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Immunotherapy

Chinese Herbal Medication for Food Allergy

Phase 2
Waitlist Available
Led By Julie Wang, MD
Research Sponsored by Xiu-Min Li
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
6 through 40 years
At least one of the following for each of the 3 study allergens: serum IgE >4 kU/L or skin prick test >6mm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 29
Awards & highlights

Study Summary

The purpose of this study is testing the use E-B-FAHF-2 Chinese herbal therapy in combination with multi-food oral immunotherapy (OIT) and Xolair® (Omalizumab) to help children and adults who are allergic to foods be able to safely tolerate food allergens. Specifically in this protocol, the food allergens are milk, egg, peanut, almond, cashew, hazelnut, walnut, sesame, and/or wheat. Omalizumab is considered an investigational drug for the treatment of food allergies in children and adults. Investigational means it has not been approved by the Food and Drug Administration (FDA) for use in the U.S. The researchers hope to learn whether the addition of Chinese herbal therapy (E-B-FAHF-2) can improve the outcome of sustained unresponsiveness (which is the ability to consume a food allergen and pass an oral food challenge after being off treatment for 3 months) as compared to placebo (i.e. subjects with OIT/Omalizumab + herbal vs. OIT/Omalizumab + placebo), and will help adults and children be able to safely ingest the foods they are allergic to.

Eligible Conditions
  • Food Allergy

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sustained unresponsiveness
Secondary outcome measures
Desensitizing to 4444mg
High level of desensitization to 7444mg or higher

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Chinese Herbal MedicationActive Control3 Interventions
Group II: PlaceboPlacebo Group3 Interventions

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Who is running the clinical trial?

Xiu-Min LiLead Sponsor
1 Previous Clinical Trials
35 Total Patients Enrolled
Julie Wang, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Mar 2025