Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000073202
Ethics application status
Approved
Date submitted
22/10/2008
Date registered
30/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acupuncture treatment for menstrual disorder in women with Polycystic Ovarian Syndrome (PCOS)
Scientific title
A randomised, single blinded, placebo controlled clinical trial of the effectiveness of Acupuncture in management of Polycystic Ovarian Syndrome – A multicentre trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovarian Syndrome 3862 0
Condition category
Condition code
Reproductive Health and Childbirth 4057 4057 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Body Acupuncture on selected body acupuncture points to be administered once a week for 12 weeks duration. Each acupuncture session lasts for 20 minutes. Principal acupuncture points used include R3, R4, EX-CA-18, SP6, ST 36.
Intervention code [1] 3676 0
Treatment: Devices
Comparator / control treatment
Sham Acupuncture - Acupuncture needle was not inserted at the treatment point. The needle will be placed at 0.5-1cm lateral to the real acupuncture point or use sham acupuncture needle holder. In either case, the acupuncture needle will not penetrate the skill. It will be administered once a week for 12 weeks duration. Each acupuncture session lasts for 20 minutes. Patients will not know whether they are receiving real or sham acupuncture throughout the study. However, women received sham acupuncture will be offered to received real acupuncture after the cessation of the study period.
Control group
Placebo

Outcomes
Primary outcome [1] 4954 0
Return of Menstruation at the conclusion of the treatment period. It will be assessed by participating women's information while filling in the questionnaires. Patients will be followed up once a month for 3 months after treatment.
Timepoint [1] 4954 0
Once a month for 3 months throughout the duration of treatment. Each acupuncture session lasts for 20 minutes. Participating individuals will be followed up once a month for up to 3 months after the treatment is completed.
Secondary outcome [1] 8362 0
Improved Luteinizing Hormone : Follicle Stimulating Hormone Ratio
Reduce Androgenic hormone concentration. This will be evaluated by a series of blood tests throughout the study
Timepoint [1] 8362 0
Once at the beginning of the treatment and also once after the conclusion of treatment.

Eligibility
Key inclusion criteria
Rottendam Consensus on PCOS: Any patient with the presence of 2 out of 3 criteria as listed below will be considered as having Polycystic Ovarian Syndrome:
1, Oligo/anovulation; 2, hyperandrogenaemia; 3, polycystic ovaries
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with one or more of the following conditions will be excluded:
1, Other active ovarian, uterine or pelvic inflammatory diseases; 2, Major systemic diseases; 3, Pregnancy

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)
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
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
99
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 1291 0
China
State/province [1] 1291 0
GuangZhou

Funding & Sponsors
Funding source category [1] 4036 0
Self funded/Unfunded
Name [1] 4036 0
Country [1] 4036 0
Primary sponsor type
Hospital
Name
Chinese Medicine Clinical Research Centre, Liverpool Hospital
Address
Chinese Medicine Clinical Research Centre, Liverpool Hospital, Elizabeth Street,
Liverpool, NSW 2170
Country
Australia
Secondary sponsor category [1] 3629 0
Hospital
Name [1] 3629 0
GuangDong Women and Children's Hospital, 13 Guang Yuan Xi Road, GuangZhou, GuangDong 510010
Address [1] 3629 0
13 Guang Yuan Xi Road, GuangZhou, GuangDong 510010
Country [1] 3629 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6121 0
University of New South Wales Human Ethics Committee
Ethics committee address [1] 6121 0
High Street, Kensington, NSW 2052
Ethics committee country [1] 6121 0
Australia
Date submitted for ethics approval [1] 6121 0
Approval date [1] 6121 0
Ethics approval number [1] 6121 0
07289

Summary
Brief summary
This study is aimed to evaluate the role of acupuncture treatment for menstrual disorder in women with polycystic ovarian syndrome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29063 0
Address 29063 0
Country 29063 0
Phone 29063 0
Fax 29063 0
Email 29063 0
Contact person for public queries
Name 12220 0
Dr Danforn Lim
Address 12220 0
Department of Obstetrics & Gynaecology,
Liverpool Hospital,
Elizabeth Street, Liverpool, NSW 2170
Country 12220 0
Australia
Phone 12220 0
+61 2 98285630
Fax 12220 0
Email 12220 0
celim@unswalumni.com
Contact person for scientific queries
Name 3148 0
Danforn Lim
Address 3148 0
Department of Obstetrics & Gynaecology,
Liverpool Hospital,
Elizabeth Street, Liverpool, NSW 2170
Country 3148 0
Australia
Phone 3148 0
+61 2 98285630
Fax 3148 0
Email 3148 0
celim@unswalumni.com

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
No additional documents have been identified.