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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Li, Xiu-Min, M.D..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Li, Xiu-Min, M.D.
ClinicalTrials.gov Identifier:
NCT00602160
First received: January 15, 2008
Last updated: November 3, 2010
Last verified: November 2010
  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. We are enrolling those age 12-45 yrs old with allergies to peanut, tree nuts, sesame, fish, and/or shellfish.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Li, Xiu-Min, M.D.:

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: 68
Study Start Date: December 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

  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, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Locations
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.
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 by Li, Xiu-Min, M.D.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xiu-Min Li, M.D., Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00602160     History of Changes
Other Study ID Numbers: R01 AT001495-01A1, R01AT001495-01A1
Study First Received: January 15, 2008
Last Updated: November 3, 2010
Health Authority: United States: Food and Drug Administration

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:
Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on November 23, 2014