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

November 3, 2010 updated by: Li, Xiu-Min, M.D.

Investigation of the Efficacy of the Food Allergy Herbal Formula (FAHF-2TM) in Patients With Food Allergy - Phase II Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

68

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai School Medicine
        • Principal Investigator:
          • Julie Wang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 43 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of FAHF-2
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
lab studies
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Li, Xiu-Min, M.D.

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

January 15, 2008

First Submitted That Met QC Criteria

January 15, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

November 4, 2010

Last Update Submitted That Met QC Criteria

November 3, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AT001495-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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