Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000358246
Ethics application status
Approved
Date submitted
11/03/2009
Date registered
26/05/2009
Date last updated
5/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The safety and efficacy of Zen Harmony in relieving the symptoms of menopause
Scientific title
A study of the safety and efficacy of Zen Harmony in relieving the symptoms of menopause
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The symptoms of menopause 4678 0
Condition category
Condition code
Alternative and Complementary Medicine 4988 4988 0 0
Herbal remedies
Alternative and Complementary Medicine 4989 4989 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chinese and western herbal medicine including
Rehmannia glutinosa root, 1.2g,
Angelica polymorpha root, 200mg,
Dioscorea opposita root rhiz, 200mg,
Paeonia lactiflora root, 200mg,
Bupleurum falcatum root, 200mg,
Vitex agnus-castus fruit, 100mg,
Calcium hydrogen phosphate, 350mg,
Calcium amino acid chelate, 50mg,
Magnesium amino acid chelate, 50mg,
Cholecalciferol (Vitamin D3 100IU), 2.5mcg, taken orally twice a day for 12 weeks of treatment. Every particpant will take a placebo for 4 weeks and then the active treatment for 12 weeks, twice daily.Placebo comprised of the same excipent base as the active treatment. The particpants will take two tablets twice daily with warm water 15 minutes before food for 4 weeks. The tablets will be taken orally. Past researchers have found a noticeable placebo effect on menopausal symptoms. The literature indicates that the most effective method to avoid this anomaly is to utilise a methodology similar to that which this trial proposes
Intervention code [1] 4441 0
Treatment: Other
Comparator / control treatment
No control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238018 0
Vasomotor symptoms (flushing)
Timepoint [1] 238018 0
Vasomotor symptoms (flushing) participants will record the number of vasomotor symptoms daily in a purpose designed daily diary. These will be checked and recorded at each of the timepoint clinics listed below.
Secondary outcome [1] 241838 0
Improvement in scores in the Menopause Rating Scale
Timepoint [1] 241838 0
Baseline week 4, week 8 and week 12. The participants will complete the questionnaires at clinics held at timepoints
Secondary outcome [2] 241839 0
Improvement in scores in the Women's Health questionnaire
Timepoint [2] 241839 0
Baseline week 4, week 8 and week 12. The participants will complete the questionnaires at clinics held at timepoints
Secondary outcome [3] 241841 0
Improvemement in the scores of the Greene climateric scale
Timepoint [3] 241841 0
Baseline week 4, week 8 and week 12. The participants will complete the questionnaires at clinics held at timepoints

Eligibility
Key inclusion criteria
Females aged between 45 and 65 years
A recorded minimum of 21 hot flushes per week during placebo run in.
Amenorrhea between 2 and 6 consecutive months duration in the year prior to entry
In good general health
Adequate venous access
Minimum age
45 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Follicle stimulating hormone levels less than 30mIU/ml
Individuals who have had a hysterectomy
Individuals who are vegetarian
Individual consumes soy products more then once a week
Individuals taking antibiotics or antacids
Individuals taking hormone preparations three months prior to enrolment
Individuals with disorders of the gastro intestinal tract
Individuals with atrial fibrillation
Individuals with bleeding disorders
Individuals taking anticoagulant medication
Individuals who consume more than 1 cup of coffee per day
Individuals with cholecystitis and/or gallstones
Individuals taking diuretic medications
Individuals who consume more than 1 alcoholic drink per day
Individuals with a known allergy to the herbal medications
Individuals with serum urea, electrolytes and creatinine greater than 2 times the upper limit of normal at baseline
Liver function tests greater than 3 times the upper limit of normal at baseline
Individuals unwilling to cease current herbal, vitamin and mineral supplements
Participants who have participated in another clinical trial in the last 30 days
Participants unwilling to comply with the study protocol
Any other condition, which in the opinion of the investigators could compromise the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
none
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4860 0
Commercial sector/Industry
Name [1] 4860 0
Martin & Pleasance
Country [1] 4860 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Martin & Pleasance
Address
7 Rocklea Drive Port Melbourne Victoria 3207
Country
Australia
Secondary sponsor category [1] 4398 0
None
Name [1] 4398 0
Address [1] 4398 0
Country [1] 4398 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6921 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 6921 0
Southern Cross University
Military Road
Lismore NSW 2480
Ethics committee country [1] 6921 0
Australia
Date submitted for ethics approval [1] 6921 0
12/02/2009
Approval date [1] 6921 0
06/03/2009
Ethics approval number [1] 6921 0
ECN-09-014

Summary
Brief summary
This is a descriptive study of a group of 15 women to comment on the possibility of an association between changes in menopausal symptoms following the use of a complementary therapy. Participants will have good general health and demonstrate a recorded minimum of 21 hot flushes per week and above 80% compliance during placebo run in. They will self administer 2 placebo tablets twice daily over the 28 day run in period and two tablets of Zen Harmony twice daily over 12 weeks of active treatment. Participants will be supplied with a daily diary containing a record of vasomotor symptoms (flushing) and instructed how to complete the required data. They will also complete the Greene Climacteric Scale, the Women's Health questionnaire and the Menopause rating scale at each clinic visit. .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29377 0
Address 29377 0
Country 29377 0
Phone 29377 0
Fax 29377 0
Email 29377 0
Contact person for public queries
Name 12624 0
Dr Joan O'Connor
Address 12624 0
NatMed-Research
Southern Cross University
Military Road
Lismore NSW
2480
Country 12624 0
Australia
Phone 12624 0
+61 2 66 20 3649
Fax 12624 0
Email 12624 0
[email protected]
Contact person for scientific queries
Name 3552 0
Professor Stephen Myers
Address 3552 0
NatMed-Research
Southern Cross University
Military Road
Lismore NSW
2480
Country 3552 0
Australia
Phone 3552 0
+61 2 66 20 3403
Fax 3552 0
Email 3552 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.