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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00602160
Recruitment Status : Unknown
Verified November 2010 by Li, Xiu-Min, M.D..
Recruitment status was:  Recruiting
First Posted : January 28, 2008
Last Update Posted : November 4, 2010
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by:
Li, Xiu-Min, M.D.

Study Description
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Brief Summary:
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. We are enrolling those age 12-45 yrs old with allergies to peanut, tree nuts, sesame, fish, and/or shellfish.

Condition or disease Intervention/treatment Phase
Food Allergy Drug: FAHF-2 (TM) Phase 2

Detailed Description:

To address our hypothesis, we propose the following aims:

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Investigation of the Efficacy of the Food Allergy Herbal Formula (FAHF-2TM) in Patients With Food Allergy - Phase II Trial
Study Start Date : December 2007
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
2 different dosages
 Drug: 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.
Placebo Comparator: 2 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety of FAHF-2 [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. lab studies [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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, 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:

  • History of life-threatening anaphylaxis to peanut, tree nut, sesame, fish or shellfish (involving hypotension or requiring mechanical ventilation)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602160


Contacts
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Contact: JingJing Mei 212-241-6577 jingjing.mei@mssm.edu
Contact: Sharon M Hamlin 212-241-1755 sharon.hamlin@mssm.edu

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States
Contact: June Staw       JAStraw@uams.edu   
Contact: Christie Lynn       ChristieLynn@uams.edu   
Principal Investigator: Stacie Jones, MD         
United States, New York
Mount Sinai School Medicine Recruiting
New York, New York, United States, 10029
Principal Investigator: Julie Wang, M.D.         
Sponsors and Collaborators
Li, Xiu-Min, M.D.
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Julie Wang, M.D. Icahn School of Medicine at Mount Sinai
Study Director: Xiu-Min Li Icahn School of Medicine at Mount Sinai
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Xiu-Min Li, M.D., Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00602160    
Other Study ID Numbers: R01AT001495-01A1 ( U.S. NIH Grant/Contract )
R01AT001495-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: November 4, 2010
Last Verified: November 2010
Keywords provided by Li, Xiu-Min, M.D.:
Food allergy
Chinese Herbs
Investigational new drug
 Herbs
Therapeutic medicine
Traditional Chinese medicine
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate