Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000149864
Ethics application status
Approved
Date submitted
31/01/2012
Date registered
2/02/2012
Date last updated
2/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An open label clinical trial of an orally-dosed herbal formulation Zinova (Registered Trademark) for the prevention of dysmenorrhoea (menstrual pain).
Scientific title
An open label clinical trial of an orally-dosed herbal formulation Zinova (Registered Trademark) for the prevention of dysmenorrhoea (menstrual pain) in females with a normal menstrual cycle (28-32 days).
Secondary ID [1] 279823 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysmenorrhoea 285712 0
Condition category
Condition code
Alternative and Complementary Medicine 285894 285894 0 0
Herbal remedies
Reproductive Health and Childbirth 285901 285901 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The investigational product is Zinova (Registered Trademark), a provisionally patented two piece capsule-form medication containing three chemically defined herbal extracts Terminalia chebula (300 mg), Curcumin BetaSorb (Registered Trademark) (100mg) and Zingiber officinale (80mg). The participants take 4 capsules/day (2 in the morning and 2 in the evening) for 3 months, commencing on day 1 of follicular phase of the menstrual cycle.
Intervention code [1] 284141 0
Treatment: Other
Intervention code [2] 284156 0
Prevention
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286391 0
Assess the effectiveness of the treatment in reducing menstrual pain during the menstrual cycle, assessed using visual analogue scale (VAS).
Timepoint [1] 286391 0
Baseline Menstruation (Daily during menstruating using a patient diary)
Month 1, 2 and 3 (Daily during menstruation using a patient diary)
Secondary outcome [1] 295757 0
Assess the effectiveness of the treatment in reducing analgesic use during the menstrual cycle using a patient diary detailing medication type/dosage/time.
Timepoint [1] 295757 0
Baseline Menstruation (Daily during menstruating using a patient diary)
Month 1, 2 and 3 (Daily during menstruation using a patient diary)

Eligibility
Key inclusion criteria
Female
Aged 18 to 45
Normal Menstrual Cycle 28-32 days for at least 6 months
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Irregular menstrual cycles
Peri-menopausal
Menopausal
Chronic health problems- diabetes, heart disease, renal/liver disease
Reproductive health problems - eg PCOS, endometriosis,
Depression
Pregnant
Lactating
Attempting pregnancy

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. Patients complete an on-Line screening questionnaire
2. Patients are booked in to clinic
3. Patients attend clinic for a pre-trial interview
4. Patients are enrolled into the study
5. Patients provided numbered bottles in order of enrolment
6. No concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
n/a
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284601 0
Commercial sector/Industry
Name [1] 284601 0
Trilogie Products Pty. Ltd.
Country [1] 284601 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Applied Science and Nutrition Pty. Ltd.
Address
P.O. Box 68
New Farm 4005
Brisbane QLD
Country
Australia
Secondary sponsor category [1] 283522 0
None
Name [1] 283522 0
Address [1] 283522 0
Country [1] 283522 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286596 0
Australian College of Natural Medicine
Ethics committee address [1] 286596 0
362 Water Street
Fortitude Valley 4006
Brisbane, QLD.
Ethics committee country [1] 286596 0
Australia
Date submitted for ethics approval [1] 286596 0
08/07/2008
Approval date [1] 286596 0
02/03/2009
Ethics approval number [1] 286596 0
HREC-020

Summary
Brief summary
This is a single-site, open-label short-term clinical trial with baseline data collection.

Approximately 20 female participants aged between 18 and 45 years will be recruited from the CRO’s participant database and public media. Following initial screening via telephone, potential participants will attend the clinic for an information session and will be requested to provide their consent for inclusion in the trial. Consenting potential participants will undergo a medical assessment including lifestyle, current medications, physical examination, medical history, and menstrual history; this data will be used for the comprehensive screening and to provide contextual data for the study.


The primary outcome measure is the pain VAS rating scales. The secondary outcome measure is analgesic use.

The expected duration of the trial is five consecutive menses (approximately five months) for each participant. Baseline data will be collected during the first 2 menstrual cycles prior to intervention and for 3 months while on treatment.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 33699 0
Address 33699 0
Country 33699 0
Phone 33699 0
Fax 33699 0
Email 33699 0
Contact person for public queries
Name 16946 0
Amanda Rao
Address 16946 0
188 James Street
New Farm 4005
Brisbane, QLD
Country 16946 0
Australia
Phone 16946 0
+ 61 414 488559
Fax 16946 0
n/a
Email 16946 0
[email protected]
Contact person for scientific queries
Name 7874 0
Amanda Rao
Address 7874 0
188 James Street
New Farm 4005
Brisbane, QLD
Country 7874 0
Australia
Phone 7874 0
+ 61 414 488559
Fax 7874 0
Email 7874 0
[email protected]

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.