Therapeutic Effect of Chinese Herbal Medicine on Food Allergy
NCT ID: NCT00602160
Last Updated: 2010-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
68 participants
INTERVENTIONAL
2007-12-31
2012-06-30
Brief Summary
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Detailed Description
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Aim #1: To investigate the efficacy 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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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1
2 different dosages
FAHF-2 (TM)
We propose to test 10 tablets administered orally three times daily (t.i.d.) for 6 months in the Phase II study. The subjects will be randomized to 1 of 2 groups; FAHF-2 or Placebo group.
Both groups will undergo physician supervised Double-blinded placebo controlled food challenges, once during screening before starting treatment and again after 6 months of therapy.
2
FAHF-2 (TM)
We propose to test 10 tablets administered orally three times daily (t.i.d.) for 6 months in the Phase II study. The subjects will be randomized to 1 of 2 groups; FAHF-2 or Placebo group.
Both groups will undergo physician supervised Double-blinded placebo controlled food challenges, once during screening before starting treatment and again after 6 months of therapy.
Interventions
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FAHF-2 (TM)
We propose to test 10 tablets administered orally three times daily (t.i.d.) for 6 months in the Phase II study. The subjects will be randomized to 1 of 2 groups; FAHF-2 or Placebo group.
Both groups will undergo physician supervised Double-blinded placebo controlled food challenges, once during screening before starting treatment and again after 6 months of therapy.
Eligibility Criteria
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Inclusion Criteria
* History of allergy to peanut, tree nut, sesame, fish or shellfish as documented by a positive skin test and/or food allergen-specific IgE level.
* 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.
* Positive double-blind placebo controlled food challenge to peanut, tree nuts, sesame, fish, or shellfish.
* 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
* Allergy to corn
* 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
* Allergic gastrointestinal disease (e.g. allergic eosinophilic esophagitis/gastroenteritis
* 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 as defined by:
1. FEV1 value \<80% predicted or any clinical features of moderate or severe persistent asthma baseline severity (as defined by the 2007 NHLBI Guidelines) and greater than high daily doses of inhaled corticosteroids (as defined for children and adults using dosing tables from the 2007 NHLBI Guidelines).
2. Use of steroid medications in the following manners: history of daily oral steroid dosing for \>1 month during the past year, or burst or steroid course in the past 6 months, or \>1 burst oral steroid course in the past year.
3. Asthma requiring \>1 hospitalization in the past year for asthma or \>1 ED visit in the past 6 months for asthma.
* 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
* Use of omalizumab
* Use of beta blockers, ACE inhibitors, ARB, or calcium channel blockers, or history of ischemic heart disease
* Inability to discontinue use of antihistamines for skin testing or oral food challenges
* Inability to take the tablets
12 Years
45 Years
ALL
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Li, Xiu-Min, M.D.
INDIV
Responsible Party
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Mount Sinai School of Medicine
Principal Investigators
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Julie Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Xiu-Min Li
Role: STUDY_DIRECTOR
Icahn School of Medicine at Mount Sinai
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Mount Sinai School Medicine
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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June Staw
Role: primary
Christie Lynn
Role: backup
References
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