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Use of Traditional Chinese Medicine (Ren Shen Yang Rong Tang) Against Microinflammation in Hemodialysis Patients: A Quasi-randomized Controlled Trial

NCT02053740 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2014-02-04

No results posted yet for this study

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.

Conditions

  • Immune Dysfunction

Interventions

DRUG

Add R-S-Y-R-T (500 mg 3 times per day) for 6 months

DRUG

Routine western medicine

Sponsors & Collaborators

  • Tri-Service General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-08-31

Countries

  • Taiwan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02053740 on ClinicalTrials.gov