Clinical TrialID 1590
Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome
NCT04484467
Irritable Bowel Syndrome|Irritable Bowel Syndrome With Diarrhea|Irritable Bowel Syndrome With Constipation|Irritable Bowel Syndrome Mixed
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 1590
- Evidence Id
- 1590
- Core Evidence Id
- 1590
- Source Clinical Trial Id
- 1565
- Herb2 Clinical Trial Id
- HBCT001565
- Nct Id
- NCT04484467
- Title
- Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome
- Status
- Completed
- Phase
- Study Result
- No
- Study Condition
- Irritable Bowel Syndrome|Irritable Bowel Syndrome With Diarrhea|Irritable Bowel Syndrome With Constipation|Irritable Bowel Syndrome Mixed
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- DIETARY_SUPPLEMENT: Food Supplement With Standardized Menthol, Limonene, and Ginger|OTHER: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Double
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult
- Enrollment
- 56
- Outcome Measure
- Change in the severity of symptoms of irritable bowel syndrome (IBS) and functional dyspepsia (FD) (constipation-predominant, diarrhea-predominant, mixed-type IBS and IBS/FD), Symptom severity was tested with a "7x7" questionnaire at each visit., Visit 1 - Day 1, Visit 2 - Day 15 +- 2 days, and Visit 3 - Day 30 +- 2 days
- Sponsor Collaborator
- Federal Stare Budgetary Scientific Institution, Mental Health Research Center|I.M. Sechenov First Moscow State Medical University|RML INVEST, Torkhovsky passage 10, Tula, Russian Federation
- Funded By
- OTHER
- Location
- Mental Health Research Center, Moscow, Russian Federation
- Other Id
- No. 418 dated 01/31/2018
- Start Date
- 2018-02-09
- Primary Completion Date
- 2019-12-28
- Completion Date
- 2019-12-28
- First Posted
- 2020-07-23
- Results First Posted
- Last Update Posted
- 2020-07-29
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT04484467
- Title Cn
- Title En
- Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome
- Bilingual Status
- semi_complete