{"id":"95501446-1f6e-5940-9fe2-71b68a13dd09","stable_key":"7484635e-cc8f-5cd6-a978-6dc5775a7db5:berberine-cyclosporine-null-arm","predicate":"no_significant_change_in_other_regimen","statement":"The separate 6 mg/kg cyclosporine arm found no significant pharmacokinetic change after repeated berberine.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"context_dependent","is_public":true,"mechanism_event_id":"e91a9532-60f5-5697-8949-f01dbaef7b88","mechanism_event_label":"Both outcomes remain visible with their distinct dosing conditions.","subject":{"id":"7bbe0633-b2f1-510f-adc0-3c4d0ddad05d","slug":"berberine","display_name":"Berberine","entity_type_key":"small_molecule"},"object":{"id":"e1c59346-f4ae-5904-9c57-be5fba7dcc08","slug":"cyclosporine-plasma-exposure","display_name":"Blood cyclosporine exposure","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"e91a9532-60f5-5697-8949-f01dbaef7b88","stable_key":"7484635e-cc8f-5cd6-a978-6dc5775a7db5:berberine-cyclosporine-null-arm-event","event_type":"observed_intervention","label":"Both outcomes remain visible with their distinct dosing conditions.","description":"The separate 6 mg/kg cyclosporine arm found no significant pharmacokinetic change after repeated berberine.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"2027fc88-2559-5b27-ad81-c5781ba5e00e","slug":"cyclosporine-a","display_name":"Cyclosporine A / ciclosporin A","entity_type_key":"small_molecule"},"role":"measured_drug","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"7bbe0633-b2f1-510f-adc0-3c4d0ddad05d","slug":"berberine","display_name":"Berberine","entity_type_key":"small_molecule"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""},{"entity":{"id":"e1c59346-f4ae-5904-9c57-be5fba7dcc08","slug":"cyclosporine-plasma-exposure","display_name":"Blood cyclosporine exposure","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":2,"notes":""}]},"contexts":[{"dimension":"evidence_span","value_text":"{\"source_cache\": \"artifacts/berberine-research/16541194.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"1e1c8258a18a8214a1124f3624eff9cb67151c5f54393ff2e3e7322b3bdf53b5\", \"start_char\": 0, \"end_char\": 1615, \"text_sha256\": \"1e1c8258a18a8214a1124f3624eff9cb67151c5f54393ff2e3e7322b3bdf53b5\"}","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Two small healthy-volunteer pharmacokinetic experiments","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"3 mg/kg cyclosporine with a single 0.3 g berberine dose; separate 6 mg/kg cyclosporine after 10 days of berberine","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Different cyclosporine doses and berberine schedules limit direct comparison. A null arm does not negate the positive arm or transplant finding.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Berberine research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"berberine","display_name":"Berberine","entity_type_key":"small_molecule"}},{"dimension":"organism","value_text":"Two groups of six healthy male volunteers","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"Both outcomes remain visible with their distinct dosing conditions.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[berberine-p16541194] The effects of berberine on the pharmacokinetics of cyclosporin A in healthy volunteers. (2006). https://pubmed.ncbi.nlm.nih.gov/16541194/ DOI: 10.1358/mf.2006.28.1.962774","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue_or_cell_type","value_text":"Cyclosporine pharmacokinetics","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"8553898e-120f-5a10-a0a7-e1beeaae19c0","evidence_kind":"source_excerpt","locator":"Lines 753-764","start_line":753,"end_line":764,"excerpt":"### berberine-cyclosporine-null-arm\nThe separate 6 mg/kg cyclosporine arm found no significant pharmacokinetic change after repeated berberine.\nCondition category: normal\nnutrient_topic: Berberine research collection; topical membership is not evidence of a direct dietary effect.\nplain_language: Both outcomes remain visible with their distinct dosing conditions.\norganism: Two groups of six healthy male volunteers\ntissue_or_cell_type: Cyclosporine pharmacokinetics\nexperimental_model: Two small healthy-volunteer pharmacokinetic experiments\nlimitations: Different cyclosporine doses and berberine schedules limit direct comparison. A null arm does not negate the positive arm or transplant finding.\nexposure: 3 mg/kg cyclosporine with a single 0.3 g berberine dose; separate 6 mg/kg cyclosporine after 10 days of berberine\nevidence_span: {\"source_cache\": \"artifacts/berberine-research/16541194.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"1e1c8258a18a8214a1124f3624eff9cb67151c5f54393ff2e3e7322b3bdf53b5\", \"start_char\": 0, \"end_char\": 1615, \"text_sha256\": \"1e1c8258a18a8214a1124f3624eff9cb67151c5f54393ff2e3e7322b3bdf53b5\"}\n[berberine-p16541194] The effects of berberine on the pharmacokinetics of cyclosporin A in healthy volunteers. (2006). https://pubmed.ncbi.nlm.nih.gov/16541194/ DOI: 10.1358/mf.2006.28.1.962774","model_system":"Two small healthy-volunteer pharmacokinetic experiments","directness":"author_interpretation","verification_status":"source_derived_draft","notes":"Exact curation-document quotation, not publisher quotation. Study references: [berberine-p16541194] The effects of berberine on the pharmacokinetics of cyclosporin A in healthy volunteers. (2006). https://pubmed.ncbi.nlm.nih.gov/16541194/ DOI: 10.1358/mf.2006.28.1.962774","relationship":"supports","weight":1.0,"link_notes":"","source":{"id":"9bb61e1d-e5cf-5b05-a9ca-409291f7a313","stable_key":"import-7484635e-cc8f-5cd6-a978-6dc5775a7db5","title":"Berberine: metabolism, nutrient connections and drug interactions (2026-09-17)","document_type":"imported_text","citation_label":"AI-assisted literature curation; primary study URLs and scope retained in the document and extraction. 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