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Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease

26. august 2016 opdateret af: Chen Xiangmei
Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Research purpose: Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.

The crowd: patients with primary glomerular nephritis, diabetic nephropathy patients.

Study design: a multicenter clinical study design, openness. The study drug: Shenyan Kangfu Tablets. Statistical analysis: Research plan is determined, by statistical professionals responsible for negotiation with the principal investigator for statistical analysis plan.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

1500

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina
        • Rekruttering
        • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
      • Beijing, Beijing, Kina, 100853
        • Rekruttering
        • National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital
        • Kontakt:
        • Ledende efterforsker:
          • xiangmei chen, doctor
    • Chongqing
      • Chongqing, Chongqing, Kina
        • Rekruttering
        • Daping Hospital,Research Institute of Surgery Third Military Medical University
    • Fujian
      • Fuzhou, Fujian, Kina
        • Rekruttering
        • Fuzhou General Hospital Nanjing Military Command
      • Xiamen, Fujian, Kina
        • Rekruttering
        • 174th hospital of the People's Liberation Army
    • Hebei
      • Qinhuangdao, Hebei, Kina
        • Rekruttering
        • Beidaihe Sanatorium of Beijing Military Mrca
    • Heilongjiang
      • Harbin, Heilongjiang, Kina
        • Rekruttering
        • Heilongjiang University of Chinese Medicine
    • Henan
      • Zhengzhou, Henan, Kina
        • Rekruttering
        • Henan Provincial People's Hospital
    • Shandong
      • Jinan, Shandong, Kina
        • Rekruttering
        • Shandong Province Hospital
    • Shanghai
      • Shanghai, Shanghai, Kina
        • Rekruttering
        • Changhai Hospital of Shanghai
      • Shanghai, Shanghai, Kina
        • Rekruttering
        • LONGHUA Hospital Shanghai University of TCM
    • Shanxi
      • Taiyuan, Shanxi, Kina
        • Rekruttering
        • First Hospital of Shanxi Medical University
    • Tianjin
      • Tianjin, Tianjin, Kina
        • Rekruttering
        • First Teaching Hospital of Tianjin University of TCM

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Diagnosed with primary glomerulonephritis or diabetic nephropathy;
  2. Aged from 18 to 70 years，male or female
  3. GFR≥45ml/min/1.73㎡
  4. 0.5g≤24 hours proteinuria≤3.0g
  5. glycated hemoglobin (HbAlc) ≤8% (This has been limited to patients with diabetic nephropathy)
  6. Traditional Chinese medicine syndrome conform Qi-Yin Deficiency
  7. Obtain the agreement of patients or their guardians, and signed informed consent file

Exclusion Criteria:

  1. Secondary nephropathy
  2. People allergic to Shenyankangfu tables
  3. Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life
  4. Pregnant or lactating women
  5. Be participating in another clinical study at the same period

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Shenyan kangfu Tablets
Shenyan Kangfu Tablets；Each weighing 0.48g；Oral；Once five, three times a day
Medicin: Shenyan Kangfu Tablet
Observation period: 24 weeks. The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
24-hour urinary protein excretion
Tidsramme: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum creatinine
Tidsramme: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Glomerular filtration rate
Tidsramme: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Albumin
Tidsramme: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Glycated hemoglobin
Tidsramme: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
Observations of the project value and the percentage change in value before and after the treatment.
Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
Symptom scores
Tidsramme: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Routine blood test
Tidsramme: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Routine urine test
Tidsramme: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Liver function
Tidsramme: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Renal function tests
Tidsramme: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Potassium detection
Tidsramme: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
blood glucose testing
Tidsramme: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Electrocardiograph
Tidsramme: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
chest radiography
Tidsramme: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
Adverse events / adverse reactions
Tidsramme: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
Follow-up 3 times.Subject at any time to contact your doctor.
Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chen Xiangmei

Samarbejdspartnere

Tianjin TongRenTang Group Co., Ltd.

Efterforskere

  • Ledende efterforsker: YongLi Zhan, investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
  • Ledende efterforsker: HongTao Yang, investigator, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  • Ledende efterforsker: Meng Liang, investigator, 174th hospital of the People's Liberation Army
  • Ledende efterforsker: Lu Ma, investigator, Beidaihe Sanatorium of Beijing Military Mrca
  • Ledende efterforsker: LiQun Song, investigator, Heilongjiang University of Chinese Medicine
  • Ledende efterforsker: QiaoLing Zhou, investigator, Xiangya Hospital of Central South University
  • Ledende efterforsker: Ping Luo, investigator, Second Hospital of Jilin University
  • Ledende efterforsker: RongShan Li, investigator, Shanxi provincial peple's hospital
  • Ledende efterforsker: XiaoHong Cheng, investigator, Shaanxi Traditional Chinese Medicine Hospital
  • Ledende efterforsker: Jie Wu, investigator, Chinese PLA General Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2015

Primær færdiggørelse (Forventet)

1. december 2016

Studieafslutning (Forventet)

1. december 2016

Datoer for studieregistrering

Først indsendt

3. juni 2015

Først indsendt, der opfyldte QC-kriterier

26. august 2016

Først opslået (Skøn)

1. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. september 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • S2015-023-02

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