Status:
COMPLETED
Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome
Lead Sponsor:
Federal Stare Budgetary Scientific Institution, Mental Health Research Center
Collaborating Sponsors:
I.M. Sechenov First Moscow State Medical University
RML INVEST, Torkhovsky passage 10, Tula, Russian Federation
Conditions:
Irritable Bowel Syndrome
Irritable Bowel Syndrome With Diarrhea
Eligibility:
All Genders
18-59 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the efficacy and safety of a food supplement with standardized menthol, limonene, and gingerol content in patients with irritable bowel syndrome (IBS) or IBS/fun...
Detailed Description
Using a random number generator, 56 patients meeting inclusion criteria with IBS or IBS/FD were randomly assigned to either the intervention group (28 individuals) or the control group (28 individuals...
Eligibility Criteria
Inclusion
- irritable bowel syndrome (IBS)
- diarrhea-predominant IBS
- constipation-predominant IBS
- mixed-type IBS
- IBS/functional dyspepsia symptoms
- Must be able to swallow tablets
Exclusion
- organic bowel disease
- renal disease
- hepatic insufficiency,
- schizophrenia
- bipolar disorder
- epilepsy
Key Trial Info
Start Date :
February 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2019
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04484467
Start Date
February 9 2018
End Date
December 28 2019
Last Update
July 29 2020
Active Locations (1)
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1
Mental Health Research Center
Moscow, Russia