Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000209897
Ethics application status
Approved
Date submitted
16/02/2012
Date registered
20/02/2012
Date last updated
20/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of Chinese herbal medicine (RCM-102) for treatment of seasonal allergic rhinitis (hayfever)
Scientific title
Pharmacological actions and clinical evaluation of a Chinese Herbal formula in the treatment of seasonal allergic rhinitis: A double blind, randomized, placebo-controlled trial.
Secondary ID [1] 279951 0
Application (2003/70) was filed with the Clinical Trials Branch under its Clinical Trial Notification (CTN) Scheme, Therapeutic Goods Administration (TGA), Department for Health and Ageing, Canberra, Australia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
seasonal allergic rhinitis 285865 0
Condition category
Condition code
Inflammatory and Immune System 286051 286051 0 0
Allergies
Respiratory 286071 286071 0 0
Other respiratory disorders / diseases
Alternative and Complementary Medicine 286079 286079 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Astragalus membranaceus (Fisch.) Bge
Bupleurum chinense D.C
Glycyrrhiza uralensis (Fisch.)
Magnolia liliflora (Desr.)
Mentha haplocalyx Briq.
Schizonepeta Tenuifolia Briq.
Saposhnikovia divaricata (Turcz.)
Scutellaria baicalensis Georgi.


two capsules each time, three times daily (with four hours interval) for a period of eight weeks durong the pollen season (semtember-December). Each capsule contained 500 mg of a mixture of granules of either herbal medicine (Koda Internationals Pty Ltd, Lane Cove, N.S W. Australia) or placebo ingredient (rice starch from Sigma Pharmaceuticals Pty Ltd (Melbourne, Victoria, Australia).
Intervention code [1] 284279 0
Treatment: Other
Comparator / control treatment
Rice starch capsules
Control group
Placebo

Outcomes
Primary outcome [1] 286531 0
nasal symptoms (sneezing; rhinorrhea; itchy nose; obstruction) and non-nasal symptoms (palate, and/or throat; itchy, watery, red eye) on a 5-point scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe, using a symptoms severity five-point scale, VAS,
Timepoint [1] 286531 0
Day 1, 14, 28, 42,56,70
Secondary outcome [1] 296093 0
General Quality of Life (SF36)
Timepoint [1] 296093 0
Day 1, 14, 28, 42,56,70
Secondary outcome [2] 296168 0
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Timepoint [2] 296168 0
Day 14, 28, 42,56,70
Secondary outcome [3] 296169 0
Liver and kidney function test
Timepoint [3] 296169 0
Day 1 and Day 70

Eligibility
Key inclusion criteria
(a) age between 18 to 65 years with two or more symptoms for at least two years with a total nasal symptom score (TNSS) of at least six;
(b) a positive pollen skin prick test (SPT).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) initiated immunotherapy since last SAR season;
(b) HIV positive;
(c) other active respiratory disease within 30 days of study; (d) receiving oral corticosteroid treatment;
(e) pregnancy or lactation;
(f) nasal polyposis; and
(g) unable to read or understand English.

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)
Randomisation will be achieved using clinical computer software package STUDY MANAGER which also generates the treatment code and a patient code. This computer program will be protected from unauthorised entry by a password.
Blinding will be achieved by using pre-packing of placebo and real NSARF capsules with identical appearance and smell. The codes and labelling will be recorded by a password protected computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284721 0
University
Name [1] 284721 0
RMIT University
Country [1] 284721 0
Australia
Primary sponsor type
Individual
Name
Professor Charlie Xua
Address
RMIT University
Bundoora West campus
PO Box70
Bundoora VIC 3083
Country
Australia
Secondary sponsor category [1] 283634 0
None
Name [1] 283634 0
Address [1] 283634 0
Country [1] 283634 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286725 0
RMIT HREC
Ethics committee address [1] 286725 0
RMIT University
Bundoora West campus
PO Box70
Bundoora VIC 3083
Ethics committee country [1] 286725 0
Australia
Date submitted for ethics approval [1] 286725 0
02/10/2002
Approval date [1] 286725 0
30/10/2002
Ethics approval number [1] 286725 0
HREC18/02

Summary
Brief summary
Subjects were required to take two capsules each time, three times daily (with four hours interval) for a period of eight weeks. Each capsule contained 500 mg of a mixture of granules of either herbal medicine (Koda Internationals Pty Ltd, Lane Cove, N.S W. Australia) or placebo ingredient (rice starch from Sigma Pharmaceuticals Pty Ltd (Melbourne, Victoria, Australia). The capsules were prepared by a TGA approved Good Manufacturing Practice (GMP) certified manufacturer (GMP Pharmaceuticals Pty Ltd Girraween, N.S.W. Australia). The two types of capsules were identical in weight and appearance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33783 0
Address 33783 0
Country 33783 0
Phone 33783 0
Fax 33783 0
Email 33783 0
Contact person for public queries
Name 17030 0
George Lenon
Address 17030 0
RMIT University
Bundoora west campus
Plenty Rd
Bundoora
Victoria 3083

POBox 70
Bundoora 3083
Country 17030 0
Australia
Phone 17030 0
+61399256587
Fax 17030 0
+61399257178
Email 17030 0
george.lenon@rmit.edu.au
Contact person for scientific queries
Name 7958 0
Dr George Lenon
Address 7958 0
RMIT University
Bundoora west campus
Plenty Rd
Bundoora
Victoria 3083

POBox 70
Bundoora 3083
Country 7958 0
Australia
Phone 7958 0
+61399256587
Fax 7958 0
+61399257178
Email 7958 0
george.lenon@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
Dimensions AILack of efficacy of a herbal preparation (RCM-102) for seasonal allergic rhinitis: a double blind, randomised, placebo-controlled trial2012https://doi.org/10.5415/apallergy.2012.2.3.187
N.B. These documents automatically identified may not have been verified by the study sponsor.