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

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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.

Tracking Information
First Submitted Date  ICMJE January 15, 2008
First Posted Date  ICMJE January 28, 2008
Last Update Posted Date November 4, 2010
Study Start Date  ICMJE December 2007
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
Safety of FAHF-2 [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
lab studies [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Effect of Chinese Herbal Medicine on Food Allergy
Official Title  ICMJE Investigation of the Efficacy of the Food Allergy Herbal Formula (FAHF-2TM) in Patients With Food Allergy - Phase II Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Food Allergy
Intervention  ICMJE 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.

Study Arms  ICMJE
  • Active Comparator: 1
    2 different dosages
    Intervention: Drug: FAHF-2 (TM)
  • Placebo Comparator: 2
    Intervention: Drug: FAHF-2 (TM)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 3, 2010)
68
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2008)
18
Estimated Study Completion Date  ICMJE June 2012
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00602160
Other Study ID Numbers  ICMJE R01AT001495-01A1( U.S. NIH Grant/Contract )
R01AT001495-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiu-Min Li, M.D., Mount Sinai School of Medicine
Study Sponsor  ICMJE Li, Xiu-Min, M.D.
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
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
PRS Account Li, Xiu-Min, M.D.
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP