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Not yet recruiting NCT07657338

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

No phase Interventional Non-diabetic Chronic Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chinese herbal formula CKD-1.
Who it may be relevant to
Registry conditions: Non-diabetic Chronic Kidney Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other 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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • China Medical University Beigang Hospital — Yunlin

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗