NCT00602160

Therapeutic Effect of Chinese Herbal Medicine on Food Allergy

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Li, Xiu-Min, M.D. · Individual
• Sex: All
• Age: 12 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Food Allergy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-12-01
• Primary completion: 2012-05-01
• Completion: 2012-06-01
• First posted: 2008-01-28
• Last updated: 2010-11-04

Locations

2 sites across 1 country: United States