasing prevalence of allergic diseases in westernized 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 hypothesize that our investigational botanical drug, FAHF-2TM, will be a safe and effective herbal therapy for food allergy.

Condition	Intervention	Phase
Food Allergy	Drug: FAHF-2 (TM)	Phase I

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Food Allergy

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Safety of FAHF-2 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

lab studies [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 2 different dosages	Drug: FAHF-2 (TM) We propose to test 4 tablets, 6 tablets, or 12 tablets of FAHF-2 administered orally three times daily (t.i.d.) for 7 days in the Phase 1 study. Following the early safety trial, the same 18 subjects from the initial Phase I trial will be enrolled into a 6 month long-term, open-label extension safety trial. The subjects will be randomized to two FAHF-2 dose groups (no placebo group).
2: Placebo Comparator	Drug: FAHF-2 (TM) We propose to test 4 tablets, 6 tablets, or 12 tablets of FAHF-2 administered orally three times daily (t.i.d.) for 7 days in the Phase 1 study. Following the early safety trial, the same 18 subjects from the initial Phase I trial will be enrolled into a 6 month long-term, open-label extension safety trial. The subjects will be randomized to two FAHF-2 dose groups (no placebo group).

Arms

Assigned Interventions

1: Active Comparator

2 different dosages

Drug: FAHF-2 (TM)

We propose to test 4 tablets, 6 tablets, or 12 tablets of FAHF-2 administered orally three times daily (t.i.d.) for 7 days in the Phase 1 study. Following the early safety trial, the same 18 subjects from the initial Phase I trial will be enrolled into a 6 month long-term, open-label extension safety trial. The subjects will be randomized to two FAHF-2 dose groups (no placebo group).

2: Placebo Comparator

Drug: FAHF-2 (TM)

We propose to test 4 tablets, 6 tablets, or 12 tablets of FAHF-2 administered orally three times daily (t.i.d.) for 7 days in the Phase 1 study. Following the early safety trial, the same 18 subjects from the initial Phase I trial will be enrolled into a 6 month long-term, open-label extension safety trial. The subjects will be randomized to two FAHF-2 dose groups (no placebo group).

Detailed Description:

To address our hypothesis, we propose the following aims:

Aim #1: To investigate the safety of FAHF-2TM for food allergy (in addition to current food allergen avoidance).

Aim #2: To characterize the immunomodulatory effects of FAHF-2TM on food allergic patients

Eligibility

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

Criteria

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 pediatric 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602160

Locations

United States, New York
Mount Sinai School Medicine
New York, New York, United States, 10029

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:	Julie Wang, M.D.	Mount Sinai School of Medicine
Study Director:	Xiu-Min Li	Mount Sinai School of Medicine

More Information

No publications provided

Responsible Party:	Mount Sinai School of Medicine ( Xiu-Min Li, M.D. )
Study ID Numbers:	R01AT001495-01A1
Study First Received:	January 15, 2008
Last Updated:	August 17, 2009
ClinicalTrials.gov Identifier:	NCT00602160 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Food allergy
Chinese Herbs
Investigational new drug
Herbs
Therapeutic medicine

Additional relevant MeSH terms:

Food Hypersensitivity
Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on November 30, 2009