MedTrace Logo

Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome

NCT04484467 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-07-29

No results posted yet for this study

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/functional dyspepsia (FD).

Conditions

  • Irritable Bowel Syndrome
  • Irritable Bowel Syndrome With Diarrhea
  • Irritable Bowel Syndrome With Constipation
  • Irritable Bowel Syndrome Mixed

Interventions

DIETARY_SUPPLEMENT

Food Supplement With Standardized Menthol, Limonene, and Ginger

Components of Standart Zdorovya GASTRO: Peppermint oil (40% menthol, 1.5% limonene) - 240 mg, Ginger oil (14% gingerol) - 50 mg, olive oil - 440 mg, 1 capsule, 730 mg, once a day for 30 days

OTHER

Placebo

Components of placebo Olive oil - 730 mg, 1 capsule, 730 mg, once a day for 30 days

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    collaborator OTHER

  • RML INVEST, Torkhovsky passage 10, Tula, Russian Federation

    collaborator UNKNOWN

  • Federal Stare Budgetary Scientific Institution, Mental Health Research Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-09
Primary Completion
2019-12-28
Completion
2019-12-28

Countries

  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04484467 on ClinicalTrials.gov