Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-05 @ 5:21 PM
Study NCT ID:
NCT03649269
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2018-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PC-300 Tea Effect on Triglyceride Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069459', 'term': 'Teas, Herbal'}, {'id': 'D001629', 'term': 'Bezafibrate'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Voluntary subjects were assigned sequentially into two treatment groups: 1) fibrate (bezafibrate) 200 mg/day, and 2) PC-300 tea, one cup half an hour before eating.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-27', 'studyFirstSubmitDate': '2018-08-24', 'studyFirstSubmitQcDate': '2018-08-27', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Triglycerides serum levels.', 'timeFrame': 'One month.', 'description': 'The triglycerides serum levels were measured at the recruiting moment and after one month..'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eryngium heterophyllum', 'Amphipterygium adstringens', 'tea'], 'conditions': ['Hypertriglyceridemia']}, 'descriptionModule': {'briefSummary': 'Herbal medicine represents an alternative for treating dyslipidemia. The aim of this project was to evaluate the PC-300 tea (Eryngium heterophyllum egelm + Amphipterygium adstringens) against hypertriglyceridemia.\n\nBaseline samples of serum total cholesterol and triglycerides were obtained and measured again after 1 month of treatment with the following two alternatives: 1) PC-300, one cup half an hour before eating, and 2) bezafibrate 200 mg/d.', 'detailedDescription': 'It was a descriptive, prospective, longitudinal, and comparative clinical study developed at Ciprés Grupo Médico S.C. (CGM), Toluca, Mexico, from January 2014 to December 2014.\n\nPatients with hypertriglyceridemia were invited to participate in the study. Voluntary subjects were assigned sequentially into two treatment groups: 1) fibrate (bezafibrate) 200 mg/day, and 2) PC-300 tea, one cup half an hour before eating.\n\nPatients were measured (m) and weighed (kg) (Obi, México). Body mass index (BMI) was calculated as weight (kg) divided by height (m) squared. Blood pressure was measured with a calibrated sphygmomanometer (Welch Allyn, USA) after 5 min of rest.\n\nAll of the patients were given a low lipid diet. Calculated kcal were based on ideal weight minus 200 kcal/day if overweight.\n\nResults were expressed as mean ± Standard deviation (SD). Differences between initial vs. final values were compared with the Mann-Whitney U test. The normality hypothesis was tested using the Kolmogorov-Smirnov test. A p value of \\<0.05 was considered significant. All tests were performed with the SPSS ver. 23 statistical software program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with hypertriglyceridemia, aged \\>18 years and with an educational level at least of primary school.\n\nExclusion Criteria:\n\n* Patients with hepatic disease and those missing an appointment during the study.'}, 'identificationModule': {'nctId': 'NCT03649269', 'briefTitle': 'PC-300 Tea Effect on Triglyceride Levels', 'organization': {'class': 'OTHER', 'fullName': 'Ciprés Grupo Médico CGM SC'}, 'officialTitle': 'Eryngium Heterophyllum + Amphipterygium Adstringens Tea Effect on Triglyceride Levels', 'orgStudyIdInfo': {'id': '2014/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PC-300 tea', 'description': 'Patients that received the Eryngium heterophyllum + Amphipterygium adstringens tea, one cup half an hour before eating.', 'interventionNames': ['Dietary Supplement: PC-300 tea.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bezafibrate', 'description': 'Patients that received fibrate (bezafibrate) 200 mg/day.', 'interventionNames': ['Drug: Bezafibrate']}], 'interventions': [{'name': 'PC-300 tea.', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Herbal tea'], 'description': 'Patients had to drink one cup of the tea half an hour before breakfast, main meal and dinner.', 'armGroupLabels': ['PC-300 tea']}, {'name': 'Bezafibrate', 'type': 'DRUG', 'otherNames': ['Bezalip'], 'description': 'Patients were prescribed 200 mg/day at night.', 'armGroupLabels': ['Bezafibrate']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hugo Mendieta Zerón, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ciprés Grupo Médico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'With this first study researcher are not planning to share the IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ciprés Grupo Médico CGM SC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}