Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000493640
Ethics application status
Approved
Date submitted
5/05/2014
Date registered
12/05/2014
Date last updated
10/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Integrative medicine for plaque psoriasis combining Chinese herbal medicine with conventional therapy.
Scientific title
A feasibility study of Integrative medicine for plaque psoriasis combining Chinese herbal medicine with conventional therapy on Psoriasis Area Severity Index (PASI) score and quality of life in people with mild to moderate plaque psoriasis
Secondary ID [1] 283246 0
nil known
Universal Trial Number (UTN)
U1111-1148-1686
Trial acronym
IMPPS (Integrative Medicine for Psoriasis Pilot Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque psoriasis (psoriasis vulgaris) 290117 0
Condition category
Condition code
Alternative and Complementary Medicine 290499 290499 0 0
Herbal remedies
Skin 292165 292165 0 0
Dermatological conditions
Inflammatory and Immune System 292187 292187 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ARM 1: Chinese herbal botanical granulated extract PSORI-CM01 (YXBCM01)
packaged as 5.5g per sachet and mixed with water administered orally twice daily for 12 weeks

- Calcipotriol 0.005% (50 microgram/g) cream, (30 g tubes)
administered daily to affected body surface areas for 12 weeks according to American Academy of Dermatology (AAD) guidelines (1% surface area coverage = 0.5 fingertip units)

Both interventions to commence together.
Adherence monitored via daily patient diary and weekly assessor consultation.
Intervention code [1] 287974 0
Treatment: Drugs
Intervention code [2] 289326 0
Treatment: Other
Comparator / control treatment
- Oral granulated placebo identical in color and closest possible to taste to the Chinese herb, made from herbal starch containing no active ingredients.
packaged as 5.5g per sachet and mixed with water administered orally twice daily for 12 weeks

- Calcipotriol 0.005% (50 microgram/g) cream, (30 g tubes)
administered daily to affected body surface areas for 12 weeks according to American Academy of Dermatology (AAD) guidelines (1% surface area coverage = 0.5 fingertip units)

As per intervention for adherence and commencement.
Control group
Placebo

Outcomes
Primary outcome [1] 290519 0
change in Psoriasis Area Severity Index (PASI) score (%)
Timepoint [1] 290519 0
12 weeks and 24 weeks
Primary outcome [2] 290520 0
quality of life improvement change in Dermatology Life Quality Index (DLQI) score (%)
Timepoint [2] 290520 0
12 weeks and 24 weeks
Primary outcome [3] 290521 0
quality of life improvement change in SKINDEX 29 score
Timepoint [3] 290521 0
12 weeks and 24 weeks
Secondary outcome [1] 304706 0
adverse effects.
nausea, diarrhoea, abdominal pain assessed by patient report at assessments.
Timepoint [1] 304706 0
12 weeks and 24 weeks
Secondary outcome [2] 304707 0
relapse rate (defined as return of the rash to 50% of the area it involved before treatment)
Timepoint [2] 304707 0
24 weeks
Secondary outcome [3] 304708 0
Acceptability of treatment (measured on an ordinal scale from 0-10 where 0 equals very dissatisfied with the treatment and 10 equals very satisfied with the treatment) and willingness to repeat (measured at each assessment period on a Likert scale with a choice of response; Definitely No, Probably No, Probably yes, Definitely yes and Unsure)
Timepoint [3] 304708 0
12 and 24 weeks
Secondary outcome [4] 304709 0
Body Surface Area (BSA) score
Timepoint [4] 304709 0
12 weeks and 24 weeks
Secondary outcome [5] 304710 0
Blood test (Kidney and liver function as well as analysis of key psoriasis specific cytokine changes)
Timepoint [5] 304710 0
12 and 24 weeks
Secondary outcome [6] 304711 0
Health resource utilisation data (participant reported GP visits, hospital visits and use of medication)
Timepoint [6] 304711 0
12 weeks and 24 weeks

Eligibility
Key inclusion criteria
1 People aged between 18 years and 70 years;
2 People with at least 12 months history of psoriasis vulgaris symptoms diagnosed by physician and where calcipotriol would be appropriate treatment
3 Patient informed consent
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1 Pregnant or breast feeding females;
2 Type of psoriasis other than vulgaris;
3 PASI score >12 or <7
4 Patients taking systemic drugs or phototherapy for psoriasis within 4 weeks prior to screening;
5 Taking topical drug treatment for psoriasis within 2 weeks prior to screening
6 Other severe disorders;
7 Known disorders of calcium metabolism (high blood calcium levels);
7 Known kidney function disorders.
8 Taking calcium, vitamin D supplements or vitamin D-like medicines.
9 Known sensitivity to Chinese herbs.
10 Known sensitivity to calcipotriol
11 Unwilling/unable to cease other topical and systemic psoriasis related medication use for the duration of the trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated to intervention group (CHM plus WM) or control group (CHM placebo plus WM) in equal ratio (1:1). The randomization codes will be kept in sealed opaque envelopes and the envelopes will be opened sequentially for each participant only after participant details are written on the outside of the envelope. A number code inside the envelope will correspond with a package number that will contain 12 weeks of either real CHM granule or an identically packaged placebo granule. Neither participant nor trialists will know what package the participant has been randomised to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation numbers will be generated by computer program with sequenced blocks (blinded block number).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Baseline demographic characteristics such as gender and age will be analysed by chi square test or t test to determine equivalence between the two groups. Variables showing baseline imbalance will be taken into consideration when conducting data analysis (using the variables as covariates or performing sensitivity analysis to reveal the relationship between the variables and the outcome measures). Intention-to-treat analysis will be applied to outcome data to minimise bias due to withdrawals, all missing data will be replaced using the last observation carried forward (LOCF) method. Sensitivity analysis will be applied to measure changes to data output as a result of using the LOCF. Continuous data will be presented as means and standard deviation (SD), or 95% confidence interval (CI). Dichotomies data such as the percentage of participants achieving PASI 75 will be presented at Risk Ratio (RR) and 95% CI. P value =0.05 will be considered as statistically significant when comparing two groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/08/2014
Actual
17/03/2015
Date of last participant enrolment
Anticipated
30/11/2015
Actual
30/11/2015
Date of last data collection
Anticipated
Actual
30/04/2016
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 7368 0
3083 - Bundoora
Recruitment outside Australia
Country [1] 7278 0
China
State/province [1] 7278 0
Guangdong

Funding & Sponsors
Funding source category [1] 287984 0
University
Name [1] 287984 0
RMIT University
Country [1] 287984 0
Australia
Funding source category [2] 289185 0
University
Name [2] 289185 0
Guangdong Provincial Academy of Chinese Medical Sciences
Country [2] 289185 0
China
Primary sponsor type
University
Name
RMIT University
Address
Plenty Road, Bundoora, Victoria 3083
Country
Australia
Secondary sponsor category [1] 287856 0
None
Name [1] 287856 0
Address [1] 287856 0
Country [1] 287856 0
Other collaborator category [1] 277621 0
University
Name [1] 277621 0
Guangdong Provincial Academy of Chinese Medical Sciences
Address [1] 277621 0
106 Zhongshan 2nd Rd, Yuexiu, Guangzhou 510120
Country [1] 277621 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289913 0
RMIT University Research ethics Committee
Ethics committee address [1] 289913 0
Plenty Road Bundoora, Victoria, 3083
Ethics committee country [1] 289913 0
Australia
Date submitted for ethics approval [1] 289913 0
Approval date [1] 289913 0
02/05/2014
Ethics approval number [1] 289913 0
54/13

Summary
Brief summary
Psoriasis currently has no cure. Whilst new therapies manage severe psoriasis well mild-moderate conditions have evidence of poor management. Chinese medicine regularly treats psoriasis successfully in a clinical scenario. This study will test a previously researched herbal formula and evaluate its efficacy when integrated with standard conventional therapy (calcipotriol). The study will randomize participants to either a herbal medicine plus calcipotriol group or a placebo plus calcipotriol group and compare changes in symptom severity, quality of life and blood markers for changes after 12 weeks of the intervention. It will also assess the safety of integrating the two therapies and acceptability of the treatment as well as assess any significant difference between health resource utilization of the two groups.
Trial website
Trial related presentations / publications
Parker S, Zhang AL, Zhang CS, Goodman G, Wen Z, Lu C, Xue CC.
Oral granulated Chinese herbal medicine (YXBCM01) plus topical calcipotriol for psoriasis vulgaris: study protocol for a double-blind, randomized placebo controlled trial.
Trials. 2014 Dec 19;15:495. doi: 10.1186/1745-6215-15-495.
Public notes

Contacts
Principal investigator
Name 43054 0
Prof Charlie Xue
Address 43054 0
RMIT University
PO Box 71
Bundoora VIC, 3083
Country 43054 0
Australia
Phone 43054 0
+61 3 9925 7178
Fax 43054 0
Email 43054 0
charlie.xue@rmit.edu.au
Contact person for public queries
Name 43055 0
Dr Tony Zhang
Address 43055 0
RMIT University
PO Box 71
Bundoora, VIC 3083
Country 43055 0
Australia
Phone 43055 0
+61 3 9925 7788
Fax 43055 0
Email 43055 0
tony.zhang@rmit.edu.au
Contact person for scientific queries
Name 43056 0
Dr Tony Zhang
Address 43056 0
RMIT University
PO Box 71
Bundoora VIC, 3083
Country 43056 0
Australia
Phone 43056 0
+61 3 9925 7788
Fax 43056 0
Email 43056 0
tony.zhang@rmit.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOral granulated Chinese herbal medicine (YXBCM01) plus topical calcipotriol for psoriasis vulgaris: Study protocol for a double-blind, randomized placebo controlled trial.2014https://dx.doi.org/10.1186/1745-6215-15-495
EmbaseAdd-on effect of PSORI-CM01 to topical calcipotriol for moderate psoriasis vulgaris: A multi-center, randomized, double-blind pilot study.2021https://dx.doi.org/10.1002/ctm2.286
N.B. These documents automatically identified may not have been verified by the study sponsor.