Clinical Trials

Title: Effectiveness of Chinese Herbal Therapy for Asthma

Asthma is a major public health problem worldwide, particularly in westernized societies, and has continued to increase in prevalence over the past two decades. Inhaled corticosteroids have become the first-line treatment for persistent asthma even though significant side effects have been reported. New asthma medications, including leukotriene inhibitors and anti-IgE, have shown only marginal benefits. Patients have increasingly turned to complementary and alternative medicine (CAM) for treatment of their asthma, despite the uncertainty of its benefits due a lack of well-controlled scientific studies.

The Mount Sinai Health System has launched an NIH-funded program for a clinical trial to treat asthma patients with Chinese herbal medicine. Our medical team has developed a natural formula containing three herbs (known as ASHMI), all of which have an extensive history of treatment in asthma sufferers in China.

Currently, we have completed phase I of this study and are now in the process of enrolling patients for phase II. We are looking for people with asthma to take this herbal formula, in addition to their regular asthma medications, for six months. If you are between 18-55 years old, non-smoking, and have been diagnosed with asthma, you may be eligible to join this clinical trial. There will be a screening visit, eight follow-up visits, and an exit visit (for a total of 10 visits). The first visit will include a physical examination, allergy and breathing tests, an electrocardiogram, and routine blood and urine tests. You will be compensated up to $550 for your time and travel expenses.


Title: Investigation of the Safety of the Food Allergy Herbal Formula (FAHF-2TM) in Patients with Food Allergy – Phase 1 and Phase 1 Extension Trial

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 percent of young children and 3 to 4 percent of adults. While the majority of children outgrow their allergy to milk, egg, wheat, and soy, allergies to peanuts, tree nuts, fish, and shellfish are often life-long. Currently, there are no treatments that can cure or provide long-term remission from food allergies. Based on our preliminary studies, we hypothesize that our investigational botanical drug, FAHF-2TM, will be a safe and effective herbal therapy for food allergies. We propose to test 4 tablets, 6 tablets, or 12 tablets of FAHF-2 TM administered orally three times daily (t.i.d.) for seven days in the Phase 1 study. Following the early safety trial, the same 18 subjects from the initial Phase I trial will be enrolled into a six-month, long-term, open-label extension safety trial. The subjects will all receive six tablets of FAHF-2 TM three times a day.

Title: Double-Blind, Placebo-Controlled Phase 2 Study to Assess Safety and Efficacy of Chinese Herbal Therapy and Multiple Food Allergen Oral Immunotherapy

Sponsor: Icahn School of Medicine at Mount Sinai. Xiu-Min Li, MD

Investigator: Icahn School of Medicine at Mount Sinai. Julie Wang. MD

Johns Hopkins University, Robert Wood, MD

Study Start: August 2016

Primary Completion: December 2019 [Anticipated]

Brief 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 consideredan 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.