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Open Access Study protocol

Chinese medicine combined with calcipotriol betamethasone and calcipotriol ointment for Psoriasis vulgaris (CMCBCOP): study protocol for a randomized controlled trial

Ze-Huai Wen12, Mei-Ling Xuan1, Yu-Hong Yan3, Xiao-Yan Li1, Dan-Ni Yao3, Geng Li1, Xin-Feng Guo1, Ai-Hua Ou1 and Chuan-Jian Lu3*

Author Affiliations

1 Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, 111 Dade Road, Guangzhou 510120, China

2 National Centre for Design Measurement and Evaluation in Clinical Research, Guangzhou University of Chinese Medicine, 12 Jichang Road, Guangzhou 510405, China

3 Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, 111 Dade Road, Guangzhou 510120, China

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Trials 2014, 15:294  doi:10.1186/1745-6215-15-294

Published: 22 July 2014

Abstract

Background

Psoriasis causes worldwide concern because of its high-prevalence, as well as its harmful, and incurable characteristics. Topical therapy is a conventional treatment for psoriasis vulgaris. Chinese medicine (CM) has been commonly used in an integrative way for psoriasis patients for many years. Some CM therapies have shown therapeutic effects for psoriasis vulgaris (PV), including relieving symptoms and improving quality of life, and may reduce the relapse rate. However, explicit evidence has not yet been obtained. The purpose of the present trial is to examine the efficacy and safety of the YXBCM01 granule, a compound Chinese herbal medicine, with a combination of topical therapy for PV patients.

Methods/Design

Using an add-on design, the trial is to evaluate whether the YXBCM01 granule combined topical therapy is more effective than topical therapy alone for the treatment of PV. The study design is a double-blind, parallel, randomized controlled trial comparing the YXBCM01 granule (5.5 g twice daily) to a placebo. The duration of treatment is 12 weeks. A total of 600 participants will be randomly allocated into two groups, YXBCM01 granule group and placebo group, from 11 general or dermatological hospitals in China. Topical use of calcipotriol betamethasone for the first 4 weeks and calcipotriol ointment for the remaining 8 weeks will be the same standard therapy for the two groups. Patients will be enrolled if they have a clinical diagnosis of PV, a psoriasis area severe index (PASI) of more than 10 or body surface area (BSA) of more than 10%, but PASI of less than 30 and BSA of less than 30%, are aged between 18 and 65-years-old, and provide signed informed consent. The primary outcome, relapse rate, is based on PASI assessed blindly during the treatment. Secondary outcomes include: (i) relapse time interval, (ii) time to onset, (iii) rebound rate, (iv) PASI score, (v) cumulative consumption of medicine, (vi) the dermatology quality life index (DLQI), and (vii) the medical outcomes study (MOS) item short form health survey (SF-36). Analysis will be on intention-to-treat and per-protocol subject analysis principles.

Discussion

To address the effectual remission of the YXBCM01 granule for PV, this trial may provide a novel regimen for PV patients if the granule can decrease relapse rate without more adverse effects.

Trial registration

Chinese Clinical Trial Registry (http://cwww.chictr.org webcite): ChiCTR-TRC-13003233, registered 26 May 2013.

Keywords:
Psoriasis vulgaris; Randomized controlled trial; Calcipotriol Betamethasone; Calcipotriol; YXBCM01 granule; Chinese medicine