|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Li, Xiu-Min, M.D. |
|---|---|
| Collaborator: |
National Center for Complementary and Alternative Medicine (NCCAM) |
| Information provided by: | Li, Xiu-Min, M.D. |
| ClinicalTrials.gov Identifier: | NCT00602160 |
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 II |
| 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 |
| 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. |
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 |
Inclusion Criteria:
Exclusion Criteria:
Current uncontrolled moderate to severe asthma as defined by:
Contacts and Locations| Contact: JingJing Mei | 212-241-6577 | jingjing.mei@mssm.edu |
| Contact: Sharon M Hamlin | 212-241-1755 | sharon.hamlin@mssm.edu |
| 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. | |
| Principal Investigator: | Julie Wang, M.D. | Mount Sinai School of Medicine |
| Study Director: | Xiu-Min Li | Mount Sinai School of Medicine |
More Information
| 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 |
|
Food allergy Chinese Herbs Investigational new drug |
Herbs Therapeutic medicine Traditional Chinese medicine |
|
Hypersensitivity Food Hypersensitivity Immune System Diseases Hypersensitivity, Immediate |