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Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease

26 août 2016 mis à jour par: Chen Xiangmei
Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

1500

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Shenyan kangfu Tablets
Shenyan Kangfu Tablets；Each weighing 0.48g；Oral；Once five, three times a day
Médicament: Shenyan Kangfu Tablet
Observation period: 24 weeks. The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
24-hour urinary protein excretion
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Serum creatinine
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Routine blood test
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Chen Xiangmei

Collaborateurs

Tianjin TongRenTang Group Co., Ltd.

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2015

Achèvement primaire (Anticipé)

1 décembre 2016

Achèvement de l'étude (Anticipé)

1 décembre 2016

Dates d'inscription aux études

Première soumission

3 juin 2015

Première soumission répondant aux critères de contrôle qualité

26 août 2016

Première publication (Estimation)

1 septembre 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

1 septembre 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 août 2016

Dernière vérification

1 août 2016

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • S2015-023-02

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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