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Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease

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

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

1500

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
24-hour urinary protein excretion
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Serum creatinine
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Routine blood test
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Chen Xiangmei

Samarbetspartners

Tianjin TongRenTang Group Co., Ltd.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juni 2015

Primärt slutförande (Förväntat)

1 december 2016

Avslutad studie (Förväntat)

1 december 2016

Studieregistreringsdatum

Först inskickad

3 juni 2015

Först inskickad som uppfyllde QC-kriterierna

26 augusti 2016

Första postat (Uppskatta)

1 september 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

1 september 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 augusti 2016

Senast verifierad

1 augusti 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • S2015-023-02

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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