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

NCT02053740 | Completed Phase 4

• 1 other identifier: TSGH 2012-1
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Dysfunction

Outcome Measures

Primary Outcomes (1)

• Inflammatory markers

  These inflammatory markers include c-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α). We use the xMAP serum assay for the 3 cytokines.

  Average 26 weeks (6 months)

Secondary Outcomes (1)

• Quality of life

  Average 26 weeks (6 months)

Study Arms (2)

R-S-Y-R-T

EXPERIMENTAL

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

Drug: Add R-S-Y-R-T (500 mg 3 times per day) for 6 months; Drug: Routine western medicine

Routine western medicine

OTHER

We kept routine western medicine only (as control group)

Drug: Routine western medicine

Interventions

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

R-S-Y-R-T

Routine western medicine DRUG

R-S-Y-R-T; Routine western medicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• More than 18 years or older
• With maintenance HD for at least 3 months

You may not qualify if:

• Malignancy
• Acute infection
• Gastrointestinal bleeding
• Pregnancy
• Inability to comply with the requirements of study

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-service general hospital

Taipei, Taipei, Taiwan

Location

Related Publications (3)

• 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. doi: 10.1016/0192-0561(96)84507-3.

  PMID: 8894807 BACKGROUND

• 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. doi: 10.1016/0192-0561(95)00018-w.

  PMID: 7591365 BACKGROUND

• 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.

  PMID: 7518231 BACKGROUND

MeSH Terms

Conditions

Immune System Diseases

Interventions

WW Domain-Containing Oxidoreductase

Intervention Hierarchy (Ancestors)

Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Nephrology

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 4, 2014
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Last Updated: February 4, 2014

Record last verified: 2014-01

Locations

TW (1)