Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:49 PM
Study NCT ID:
NCT06157034
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2020-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prokinetic Effect of Selected Nutraceuticals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Phase1 - 200 population size will be divided into 4 treatment groups\n\nPhase2\n\n* The phase will check the impact of selected nutraceuticals on TB patients with dietary counseling and all collected data in Phase1 will be repeated at the end\n* 3 selected nutraceuticals Zingiber officinale, Carum carvi, and Mentha spicata will be used against placebo and each placed in a separate group with 50 subjects for 3 months\n* Before dispensing treatments, raw material will be processed and encapsulated in prescribed doses in 4 groups after breakfast and dinner T1-Placebo 100mg/d, T2-Zingiber Officinale powder (500mg 2x/d=1000mg/d), T3-Carum powder(1g 2x/d=2g/d), T4-Mentha oil(2% of oil1.5ml 2x/d=30mg/d)\n\nPhase3\n\n\\- The impact of withholding the intervention will be studied to observe any change in selected parameters'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-03', 'studyFirstSubmitDate': '2020-11-01', 'studyFirstSubmitQcDate': '2023-12-03', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '--GIT disturbances', 'timeFrame': '"1 Month" at study commencement (Phase 1)', 'description': 'GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 1.'}, {'measure': 'GIT disturbances', 'timeFrame': 'Termination of Phase 2 (Intervention period) "3 Months"', 'description': 'GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 2 after completion of three-month intervention.'}, {'measure': 'GIT disturbances', 'timeFrame': 'Termination of phase 3 (Washout period) "1 Month"', 'description': 'GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 3 which is wash out time.'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': '"through study completion, an average of 9 months"', 'description': 'Measurements will be taken in triplicate. Height will be measured to the nearest 0.5 cm with a stadiometer (or knee height, ulnar length or arm span \\[demispan\\] for those persons unable to stand fully erect); body weight will be measured to the nearest 0.1 kg.'}, {'measure': 'A self-designed / pretested questionnaire', 'timeFrame': '"through study completion, an average of 9 months"', 'description': 'will be used to collect data on other determinants that affect patients regarding disease history, and dietary history. Agarwal Socio-economic status (SES) performa will be used.'}, {'measure': 'Acid-Fast Bacillus (sputum)', 'timeFrame': '"through study completion, an average of 9 months"', 'description': 'sample will be taken at time of enrollment in study to make diagnosis of Tuberculosis'}, {'measure': 'Chest X-ray (CXR)', 'timeFrame': '"1 Day" at study commencement (Phase 1)', 'description': 'Phase 1 in which subjects will be enrolled and their CXR will be taken as criteria for diagnosis of TB'}, {'measure': 'Complete blood count (CBC)', 'timeFrame': '"1 Day" at study commencement (Phase 1)', 'description': 'Phase 1 in which subjects will be enrolled and their CBC will be taken as criteria for diagnosis of TB'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Tuberculosis', 'Gastro-Intestinal Disorder']}, 'descriptionModule': {'briefSummary': 'Anti-Tuberculosis Treatment (ATT) is one of the effective treatments of tuberculosis but the use of drugs for a long time put an adverse effect on the gut and other organs of the body. Nutraceuticals are the cheapest natural sources with therapeutic effects. These natural medicines help in alleviating gastrointestinal disturbances. This study will be conducted to overcome gastrointestinal issues with the help of nutraceuticals, which are more acceptable by the majority and have no side effects.', 'detailedDescription': 'The aim of this study will be to evaluate if Zingiber officinale, Carum carvi, L, and Mentha spicata L nutraceuticals can help in alleviating gastrointestinal disturbances in subjects which are more acceptable by the majority and have no side effects.\n\nThis Randomized Control interventional three arms Trial will comprise three phases. Patients will be randomized to Zingiber officinale, Carum carvi, L, and Mentha spicata L nutraceuticals or placebo for three months. We will evaluate symptoms assessment, dietary assessment, biochemical and physical analysis i.e. Acid-Fast Bacillus (AFB) for sputum, Chest X-ray (CXR), and Complete Blood Count (CBC) at baseline and after 3 months since the study started.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed Pulmonary TB patients (both genders)\n* Age group 18-65 years\n* Symptoms criteria (Rome IV)\n\nExclusion Criteria:\n\n* Patients ˃ 18 years and ˂ 65 years.\n* Patients registered with extra pulmonary disease'}, 'identificationModule': {'nctId': 'NCT06157034', 'briefTitle': 'Prokinetic Effect of Selected Nutraceuticals', 'organization': {'class': 'OTHER', 'fullName': 'Allama Iqbal Open University Islamabad'}, 'officialTitle': 'Prokinetic Effect of Selected Nutraceuticals on Management of Gastrointestinal Disturbances Among Pulmonary Tuberculosis Patients', 'orgStudyIdInfo': {'id': 'Allama Iqbal Open University.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Exploratory', 'description': '* After sampling the study population of 200 will be divided into four (04) treatment groups i.e. T1 (Placebo), T2 (Zingiber officinale), T3 (Carum carvi, L), and T4 (Mentha spicata L).\n* Each group will be allotted 50 subjects'}, {'type': 'EXPERIMENTAL', 'label': 'T1', 'description': "* In the pursuit of scientific understanding, clinical studies play a pivotal role in evaluating the efficacy of treatments. One essential aspect is the inclusion of a placebo group, denoted as the T1 group in this study. Participants in this group will be administered inert material in the form of 100 mg capsules, serving as a baseline for comparison against the active treatment groups.\n* Group Designation: T1 Placebo Group\n\n * Intervention: 100 mg capsule containing inert material\n * Dosage Frequency: Daily\n * Duration: 3 months\n * Number of Participants: 50 subjects\n* Participants in the T1 Placebo Group are fully informed about the nature of the study, including the possibility of receiving a placebo.\n* Informed consent is obtained from each participant, ensuring that they are aware of the study's objectives and the potential for receiving an inactive treatment.", 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'T2', 'description': '* Zingiber officinale, commonly known as ginger, has been of interest for its potential health benefits.\n* In this clinical study, the T2 treatment group is designated to receive Zingiber officinale powder.\n* Intervention Details:\n\n * Group Designation: T2 Treatment Group\n * Intervention: Zingiber officinale powder\n * Dosage: 500 mg capsules\n * Dosage Frequency: Twice daily\n * Total Daily Dosage: 1000 mg\n * Administration Timing: After breakfast and dinner\n * Duration: 3 months\n* Throughout the study duration, data will be systematically collected from participants in the T3 treatment group. This data may include subjective reports, clinical assessments, and laboratory analyses.', 'interventionNames': ['Dietary Supplement: Zingier officinale powder']}, {'type': 'EXPERIMENTAL', 'label': 'T3', 'description': '* Carum carvi, L, commonly known as caraway, is a botanical with a rich history of traditional use. In this clinical study, a treatment group, denoted as T3, is established to investigate the effects of encapsulated Carum carvi, L powder in alleviating the gastrointestinal disturbances among TB patients.\n* Intervention Details:\n\n * Generic Name: Carum carvi, L powder\n * Dosage Form: Encapsulated\n * Dosage: 1 g per capsule\n * Frequency: Twice daily\n * Total Daily Dosage: 2 g/day\n * Administration Timing: After breakfast and dinner\n * Duration of Treatment: 3 months\n* Throughout the study duration, data will be systematically collected from participants in the T3 treatment group. This data may include subjective reports, clinical assessments, and laboratory analyses.', 'interventionNames': ['Dietary Supplement: Carum carvi, L powder']}, {'type': 'EXPERIMENTAL', 'label': 'T4', 'description': '* Mentha spicata L, commonly known as spearmint, is renowned for its aromatic properties and potential health benefits. In this clinical study, a treatment group, designated as T4, is established to explore the effects of encapsulated Mentha spicata oil.\n* Intervention Details:\n\n * Generic Name: Mentha spicata oil\n * Dosage Form: Encapsulated\n * Concentration: 2% of Spearmint essential oil\n * Dosage: 1.5 ml per capsule\n * Frequency: Twice daily\n * Total Daily Dosage: 30 ml/day\n * Administration Timing: After breakfast and dinner\n * Duration of Treatment: 3 months\n* Throughout the study duration, data will be systematically collected from participants in the T4 treatment group. This data may include subjective reports, clinical assessments, and laboratory analyses.', 'interventionNames': ['Dietary Supplement: Mentha spicata oil']}, {'type': 'NO_INTERVENTION', 'label': 'Washout period', 'description': '* In this phase impact of withholding the intervention on all parameters will be studied.\n* All parameters included in phase1 and 2 will be repeated after one month accordingly, to observe any change in selected parameters after discontinuation of intervention.'}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'description': 'Inert Material', 'armGroupLabels': ['T1']}, {'name': 'Zingier officinale powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The raw form of Zingiber officinale will be grounded in powder by manual grinding and will be encapsulated.', 'armGroupLabels': ['T2']}, {'name': 'Carum carvi, L powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The raw form of Carum carvi, L will be grounded in powder by manual grinding and will be encapsulated.', 'armGroupLabels': ['T3']}, {'name': 'Mentha spicata oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Mentha spicata L will be extracted in the form of oil and will be encapsulated.', 'armGroupLabels': ['T4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64200', 'city': 'Rahim Yar Khan', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Sheikh Zayed Medical / college', 'geoPoint': {'lat': 28.41987, 'lon': 70.30345}}], 'overallOfficials': [{'name': 'Asma Latif, PhD Scholar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheikh Zaid Medical / college.Rahim Yar Khan.Pakistan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allama Iqbal Open University Islamabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dietician', 'investigatorFullName': 'Asma Latif', 'investigatorAffiliation': 'Allama Iqbal Open University Islamabad'}}}}