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Efficacy, Safety and Response Predictors of Adjuvant Astragalus Therapy for Diabetic Kidney Disease

NCT03535935 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2020-12-07

No results posted yet for this study

Summary

This add-on open-label randomised controlled pragmatic trial aims to:

1. evaluate the effect of add-on astragalus treatment on type 2 diabetic patients with stage 2 to 3 chronic kidney disease and macroalbuminuria.
2. estimate treatment effect, variance, recruitment rate, attrition rate and change in clinical manifestation including Chinese medicine syndrome for parameters optimisation and feasibility assessment for a subsequent phase III randomised controlled trial.
3. assess response predictors for efficacy and safety among type 2 diabetic patients with stage 2 to 3 chronic kidney disease and macroalbuminuria receiving add-on astragalus treatment

Conditions

  • Diabetic Nephropathies
  • Diabetic Kidney Disease

Interventions

DRUG

Astragalus Powder

3 grams of water soluble astragalus sachets (equivalent to 15g raw herbs) administrated orally on top of standard medical care for 48 weeks. Patients will have 5 days of medicine per week and will be advised to take the medicine once daily dissolved in boiling water in the first 5 days of the week.

OTHER

Routine medical care (active comparator)

Angiotensin converting enzyme inhibitor or angiotensin receptor blocker

Sponsors & Collaborators

  • School of Chinese Medicine, The University of Hong Kong

    collaborator UNKNOWN

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Sydney CW TANG, MD, PhD · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2022-06-30
Completion
2022-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03535935 on ClinicalTrials.gov