Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT01388933
Eligibility Criteria:
Inclusion Criteria:
* provide written informed consent
* ability to orally ingest study medication
* male or female between 18 to 75 inclusive
* diagnosed with Crohn's disease for at least 3 months
* CDAI score of 220-300 at screening
* sexually active participants of childbearing potential must agree to birth control
* no clinically significant conditions which the doctor would feel exclusionary
* stable medication (including probiotics)
Exclusion Criteria:
* history of any bowel condition that may interfere with the evaluation of the study drug
* positive stool cultures
* currently pregnant or lactating
* receiving total parenteral nutrition
* history of alcohol or drug abuse within one year
* history of malignancy within 5 years
* current use of anticholinergic agents, antidepressants during the study, warfarin, prokinetics, antipsychotic agents or narcotic analgesics
* treatment with Anti-TNF agents 12 weeks before screening
* treatment with corticosteroids four weeks prior to screening
* treatment with cyclosporine or tacrolimus eight weeks prior to screening
* presence of a poorly controlled medical condition
* history of allergic reaction to ginseng, ginger or sichuan pepper
* any use of supplemental ginger, ginseng and Sichuan powder 2 weeks prior to and through course of the trial
* current use of any of the following herbal medications: Boswellia, Cat's claw (Uncaria tomentosa), Cayenne pepper, Echinacea, Horsetail (Equisetum), Hops, Lady's mantle (Alchemilla), Marshmallow root (Althaea), Slippery elm (Ulmus rubra) Turmeric and White Willow (Salix alba)
* history of celiac disease
* current diagnosis of lactose intolerance
* history of any other investigational medication within 30 days of enrolling in study
* unsuitability as determined by the study doctor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01388933
Study Brief:
Protocol Section:
NCT01388933