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Herbal Formula
Oral E-B-FAHF-2 for Crohn's Disease
Phase 1
Recruiting
Led By David Dunkin, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects weighing 25kg or more
Be between 18 and 65 years old
Must not have
Use of intravenous or oral systemic steroids within the past six months or any use of immunomodulators or biologic medications, since these drugs have lasting effects and alter the subject's cytokine profile thus affecting the results of the study.
Abnormal hepatic function (ALT, AST or bilirubin >2 x upper limit of normal).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Summary
This trial is investigating whether a more concentrated form of an herbal remedy is safe and effective for treating mild-to-moderate Crohn's disease.
Who is the study for?
Adults aged 18-30 with recently diagnosed mild-to-moderate Crohn's disease, able to undergo endoscopy and colonoscopy. Participants must be in good health, able to swallow pills, immunized per CDC guidelines, and if female and of childbearing potential, using effective birth control. Exclusions include severe CD cases, abnormal organ function tests, concurrent strong medication interactions, other systemic diseases or experimental therapy within the last month.
What is being tested?
The trial is testing E-B-FAHF-2 (a concentrated herbal formula) against a placebo for safety and effectiveness in maintaining remission of mild-to-moderate Crohn's disease. The study will also examine the effects on immune cells and intestinal mucosa to assess whether further efficacy trials are warranted.
What are the potential side effects?
While specific side effects are not listed for E-B-FAHF-2 as it is under investigation, participants may experience reactions typical of herbal supplements such as gastrointestinal discomfort or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 25kg.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken steroids, immunomodulators, or biologic medications in the last six months.
Select...
My liver tests are higher than normal.
Select...
I have active disease around my rectum, including fistulas or abscesses.
Select...
I use complementary or alternative medicine products.
Select...
My initial tests show I have severe disease with significant damage seen during endoscopy.
Select...
My kidney function tests are not normal.
Select...
I am not taking any medications that affect CYP3A enzyme activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of grades of adverse events
Secondary study objectives
Fecal Calprotectin
Peripheral blood mononuclear cell (cell)
Number of participants requiring an escalation in therapy.
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: E-B-FAHF-2Experimental Treatment1 Intervention
Low dose EBFAHF-2 (29 mg/kg/d divided two times a day) for 2 weeks followed by a full dose (71mg/kg/d divided two times a day) for 6 weeks
Group II: PlaceboPlacebo Group1 Intervention
capsules are identical in appearance to EBFAHF-2 capsules
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,793 Total Patients Enrolled
David Dunkin, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken steroids, immunomodulators, or biologic medications in the last six months.My liver tests are higher than normal.I have active disease around my rectum, including fistulas or abscesses.I use complementary or alternative medicine products.I am between 18-30 years old with Crohn's disease and generally healthy.I weigh at least 25kg.My initial tests show I have severe disease with significant damage seen during endoscopy.You are allergic to FAHF-2/B-FAHF-2 or any of its ingredients.I am not pregnant or breastfeeding, and I can provide negative pregnancy tests.I am willing to have upper endoscopy and colonoscopy for Crohn's disease monitoring.I do not have any other major illnesses that would stop me from joining this study.I was diagnosed with mild-to-moderate Crohn's disease in my ileum or ileum-colon area within the last year.I am using or willing to use effective birth control during the study.My kidney function tests are not normal.I am not taking any medications that affect CYP3A enzyme activity.
Research Study Groups:
This trial has the following groups:- Group 1: E-B-FAHF-2
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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