Clinical Trial: Therapeutic Effect of Chinese Herbal Medicine on Food Allergy

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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 Summary:

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

Sponsor: Li, Xiu-Min, M.D.

Current Primary Outcome: Safety of FAHF-2 [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: lab studies [ Time Frame: 1 year ]

Original Secondary Outcome: Same as current

Information By: Li, Xiu-Min, M.D.

Dates:
Date Received: January 15, 2008
Date Started: December 2007
Date Completion: June 2012
Last Updated: November 3, 2010
Last Verified: November 2010