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Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Chen Xiangmei, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02063100
First Posted: February 14, 2014
Last Update Posted: July 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tianjin TongRenTang Group Co., Ltd.
Information provided by (Responsible Party):
Chen Xiangmei, Chinese PLA General Hospital
  Purpose
-Evaluate the efficacy and safety of Shenyankangfu Tablets to control the proteinuria of patients with primary glomerulonephritis compare with Losartan potassium.

Condition Intervention Phase
Glomerulonephritis Proteinuria Drug: Shenyankangfu tablets Drug: Losartan potassium 50mg Drug: Shenyankangfu tablets and Losartan potassium 50mg Drug: Shenyankangfu tablets and Losartan potassium 100mg Drug: Losartan potassium 100mg Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis—a Multicentre, Prospective, Double-blind, Double-dummy, Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Chen Xiangmei, Chinese PLA General Hospital:

Primary Outcome Measures:
  • changes of 24 hours proteinuria after the treatment [ Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment ]

Secondary Outcome Measures:
  • changes of serum creatinine after treatment [ Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment ]
  • changes of eGFR after the treatment [ Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment ]
  • changes of Traditional Chinese Medicine syndrome scores after the treatment [ Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment ]

Estimated Enrollment: 720
Study Start Date: February 2014
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Shenyankangfu tablets and Losartan potassium 100mg Drug: Shenyankangfu tablets and Losartan potassium 100mg
Shenyankangfu tablets 2.4g, po, 3/day and losartan potassium 50mg×2,po, 1/day, all drugs and placebo are taken for 48 weeks.
Experimental: Shenyankangfu tablets and Losartan potassium 50mg Drug: Shenyankangfu tablets and Losartan potassium 50mg
Shenyankangfu tablets 2.4g, po, 3/day and losartan potassium 50mg,po, 1/day and losartan potassium placebo1 tab, po, 1/day, all drugs and placebo are taken for 48 weeks.
Experimental: Losartan potassium 50mg Drug: Losartan potassium 50mg
Shenyankangfu tablets placebo 5 tab, po, 3/day and losartan potassium 50mg,po, 1/day and losartan potassium placebo1 tab,po, 1/day, all drugs and placebo are taken for 48 weeks.
Experimental: Shenyankangfu tablets Drug: Shenyankangfu tablets
Shenyankangfu tablets 2.4g, po, 3/day and Losartan potassium placebo 2 tab, po, 1/day,all drugs and placebo are taken for 48 weeks.
Experimental: Losartan potassium 100mg Drug: Losartan potassium 100mg
Shenyankangfu tablets placebo 5 tab, po, 3/day and losartan potassium 50mg×2,po, 1/day, all drugs and placebo are taken for 48 weeks.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • Diagnosed with primary glomerulonephritis
  • Aged from 18 to 70 years,male or female
  • Blood pressure can be controlled ≤140/90mmHg
  • GFR≥45ml/min/1.73㎡
  • 0.5g≤24 hours proteinuria≤3.0g
  • Traditional Chinese medicine syndrome conform Qi-Yin Deficiency
  • Obtain the agreement of patients or their guardians, and signed informed consent file

Exclusion Criteria:

  • secondary nephropathy
  • Take the glucocorticoid,immunosuppressants and Tripterygium drug in the last 12 months
  • Take other Chinese patent medicine and decoction which can reduce proteinuria in the last 2 weeks
  • Take renin-angiotensin system blockers in last 4 weeks
  • Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life
  • Pregnant or lactating women
  • Allergic predisposition or known to be allergic to the drug composition
  • Blood presser <90/60mmHg
  • With unilateral or bilateral renal artery stenosis
  • With mental disorders and poor compliance
  • Be suspected or confirmed with alcohol, drug abuse history
  • Be participating in another clinical study at the same period
  Contacts and Locations
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): NCT02063100


Contacts
Contact: jie wu, doctor +86-010-66937763 wujie301@126.com
Contact: jia kou, doctor chinakoujia@163.com

  Show 43 Study Locations
Sponsors and Collaborators
Chinese PLA General Hospital
Tianjin TongRenTang Group Co., Ltd.
Investigators
Principal Investigator: xiangmei chen, Doctor State Key Laboratory of Kidney Diseases,Chinese PLA General Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chen Xiangmei, Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02063100     History of Changes
Other Study ID Numbers: S2013-055-03
First Submitted: February 12, 2014
First Posted: February 14, 2014
Last Update Posted: July 1, 2015
Last Verified: June 2015

Keywords provided by Chen Xiangmei, Chinese PLA General Hospital:
Glomerulonephritis
proteinuria
shenyankangfu tablets
Losartan Potassium
efficacy
safety

Additional relevant MeSH terms:
Proteinuria
Glomerulonephritis
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Nephritis
Kidney Diseases
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action