Therapeutic Effect of Chinese Herbal Medicine on Food Allergy

NCT00602160 | Unknown Phase 2 DMC

• 1 other identifier: R01AT001495-01A1
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Food Allergy

Keywords

Food allergy; Chinese Herbs; Investigational new drug; Herbs; Therapeutic medicine; Traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• Safety of FAHF-2

  1 year

Secondary Outcomes (1)

• lab studies

  1 year

Study Arms (2)

1

ACTIVE COMPARATOR

2 different dosages

Drug: FAHF-2 (TM)

2

PLACEBO COMPARATOR

Drug: FAHF-2 (TM)

Interventions

FAHF-2 (TM) DRUG

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.

1; 2

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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).
• 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.
• 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

Sponsors & Collaborators

• Li, Xiu-Min, M.D.: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

RECRUITING

Mount Sinai School Medicine

New York, New York, 10029, United States

RECRUITING

Related Publications (7)

• Wang Z, Wang ZZ, Geliebter J, Tiwari R, Li XM. Traditional Chinese medicine for food allergy and eczema. Ann Allergy Asthma Immunol. 2021 Jun;126(6):639-654. doi: 10.1016/j.anai.2020.12.002. Epub 2020 Dec 10.

  PMID: 33310179 DERIVED

• Wang J, Jones SM, Pongracic JA, Song Y, Yang N, Sicherer SH, Makhija MM, Robison RG, Moshier E, Godbold J, Sampson HA, Li XM. Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy. J Allergy Clin Immunol. 2015 Oct;136(4):962-970.e1. doi: 10.1016/j.jaci.2015.04.029. Epub 2015 Jun 1.

  PMID: 26044855 DERIVED

• Song Y, Wang J, Leung N, Wang LX, Lisann L, Sicherer SH, Scurlock AM, Pesek R, Perry TT, Jones SM, Li XM. Correlations between basophil activation, allergen-specific IgE with outcome and severity of oral food challenges. Ann Allergy Asthma Immunol. 2015 Apr;114(4):319-26. doi: 10.1016/j.anai.2015.01.006.

  PMID: 25841330 DERIVED

• Noone S, Ross J, Sampson HA, Wang J. Epinephrine use in positive oral food challenges performed as a screening test for food allergy therapy trials. J Allergy Clin Immunol Pract. 2015 May-Jun;3(3):424-8. doi: 10.1016/j.jaip.2014.10.008. Epub 2015 Jan 13.

  PMID: 25609353 DERIVED

• Yang N, Wang J, Liu C, Song Y, Zhang S, Zi J, Zhan J, Masilamani M, Cox A, Nowak-Wegrzyn A, Sampson H, Li XM. Berberine and limonin suppress IgE production by human B cells and peripheral blood mononuclear cells from food-allergic patients. Ann Allergy Asthma Immunol. 2014 Nov;113(5):556-564.e4. doi: 10.1016/j.anai.2014.07.021. Epub 2014 Aug 22.

  PMID: 25155085 DERIVED

• Patil SP, Wang J, Song Y, Noone S, Yang N, Wallenstein S, Sampson HA, Li XM. Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2) and inhibitory effect on basophils from patients with food allergy: Extended phase I study. J Allergy Clin Immunol. 2011 Dec;128(6):1259-1265.e2. doi: 10.1016/j.jaci.2011.06.015. Epub 2011 Jul 26.

  PMID: 21794906 DERIVED

• Wang J, Patil SP, Yang N, Ko J, Lee J, Noone S, Sampson HA, Li XM. Safety, tolerability, and immunologic effects of a food allergy herbal formula in food allergic individuals: a randomized, double-blinded, placebo-controlled, dose escalation, phase 1 study. Ann Allergy Asthma Immunol. 2010 Jul;105(1):75-84. doi: 10.1016/j.anai.2010.05.005.

  PMID: 20642207 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Julie Wang, M.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Xiu-Min Li

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Central Study Contacts

JingJing Mei

CONTACT

212-241-6577; jingjing.mei@mssm.edu

Sharon M Hamlin

CONTACT

212-241-1755; sharon.hamlin@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 28, 2008
• Study Start: December 1, 2007
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 4, 2010

Record last verified: 2010-11

Locations

US (2)