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drugset / Trial / NCT02194946

Chinese Medicine on Deferring Dialysis Initiation

NCT02194946 ↗

Phase 1/2 Unknown 875 enrolled Guangdong Provincial Hospital of Traditional Chinese Medicine Ministry of Science and Technology of the People´s Republic of China · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Stage 5 chronic kidney disease (CKD), also end stage renal disease(ESRD), usually presents overt clinical symptoms and is a critical stage when patients are encountered with dialysis. The optimal time to initiating dialysis in patients with stage 5 CKD is addressed as the most important dialysis-related question. As indicated by the recently published European Renal Best Practice (ERBP) guideline, early initiation seemed to produce no benefit but greater expenditure and sometimes more harm.Renal replacement therapies (RRT) including dialysis are the most common procedures for patients with end-stage renal disease (ESRD), but conservative management should be an option in patients who still experience the stable period without clinical indications of dialysis.Chinese Medicine (CM) is recognized as an alternative therapy on alleviating uremic symptoms, deferring dialysis initiation, and improving quality of life. Although the effects of CM on kidney disease have been demonstrated in animal experiments, evidence from large clinical trial is insufficient. So we raise the hypothesis that CM therapies including Chinese herbal formula, Chinese patent medicine via oral pattern and/or Colonic administration, will defer the initiation of dialysis in adults with stage 5 CKD.

Timeline

Start
2014-07
Primary completion
2020-12
Completion
2020-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Berberine Traditional medicine (herbal / TCM) — Oral
Subject Calcined Concha Osterae Unknown — Other
Subject Fructus Amomi Unknown — Oral
Subject Fructus Ligustri Lucidi Unknown — Oral
Subject Herba Agastaches Unknown — Oral
Subject Herba Cistanches Unknown — Oral
Subject Herba Epimedii Unknown — Oral
Subject Herba Taraxaci Unknown — Other
Subject Poria Unknown — Oral
Subject Radix Astragali Unknown — Oral
Subject Radix Codonopsis Unknown — Oral
Subject Radix Morindae Officinalis Unknown — Oral
Subject Radix Salviae Miltiorrhizae Unknown — Oral
Subject Radix et Rhizoma Rhei Unknown — Oral
Subject Radix et Rhizoma Rhei Unknown — Other
Subject Rhizoma Atractylodis Macrocephalae Unknown — Oral
Subject Rhizoma Polygonati Unknown — Oral
Subject Rhizoma diosscoreae Unknown — Oral
Subject Semen Coicis Unknown — Oral
Subject Semen Cuscutae Unknown — Oral
Subject stir-baked Semen Persicae Unknown — Oral

Indications

end stage renal failure