Ignite Creation Date:
2024-05-06 @ 2:28 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02053740
Status:
COMPLETED
Last Update Posted:
2014-02-04
First Post:
2014-01-30
Brief Title:
Use of Traditional Chinese Medicine Ren Shen Yang Rong Tang Against Microinflammation in Hemodialysis Patients A Quasi-randomized Controlled Trial
Sponsor:
Tri-Service General Hospital
Organization:
Tri-Service General Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Participants and study design
Subjects were recruited and selected for uremic patients on maintenance hemodialysis HD who informed us of their interest in the investigators study and were mentally capable to give an informed written consent and willing to comply with study requirements The inclusion criteria were 18 years or older with at least 3 months maintenance HD The exclusion criteria were malignancy acute infection gastrointestinal bleeding pregnancy and inability to comply with the requirements of study
69 respondents were enrolled in this trial A single-center quasi-randomized controlled clinical trial was designed based on the patients in the care of one attending physician Eligible subjects were allocated to study and control group and the basic characteristics between the experimental group and control group were matched There was no significant difference regarding gender aged education level comorbidities between these two groups The experimental group was treated with Ren Shen Yang Rong Tang R-S-Y-R-T combined routine western medicine and the control group was treated with WM alone The experimental group had 32 respondents and the control group had 37 respondents The duration of use of R-S-Y-R-T was 6 months Finally there were 27 patients in the experimental group and 32 patients in the control group completed the study Blood investigation including biochemical profiles and inflammatory markers were checked at intervals 0 2 4 and 6 months form routine HD The questionnaire for the assessment of quality of life QOL was evaluated at interval 0 and 6 months
Subjects were recruited and selected for uremic patients on maintenance hemodialysis HD who informed us of their interest in the investigators study and were mentally capable to give an informed written consent and willing to comply with study requirements The inclusion criteria were 18 years or older with at least 3 months maintenance HD The exclusion criteria were malignancy acute infection gastrointestinal bleeding pregnancy and inability to comply with the requirements of study
69 respondents were enrolled in this trial A single-center quasi-randomized controlled clinical trial was designed based on the patients in the care of one attending physician Eligible subjects were allocated to study and control group and the basic characteristics between the experimental group and control group were matched There was no significant difference regarding gender aged education level comorbidities between these two groups The experimental group was treated with Ren Shen Yang Rong Tang R-S-Y-R-T combined routine western medicine and the control group was treated with WM alone The experimental group had 32 respondents and the control group had 37 respondents The duration of use of R-S-Y-R-T was 6 months Finally there were 27 patients in the experimental group and 32 patients in the control group completed the study Blood investigation including biochemical profiles and inflammatory markers were checked at intervals 0 2 4 and 6 months form routine HD The questionnaire for the assessment of quality of life QOL was evaluated at interval 0 and 6 months
Detailed Description:
Study medication and dosage
For this study the investigators used herbal granules prepared according to the formula of R-S-Y-R-T The investigators purchased the study products from a manufacturer with a Good Manufacturing Practice Si Wu Tang certification in Taiwan This was a concentrated decoction made by water extraction in 113 ratio from single batched roots of the 14 plants in proportions Radix Paeoniae alba Bai Sau 90 g Radix Angelicae sinensis Dang Guay 30 g Pericarpium Citri Reticulatae Chenpi 30 g Radix Astragali Huangqi 30 g Cortex Cinnamomi Rougui 30 g Radix Ginseng Renshen 30 g Rhizoma Atractylodis Macrocephalae Baizhu 30 g Radix Glycyrrhizae Gancao 30 g Radix Rehmanniae praeparata Soe Dee Huang 20 g Fructus Schisandrae Wuweizi 20 g Poria cocos Fuling 20 g Cortex et Radix Polygalae Yuanzhi 15 g Zingiber officinale Roscoe Jiang 30 gFructus Jujubae Dazao 10 g as prepared according to the original pharmacopoeia The plant origins in China were known to the buyer of the pharmaceutical company and the final product was free of E coli Salmonella and pesticide residues The levels of heavy metals were 1238 ppm for lead 0228 ppm for arsenic010 ppm for cadmium and 00022 ppm for mercury all within regulated limits 5 5 05 and 05 ppm respectively Each pack weighed approximately 500 mg in aluminum packets
The investigators determined the dosage of 1 pack a time for 3 times a day with warm water for 6 months The exact number of packs taken was recorded in clinic visits and any unfinished packs were brought back to the study nurse at the next clinic visit
For this study the investigators used herbal granules prepared according to the formula of R-S-Y-R-T The investigators purchased the study products from a manufacturer with a Good Manufacturing Practice Si Wu Tang certification in Taiwan This was a concentrated decoction made by water extraction in 113 ratio from single batched roots of the 14 plants in proportions Radix Paeoniae alba Bai Sau 90 g Radix Angelicae sinensis Dang Guay 30 g Pericarpium Citri Reticulatae Chenpi 30 g Radix Astragali Huangqi 30 g Cortex Cinnamomi Rougui 30 g Radix Ginseng Renshen 30 g Rhizoma Atractylodis Macrocephalae Baizhu 30 g Radix Glycyrrhizae Gancao 30 g Radix Rehmanniae praeparata Soe Dee Huang 20 g Fructus Schisandrae Wuweizi 20 g Poria cocos Fuling 20 g Cortex et Radix Polygalae Yuanzhi 15 g Zingiber officinale Roscoe Jiang 30 gFructus Jujubae Dazao 10 g as prepared according to the original pharmacopoeia The plant origins in China were known to the buyer of the pharmaceutical company and the final product was free of E coli Salmonella and pesticide residues The levels of heavy metals were 1238 ppm for lead 0228 ppm for arsenic010 ppm for cadmium and 00022 ppm for mercury all within regulated limits 5 5 05 and 05 ppm respectively Each pack weighed approximately 500 mg in aluminum packets
The investigators determined the dosage of 1 pack a time for 3 times a day with warm water for 6 months The exact number of packs taken was recorded in clinic visits and any unfinished packs were brought back to the study nurse at the next clinic visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None