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Semi-individualised Chinese Medicine Treatment as an Adjuvant Management for Diabetic Nephropathy (SCHEMATIC)

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ClinicalTrials.gov Identifier: NCT02488252
Recruitment Status : Recruiting
First Posted : July 2, 2015
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
School of Chinese Medicine, The University of Hong Kong
Information provided by (Responsible Party):
Sydney CW TANG, The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathies Drug: Semi-individualised Chinese Medicine treatment Drug: Routine medical care (active comparator) Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Semi-individualised Chinese Medicine Treatment as an Adjuvant Management for Diabetic Nephropathy - A Pilot add-on, Randomised, Controlled, Multi-centre, Open-label Pragmatic Clinical Trial
Actual Study Start Date : July 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard medical care
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker and oral hypoglycemic agents or insulin at stable dose
Drug: Routine medical care (active comparator)
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker at stable dose

Experimental: Chinese Medicine on top of standard medical care

Semi-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

Drug: Semi-individualised Chinese Medicine treatment

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


Drug: Routine medical care (active comparator)
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker at stable dose




Primary Outcome Measures :
  1. Change in estimated GFR [ Time Frame: From baseline to 48 weeks after treatment ]
    Efficacy and safety

  2. Change in spot urine albumin-to-creatinine ratio [ Time Frame: From baseline to 48 weeks after treatment ]
    Efficacy and safety


Secondary Outcome Measures :
  1. Change in fasting blood glucose (FBG) [ Time Frame: From baseline to 48 weeks after treatment ]
  2. Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline to 48 weeks after treatment ]
  3. Change in urinary Cystatin C [ Time Frame: From baseline to 48 weeks after treatment ]
  4. Change in urinary nephrin [ Time Frame: From baseline to 48 weeks after treatment ]
  5. Change in serum fibroblast growth factor 23 (FGF-23) [ Time Frame: From baseline to 48 weeks after treatment ]
  6. Change in urinary monocyte chemotactic protein 1 (MCP-1) [ Time Frame: From baseline to 48 weeks after treatment ]
  7. Change in urinary transforming growth factor beta-1 (TGF-β1) [ Time Frame: From baseline to 48 weeks after treatment ]
  8. Change in urinary vascular endothelial growth factor (VEGF) [ Time Frame: From baseline to 48 weeks after treatment ]
  9. Change in serum brain natriuretic peptide (BNP) [ Time Frame: From baseline to 48 weeks after treatment ]
  10. Change in fasting serum insulin [ Time Frame: From baseline to 48 weeks after treatment ]
  11. Change in serum C-peptide [ Time Frame: From baseline to 48 weeks after treatment ]
  12. Rate of CKD stage transition [ Time Frame: From baseline to 48 weeks after treatment ]


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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488252


Contacts
Contact: Sydney CW TANG, MD, PhD +852 22553879 scwtang@hku.hk
Contact: Kam Wa CHAN, BCM, MCM, MSc.(PH) +852 22553207 chriskwcchan@hku.hk

Locations
Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Sydney CW TANG, MD, PhD    +852 22553879    scwtang@hku.hk   
Contact: Kam Wa CHAN, BCM, MCM, MSc.(PH)    +852 22553207    chriskwcchan@hku.hk   
Sub-Investigator: YB FENG, PhD         
Sponsors and Collaborators
The University of Hong Kong
School of Chinese Medicine, The University of Hong Kong
Investigators
Principal Investigator: Sydney CW TANG, MD, PhD The University of Hong Kong

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sydney CW TANG, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02488252     History of Changes
Other Study ID Numbers: DN-CM-1
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018

Keywords provided by Sydney CW TANG, The University of Hong Kong:
Chinese Medicine
ACEI
ARB
Pragmatic trial

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors