Semi-individualised Chinese Medicine Treatment as an Adjuvant Management for Diabetic Nephropathy
SCHEMATIC
1 other identifier
interventional
148
1 country
1
Brief Summary
This study aims to explore the effect of an adjuvant semi-individualized Chinese medicine treatment plan on type 2 diabetic patients with stages 2 to 3 chronic kidney disease and macroalbuminuria. This study will collect preliminary data on treatment effect, variance, recruitment rate and attrition rate for the planning of a subsequent clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2015
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedApril 30, 2021
April 1, 2021
5.7 years
June 25, 2015
April 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in estimated GFR
Efficacy and safety
From baseline to 48 weeks after treatment
Change in spot urine albumin-to-creatinine ratio
Efficacy and safety
From baseline to 48 weeks after treatment
Secondary Outcomes (12)
Change in fasting blood glucose (FBG)
From baseline to 48 weeks after treatment
Change in glycated haemoglobin (HbA1c)
From baseline to 48 weeks after treatment
Change in urinary Cystatin C
From baseline to 48 weeks after treatment
Change in urinary nephrin
From baseline to 48 weeks after treatment
Change in serum fibroblast growth factor 23 (FGF-23)
From baseline to 48 weeks after treatment
- +7 more secondary outcomes
Study Arms (2)
Standard medical care
ACTIVE COMPARATORAngiotensin converting enzyme inhibitor or angiotensin receptor blocker and oral hypoglycemic agents or insulin at stable dose
Chinese Medicine on top of standard medical care
EXPERIMENTALSemi-individualised Chinese Medicine treatment on top of standard medical care The treatment plan consists of 5 different formulas and will be prescribed to patients categorised to 5 subgroups according to clinical manifestation. Patients having multiple manifestations that fit more than 1 subgroup will not be included. Minor adjustment of the medication will be allowed and determined by the Chinese Medicine practitioner to reflect actual clinical practice. Dosage will follow strictly the China Pharmacopeia. A: spleen and kidney Qi deficiency, B: spleen and kidney Yang deficiency, C: spleen and kidney Qi and Ying deficiency, D: liver and kidney Ying deficiency, E: Ying and Yang deficiency Rehmannia-6 decoction: Wolfiporia cocos, Rehmannia glutinosa, Common macrocarpium Fruit, Dioscorea opposita , Paeonia suffruticosa Andr., Oriental waterplantain rhizome Rehmannia-8 decoction: Radix Aconiti Lateralis preparata, Cinnamomum cassia Presl, Rehmannia-6 decoction
Interventions
A: Panax ginseng, Atractylodes macrocephala, Pinellia ternate, Pericarpium citri reticulatae, Herba Pogostemonis, Glycyrrhiza uralensis, Rehmannia-6 decoction B: Cortex magnoliae officinalis, Atractylodes macrocephala, Common Floweringquince Fruit, Common Vladimiria Root, Tsaoko Amomum Fruit, Palmae Fruit, Radixaconiti laterlis perparata, Zingiber officinale Rosc., Glycyrrhiza uralensis, Rehmannia-8 decoction C: Root of Pilose Asiabell, Astragalus membranaceus, Rehmannia glutinosa, Common Macrocarpium Fruit, Dioscorea opposita , Barbary Wolfberry Fruit, Cortex eucommiae, Chinese Angelica, Glycyrrhiza uralensis D: Rehmannia-6 decoction, Fructus Ligustri Lucidi, Yerbadetajo Herb E: Rehmannia-8 decoction, Fructus Ligustri Lucidi, Yerbadetajo Herb
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker at stable dose
Eligibility Criteria
You may qualify if:
- diagnosed with type 2 diabetes for at least 5 years;
- with an estimated glomerular filtration rate (GFR) ≥30 ˂90 mL/min/1.73m2 confirmed with repeat testing over three or more months calculated by the abbreviated MDRD study equation;
- persistent macroalbuminuria with spot urine albumin-to-creatinine ratio (UACR) ≥ 300 mg/g confirmed by at least 2 out of 3 consecutive first morning void urine samples;
- on stable dose of anti-diabetic drug including insulin for 12 weeks;
- on stable dose of angiotensin-converting-enzyme inhibitor or angiotensin receptor blocker for 12 weeks; and
- willing and able to give written informed consent
You may not qualify if:
- with known history of glomerulonephritis, polycystic kidney disease, systemic lupus erythematosus, any suggestive evidence of nondiabetic glomerulopathy;
- with known history of kidney transplant;
- with concurrent severe disorders of heart, brain, liver, and hematopoietic system, tumor and mental disorder;
- with deranged liver function;
- poorly controlled blood pressure;
- with known history of intolerance or malabsorption of oral medications;
- with uncontrollable urinary infection;
- experiencing pregnancy; or
- participating in other clinical trial within 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Mary Hospital
Hong Kong, Hong Kong
Related Publications (2)
Chan KW, Kwong ASK, Tan KCB, Lui SL, Chan GCW, Ip TP, Yiu WH, Cowling BJ, Taam Wong V, Lao L, Feng Y, Lai KN, Tang SCW. Add-on Rehmannia-6-Based Chinese Medicine in Type 2 Diabetes and CKD: A Multicenter Randomized Controlled Trial. Clin J Am Soc Nephrol. 2023 Sep 1;18(9):1163-1174. doi: 10.2215/CJN.0000000000000199. Epub 2023 Jun 12.
PMID: 37307005DERIVEDChan KW, Ip TP, Kwong AS, Lui SL, Chan GC, Cowling BJ, Yiu WH, Wong DW, Liu Y, Feng Y, Tan KC, Chan LY, Leung JC, Lai KN, Tang SC. Semi-individualised Chinese medicine treatment as an adjuvant management for diabetic nephropathy: a pilot add-on, randomised, controlled, multicentre, open-label pragmatic clinical trial. BMJ Open. 2016 Aug 5;6(8):e010741. doi: 10.1136/bmjopen-2015-010741.
PMID: 27496229DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sydney CW TANG, MD, PhD
The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 25, 2015
First Posted
July 2, 2015
Study Start
July 1, 2015
Primary Completion
March 1, 2021
Study Completion
September 1, 2021
Last Updated
April 30, 2021
Record last verified: 2021-04