Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease
26. august 2016 oppdatert av: Chen Xiangmei
Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
1500
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Beijing
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Beijing, Beijing, Kina
- Rekruttering
- Guang'anmen Hospital, China Academy of Chinese Medical Sciences
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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
-
Ta kontakt med:
- jie wu, doctor
- E-post: wujie301@163.com
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Hovedetterforsker:
- xiangmei chen, doctor
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Chongqing
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Chongqing, Chongqing, Kina
- Rekruttering
- Daping Hospital,Research Institute of Surgery Third Military Medical University
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Fujian
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Fuzhou, Fujian, Kina
- Rekruttering
- Fuzhou General Hospital Nanjing Military Command
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Xiamen, Fujian, Kina
- Rekruttering
- 174th hospital of the People's Liberation Army
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Hebei
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Qinhuangdao, Hebei, Kina
- Rekruttering
- Beidaihe Sanatorium of Beijing Military Mrca
-
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Heilongjiang
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Harbin, Heilongjiang, Kina
- Rekruttering
- Heilongjiang University of Chinese Medicine
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Henan
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Zhengzhou, Henan, Kina
- Rekruttering
- Henan Provincial People's Hospital
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Shandong
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Jinan, Shandong, Kina
- Rekruttering
- Shandong Province Hospital
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Shanghai
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Shanghai, Shanghai, Kina
- Rekruttering
- Changhai Hospital of Shanghai
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Shanghai, Shanghai, Kina
- Rekruttering
- LONGHUA Hospital Shanghai University of TCM
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Shanxi
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Taiyuan, Shanxi, Kina
- Rekruttering
- First Hospital of Shanxi Medical University
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Tianjin
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Tianjin, Tianjin, Kina
- Rekruttering
- First Teaching Hospital of Tianjin University of TCM
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Diagnosed with primary glomerulonephritis or diabetic nephropathy;
- Aged from 18 to 70 years，male or female
- GFR≥45ml/min/1.73㎡
- 0.5g≤24 hours proteinuria≤3.0g
- glycated hemoglobin (HbAlc) ≤8% (This has been limited to patients with diabetic nephropathy)
- 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
- People allergic to Shenyankangfu tables
- 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
- Be participating in another clinical study at the same period
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Shenyan kangfu Tablets
Shenyan Kangfu Tablets；Each weighing 0.48g；Oral；Once five, three times a day
|
Observation period: 24 weeks.
The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner.
|
Hva måler studien?
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 |
Tiltaksbeskrivelse |
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
|
|
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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
|
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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 |
Tiltaksbeskrivelse |
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
|
|
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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
|
|
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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
|
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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
|
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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.
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Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: YongLi Zhan, investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Hovedetterforsker: HongTao Yang, investigator, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Hovedetterforsker: Meng Liang, investigator, 174th hospital of the People's Liberation Army
- Hovedetterforsker: Lu Ma, investigator, Beidaihe Sanatorium of Beijing Military Mrca
- Hovedetterforsker: LiQun Song, investigator, Heilongjiang University of Chinese Medicine
- Hovedetterforsker: QiaoLing Zhou, investigator, Xiangya Hospital of Central South University
- Hovedetterforsker: Ping Luo, investigator, Second Hospital of Jilin University
- Hovedetterforsker: RongShan Li, investigator, Shanxi provincial peple's hospital
- Hovedetterforsker: XiaoHong Cheng, investigator, Shaanxi Traditional Chinese Medicine Hospital
- Hovedetterforsker: Jie Wu, investigator, Chinese PLA General Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2015
Primær fullføring (Forventet)
1. desember 2016
Studiet fullført (Forventet)
1. desember 2016
Datoer for studieregistrering
Først innsendt
3. juni 2015
Først innsendt som oppfylte QC-kriteriene
26. august 2016
Først lagt ut (Anslag)
1. september 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
1. september 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. august 2016
Sist bekreftet
1. august 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- S2015-023-02
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