Effect of Chinese Herbal Medicine on Kidney Function in Non-Diabetic CKD

Официальное название

Effects of Chinese Herbal Medicine as an Adjunctive Therapy on Renal Function in Patients With Non-Diabetic Chronic Kidney Disease: A Pilot Randomized Controlled Trial

Обзор

This study is a randomized controlled pilot trial designed to evaluate the effects and safety of a traditional Chinese medicine formula (CKD-1) as an add-on therapy to standard treatment in patients with stage 3-4 non-diabetic chronic kidney disease. Eligible participants will be randomly assigned to receive either standard care alone or standard care combined with CKD-1 for 12 weeks. Kidney function, urine protein levels, and quality of life will be assessed before and after the intervention. The study aims to provide preliminary evidence on whether CKD-1 can improve renal function and quality of life in this patient population.

Подробное описание

This study is a prospective, single-blind (data analyst-blinded), randomized controlled pilot trial evaluating a traditional Chinese medicine formula (CKD-1) as adjunctive therapy in patients with stage 3-4 non-diabetic chronic kidney disease. Chronic kidney disease is a progressive condition with limited treatment options to slow renal deterioration. Traditional Chinese medicine is widely used as a complementary approach, but clinical evidence remains limited. This trial is designed to provide preliminary clinical evidence on the potential role of CKD-1 in improving renal outcomes and supporting future large-scale randomized controlled trials.

Вмешательства

• Другое Chinese herbal formula CKD-1
  CKD-1 is a traditional Chinese herbal formula administered orally at a total daily dose of 13.5 g for 12 weeks. The formula consists of Astragalus membranaceus (3.0 g), Salvia miltiorrhiza (2.5 g), Poria cocos (2.0 g), Moutan cortex (1.5 g), Scutellaria baicalensis (1.5 g), Lonicera japonica (1.5 g), and Alisma orientale (1.5 g). It is used as an adjunct to standard care in patients with stage 3-4 non-diabetic chronic kidney disease.

Первичные конечные точки

• Change in Estimated Glomerular Filtration Rate (eGFR) [Срок оценки: From baseline to 12 weeks of treatment]

Критерии участия

Критерии включения

• Adults aged ≥18 years.
• Patients diagnosed with stage 3-4 chronic kidney disease (CKD), confirmed by a nephrologist and classified as ICD-10-CM codes N18.3-N18.4.
• Ability to understand the study procedures and provide written informed consent.
• Willingness to comply with study procedures and follow-up visits.

Критерии исключения

• Acute kidney injury or major kidney-related surgery within 3 months prior to enrollment.
• Participation in another clinical trial within 3 months that may affect renal function.
• Alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal.
• Pregnancy or breastfeeding.
• History of diabetes mellitus.
• Malignancy currently receiving chemotherapy, radiotherapy, or other systemic anticancer treatment.
• End-stage disease defined under palliative care regulations.
• Known allergy to any components of the CKD-1 herbal formula, including Astragalus membranaceus, Salvia miltiorrhiza, Poria cocos, Moutan cortex, Scutellaria baicalensis, Lonicera japonica, or Alisma orientale.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• China Medical University Beigang Hospital — Yunlin

Идентификаторы

NCT: NCT07657338 · CMUH115-REC3-058 · CMUBH-TCM-CKD-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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