Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT04484467
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2020-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D000077222', 'term': 'Limonene'}, {'id': 'C000713927', 'term': 'ginger extract'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D000081005', 'term': 'Cyclohexane Monoterpenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D039821', 'term': 'Monoterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Using a random number generator, 56 patients with IBS or IBS/FD were randomly assigned to either the intervention group (28 individuals) or control group (28 individuals).\n\nResearchers and patients were not informed who received a supplement or placebo.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'At Visit 1, all patients were randomly assigned into two groups. In the intervention group (Group 1), the supplement "Standart Zdorovya GASTRO" (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days. In the control group (Group 2), placebo (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days (Table 1). During the 30 days of the study, three outpatient visits were conducted (Visit 1 - Day 1, Visit 2 - Day 15 + 2 days, and Visit 3 - Day 30 + 2 days).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-26', 'studyFirstSubmitDate': '2020-07-20', 'studyFirstSubmitQcDate': '2020-07-20', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'timeFrame': 'Visit 1 - Day 1, Visit 2 - Day 15 +- 2 days, and Visit 3 - Day 30 +- 2 days', 'description': 'Symptom severity was tested with a "7x7" questionnaire at each visit.'}], 'secondaryOutcomes': [{'measure': 'Change in the number of SCFA producing bacteria', 'timeFrame': 'Visit 1 - Day 1, Visit 3 - Day 30 + 2 days', 'description': 'The qualitative and quantitative composition of the intestinal microbiota was assessed at Visits 1 and 3 based on 16S rRNA gene sequencing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional dyspepsia'], 'conditions': ['Irritable Bowel Syndrome', 'Irritable Bowel Syndrome With Diarrhea', 'Irritable Bowel Syndrome With Constipation', 'Irritable Bowel Syndrome Mixed']}, 'referencesModule': {'references': [{'pmid': '35704960', 'type': 'DERIVED', 'citation': 'Ivashkin VT, Kudryavtseva AV, Krasnov GS, Poluektov YM, Morozova MA, Shifrin OS, Beniashvili AG, Mamieva ZA, Kovaleva AL, Ulyanin AI, Trush EA, Erlykin AG, Poluektova EA. Efficacy and safety of a food supplement with standardized menthol, limonene, and gingerol content in patients with irritable bowel syndrome: A double-blind, randomized, placebo-controlled trial. PLoS One. 2022 Jun 15;17(6):e0263880. doi: 10.1371/journal.pone.0263880. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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) (Table 2). Non-functional causes for the symptoms were excluded by a detailed evaluation of the medical history, physical examination, extensive panel of blood tests, stool analysis, and colonoscopy with biopsies.\n\nDiarrhoea-predominant IBS patients (IBS-D) and mixed bowel habits IBS patients (IBS-M) were treated with smooth muscle antispasmodics. The constipation-predominant IBS patients (IBS-C) were treated with smooth muscle antispasmodics and laxatives. IBS/FD patients were treated with smooth muscle antispasmodics and proton pump inhibitors.\n\nAt Visit 1, all patients were randomly assigned into two groups. In the intervention group (Group 1), the supplement "Standart Zdorovya GASTRO" (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days. In the control group (Group 2), placebo (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days (Table 1). Researchers and patients were not informed who received a supplement or placebo. During the 30 days of the study, three outpatient visits were conducted (Visit 1 - Day 1, Visit 2 - Day 15 + 2 days, and Visit 3 - Day 30 + 2 days).\n\nSymptom severity was assessed on each visit using "7x7" questionnaire \\[Ivashkin, V., Sheptulin, A., Shifrin, O., Poluektova, E., Pavlov, C., Ivashkin, K., Drozdova, A., Lyashenko, O., Korolev, A., 2019. Clinical validation of the "7 × 7" questionnaire for patients with functional gastrointestinal disorders. J. Gastroenterol. Hepatol. 34, 1042-1048. https://doi.org/10.1111/jgh.14546\\], on 1 and 3 visits stool samples were collected for the qualitative and quantitative composition of the intestinal microbiota based on 16S rRNA gene sequencing.\n\nThe study protocol was approved by the Ethics Committee of the Mental Health Research Center, Moscow, Russian Federation (No. 418 dated 01/31/2018) and written informed consent was obtained from all participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* irritable bowel syndrome (IBS)\n* diarrhea-predominant IBS\n* constipation-predominant IBS\n* mixed-type IBS\n* IBS/functional dyspepsia symptoms\n* Must be able to swallow tablets\n\nExclusion Criteria:\n\n* organic bowel disease\n* renal disease\n* hepatic insufficiency,\n* schizophrenia\n* bipolar disorder\n* epilepsy'}, 'identificationModule': {'nctId': 'NCT04484467', 'briefTitle': 'Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Federal Stare Budgetary Scientific Institution, Mental Health Research Center'}, 'officialTitle': 'Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome: a Double-blind, Randomized, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'No. 418 dated 01/31/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Food supplement Standart Zdorovya GASTRO', 'description': 'In the intervention group (Group 1), the supplement "Standart Zdorovya GASTRO" (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days.', 'interventionNames': ['Dietary Supplement: Food Supplement With Standardized Menthol, Limonene, and Ginger']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'In the control group (Group 2), placebo (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Food Supplement With Standardized Menthol, Limonene, and Ginger', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Standart Zdorovya GASTRO'], 'description': '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', 'armGroupLabels': ['Food supplement Standart Zdorovya GASTRO']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Components of placebo Olive oil - 730 mg, 1 capsule, 730 mg, once a day for 30 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'Mental Health Research Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal Stare Budgetary Scientific Institution, Mental Health Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'I.M. Sechenov First Moscow State Medical University', 'class': 'OTHER'}, {'name': 'RML INVEST, Torkhovsky passage 10, Tula, Russian Federation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior research fellow, PHD', 'investigatorFullName': 'Allan G. Beniashvilia', 'investigatorAffiliation': 'Federal Stare Budgetary Scientific Institution, Mental Health Research Center'}}}}