To Evaluate the Efficacy of Eleutherococcus Senticosus for Subjects Under Renal Dialysis
Nøgleord
Abstrakt
Datoer
| Sidst bekræftet: | 03/31/2020 |
| Først indsendt: | 07/02/2017 |
| Anslået tilmelding indsendt: | 07/03/2017 |
| Først indsendt: | 07/06/2017 |
| Sidste opdatering indsendt: | 04/26/2020 |
| Sidste opdatering indsendt: | 05/05/2020 |
| Dato for første indsendte resultater: | 04/12/2020 |
| Dato for første indsendte QC-resultater: | 04/26/2020 |
| Dato for første bogførte resultater: | 05/05/2020 |
| Faktisk startdato for undersøgelsen: | 12/08/2015 |
| Anslået primær afslutningsdato: | 06/29/2017 |
| Anslået afslutningsdato for undersøgelsen: | 06/29/2017 |
Tilstand eller sygdom
Intervention / behandling
Dietary Supplement: Eleutherococcus senticosus
Other: Placebo
Fase
Armgrupper
| Arm | Intervention / behandling |
|---|---|
| Experimental: Eleutherococcus senticosus Acanthopanax senticosus-mono formula (30mg/vial) and Fructus Ziziphi Jujube concentrated juice15ml/vial | Dietary Supplement: Eleutherococcus senticosus taken orally once/day for 90 days |
| Placebo Comparator: Placebo Fructus Ziziphi Jujube concentrated juice15ml/vial | Other: Placebo taken orally once/day for 90 days |
Kriterier for støtteberettigelse
| Alder berettiget til undersøgelse | 20 Years Til 20 Years |
| Køn, der er berettiget til undersøgelse | All |
| Accepterer sunde frivillige | Ja |
| Kriterier | Inclusion Criteria: - Under regular dialysis for at least 3 months - Hemoglobin (Hb) <11 g/L after regular Erythropoietin (EPO) treatment - Subjects with written informed consent form Exclusion Criteria: - Use of steroid or high dose of antiplatelet drug (e.g. Aspirin >300mg) within one month - Had surgery, myocardial infarction, or tumor within 12 weeks - Currently use of antibiotic treatment for acute infection - Pregnant women - Reticulocyte>40 x 10^9 - Anemia (ferritin <100ng/mL and Transferrin Saturation (TSAT) <20%) - Urea reduction ratio <65% or single pool Kt/V < 1.0 (hemodialysis patients) or total weekly Kt/V<1.7 (peritoneal dialysis patients) - Sudden change of eating habit within one month - Expected life less than six months or with unstable medical conditions - Known history of allergic reaction to the investigational products - With acute diseases and judged by the investigator to be ineligible to participate - Received melatonin, androgen therapy or blood transfusion within two months - Received any trial medications within 30 days |
Resultat
Primære resultatforanstaltninger
1. Erythropoietin (EPO) [baseline and 3 months]
2. Hemoglobin (Hb) [baseline and 3 months]
Sekundære resultatforanstaltninger
1. Red Blood Cell (RBC) [baseline and 3 months]
2. Hematocrit (Hct) [baseline and 3 months]
3. Mean Corpuscular Hemoglobin Concentration (MCHC) [baseline and 3 months]
4. Mean Corpuscular Volume (MCV) [baseline and 3 months]
5. Mean Corpuscular Hemoglobin (MCH) [baseline and 3 months]
6. Intact Parathyroid Hormone (iPTH) [baseline and 3 months]
7. Tumor Necrosis Factor - Alpha (TNF-alpha) [baseline and 3 months]
8. Interleukin 6 (IL-6) [baseline and 3 months]
