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Trial registered on ANZCTR


Registration number
ACTRN12616000299404
Ethics application status
Approved
Date submitted
6/02/2016
Date registered
7/03/2016
Date last updated
7/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Facial Candling on Inflammatory Mediators and Pain in Allergic Rhinitis Patients:A randomized controlled trial
Scientific title
The Effect of Facial Candling on Inflammatory Mediators and Pain in Allergic Rhinitis Patients:A randomized controlled trial
Secondary ID [1] 288489 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic rhinitis 297544 0
Condition category
Condition code
Inflammatory and Immune System 297747 297747 0 0
Allergies
Alternative and Complementary Medicine 297862 297862 0 0
Other alternative and complementary medicine
Physical Medicine / Rehabilitation 297863 297863 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients Allergic rhinitis in group (Group A) will be treated by one certified practitioner of traditional facial candling, with the treatment being applied within 15 minutes in one session. The practitioner will pass the smoke release from facial candle around the patients face. The white like powder appears on the patients face will be clean with water.
Intervention code [1] 293848 0
Treatment: Other
Comparator / control treatment
The patients with allergic rhinitis in the control group (Group B) will receive no treatment.
Control group
Active

Outcomes
Primary outcome [1] 297275 0
The level of substance P in nasal mucus and blood samples
Timepoint [1] 297275 0
The nasal mucus and blood samples will be taken 5 minutes before the treatment (pre-treatment), and immediately after treatment (post-treatment).
Secondary outcome [1] 320569 0
The level of inflammatory mediators [i.e. TNF-alpha, IL-4, IL-5, IL-6,IL-10 and IL-13, in both blood and nasal mucus samples.
Timepoint [1] 320569 0
The nasal mucus and blood samples will be taken 5 minutes before the treatment (pre- treatment) and immediately after the treatment (post-treatment).

Eligibility
Key inclusion criteria
1.Age between 18- 65 years old
2.Participant had a positive skin prick test to at least one of :
-seafood; or
-house dust mite; or
-animal dander; or
-pollen
3.Pass urine pregnancy test for female.
4.Willing to participate in this study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Pregnant woman
2.Asthma and Chronic obstructive pulmonary disease (COPD) patients
3.Patients who taking pain killer pills, received antihistamine drug and steroid

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)
Allergic rhinitis patients attending the health science Clinic, Universiti Teknologi MARA (UiTM), Malaysia, who fulfill the inclusion criteria will be screened and will be invited to participate into this study. For those who has one or more than one of the exclusion criteria will be excluded in this study.

Explanatory statement will be given to those eligible participants and written informed consent will be obtained before the commencement of the study. Consenting participants will then be randomly allocated using a simple random sampling method into the 2 groups:

(i) facial candling treatment (Group A) or
(ii) control groups (Group B
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using sealed envelopes which is pick-up one of the two sealed envelopes. These envelopes containing group division.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis:
The sample size is calculated using Power and Sample Size (PS) software 3.1.2 version. Since there is no previous finding of the effect of facial candling treatment on substance P, we chose the related result who have done study on substance P which is traditional Thai massage on lower back pain patients reported by Mackawan et al. The difference between the mean values of the intervention and control groups, and the standard deviation (post-massage) of substance P levels were used as parameters for sample size calculation. Previous study by Mackawan et. al had reported that the mean levels of substance P in the intervention group and control group are 50.43 pg/mL and 56.27 pg/mL, respectively (the difference in the mean values between the experimental and control groups is 5.84 pg/mL). Their findings also showed that the response within each subject group was normally distributed, with the highest recorded standard deviation being 8.3. The Type I error probability associated with this test of the null hypothesis is 0.05. A sample of 33 experimental subjects and 33 control subjects is therefore required to reject the null hypothesis that the population means of the experimental and control groups are equal, with a probability (power) of 0.8.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2016
Actual
Date of last participant enrolment
Anticipated
30/06/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 7577 0
Malaysia
State/province [1] 7577 0
Selangor

Funding & Sponsors
Funding source category [1] 292838 0
University
Name [1] 292838 0
Research Acculturation Grant Scheme (RAGS), Universiti Teknologi MARA (UiTM
Country [1] 292838 0
Malaysia
Primary sponsor type
Individual
Name
Dr. Long Chiau Ming
Address
Faculty of Pharmacy,
Level 11, FF1,
Universiti Teknologi MARA (UiTM), Campus Puncak Alam,
42300 Puncak Alam, Selangor,
Malaysia.
Country
Malaysia
Secondary sponsor category [1] 291582 0
None
Name [1] 291582 0
Address [1] 291582 0
Country [1] 291582 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294343 0
Research Ethics Committe UiTM
Ethics committee address [1] 294343 0
Research Management Institute (RMI),
3rd Floor Bangunan Wawasan,
Jalan Sarjana 1/2,
Universiti Teknologi MARA (UiTM),
40450 Shah Alam,
Selangor, Malaysia
Ethics committee country [1] 294343 0
Malaysia
Date submitted for ethics approval [1] 294343 0
12/09/2015
Approval date [1] 294343 0
21/01/2016
Ethics approval number [1] 294343 0
600-RMI (5/1/6)

Summary
Brief summary
Treatment of facial candling has been very popular especially in Malaysia. It is believed that traditional treatment helps in relieving allergic rhinitis. There is, however, a lack of scientific evidence to support the practice of traditional treatment and the mechanism as to how facial candling treatment reduce allergic rhinitis. The aim of this study is to investigate the immediate effect of facial candling, substance P, inflammatory mediators among allergic rhinitis patients.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 754 754 0 0
/AnzctrAttachments/370071-Appendix-A-method-protocol-clinical.docx
Attachments [2] 757 757 0 0
/AnzctrAttachments/370071(v06-02-2016-00-52-44)-Appendix-B-assesment-clinical.docx
Attachments [3] 758 758 0 0
/AnzctrAttachments/370071-Appendix-C-Safety-Monitoring-Plan.docx
Attachments [4] 759 759 0 0
/AnzctrAttachments/370071-Ethical approval.pdf

Contacts
Principal investigator
Name 63342 0
Dr Long Chiau Ming
Address 63342 0
Faculty of Pharmacy
Level 11, FF 1 ,
Universiti Teknologi MARA (UiTM), Campus Puncak Alam,
42300 Puncak Alam,
Selangor, Malaysia.
Country 63342 0
Malaysia
Phone 63342 0
+6012-4778468
Fax 63342 0
Email 63342 0
[email protected]
Contact person for public queries
Name 63343 0
Nor Faizatul Fatikah Binti Ismail
Address 63343 0
Brain research labroratory, level 7,
Universiti Teknologi MARA (UiTM), Campus Puncak Alam,
42300 Puncak Alam, Selangor, Malaysia
Country 63343 0
Malaysia
Phone 63343 0
+6016-8751792
Fax 63343 0
Email 63343 0
[email protected]
Contact person for scientific queries
Name 63344 0
Long Chiau Ming
Address 63344 0
Faculty of Pharmacy
Level 11, FF 1 ,
Universiti Teknologi MARA (UiTM), Campus Puncak Alam,
42300 Puncak Alam,
Selangor, Malaysia.
Country 63344 0
Malaysia
Phone 63344 0
+6012-4778468
Fax 63344 0
Email 63344 0
[email protected]

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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
EmbaseThe immediate effect of facial candling on inflammatory mediators, substance P, symptoms severity, and quality of life in allergic rhinitis patients: Study protocol for a randomized controlled trial.2017https://dx.doi.org/10.1097/MD.0000000000007511
N.B. These documents automatically identified may not have been verified by the study sponsor.