Immune Dysfunction Clinical Trial
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.
Status | Completed |
Enrollment | 59 |
Est. completion date | |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - More than 18 years or older - With maintenance HD for at least 3 months Exclusion Criteria: - Malignancy - Acute infection - Gastrointestinal bleeding - Pregnancy - Inability to comply with the requirements of study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Taiwan | Tri-service general hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Tri-Service General Hospital |
Taiwan,
Aoki T, Kojima T, Kameda N, Yoshijima S, Ono A, Kobayashi Y. [Anti-inflammatory effect of a traditional Chinese medicine, ren-shen-yang-rong-tang (Japanese name: ninjin-youei-to), on alveolar macrophages stimulated by RANTES or TNF-alpha]. Arerugi. 1994 May;43(5):663-7. Japanese. — View Citation
Harigai E, Nakai S, Kawakita T, Nomoto K. Combined treatment with ren-shen-yang-rong-tang (Japanese name: ninjin-youei-to) plus prednisolone on adjuvant-induced arthritis in Lewis rat. Int J Immunopharmacol. 1995 May;17(5):411-8. — View Citation
Nakai S, Kawakita T, Nagasawa H, Himeno K, Nomoto K. Thymus-dependent effects of a traditional Chinese medicine, ren-shen-yang-rong-tang (Japanese name; Ninjin-youei-to), in autoimmune MRI/MP-lpr/lpr mice. Int J Immunopharmacol. 1996 Apr;18(4):271-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inflammatory markers | These inflammatory markers include c-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-a (TNF-a). We use the xMAP serum assay for the 3 cytokines. | Average 26 weeks (6 months) | Yes |
Secondary | Quality of life | We use the Taiwan version of the WHOQOL-BREF (WHOQOL-BREF [TW]). | Average 26 weeks (6 months) | Yes |
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