Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000015246
Ethics application status
Approved
Date submitted
19/11/2008
Date registered
8/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised control trial on the effect of a herbal product, 30Plus, on mood swings and anxiety in younger women
Scientific title
In women aged 18-45 years with mild to moderate depression and anxiety, are 2 tablets daily of 30Plus more effective than placebo in reducing depression and anxiety symptoms
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild to moderate depression and anxiety 4000 0
Condition category
Condition code
Alternative and Complementary Medicine 4199 4199 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two tablets daily of 30Plus to be taken orally over 8 weeks.
30Plus
Each tablet of 30Plus contains the following active ingredients:
Tyrosine 150mg
Cimicifuga racemosa extract, (Equivalent to dry rhizome 60mg)
Pyridoxine HCl 25mg
Folic acid 100mcg
Cyanocobalamin 150mcg
Chromium picolinate 200mcg
(Equivalent to Chromium 25mcg)
Calcium hydrogen phosphate 25mg
(Equivalent to Calcium 6mg)

B group vitamins are commonly taken by women who suffer from premenstrual syndrome (PMS) and systematic reviews have shown that vitamin B6, in particular, is an effective treatment for both the physical and psychological symptoms. Black cohosh extracts have been used traditionally to treat PMS and menopause symptoms. A recent large randomised controlled trial has shown that black cohosh extract is an effective treatment for menopause symptoms, including psychological symptoms. Chromium supplements have been variably shown to improve glucose metabolism and might help reduce sugar cravings. Tyrosine appears to prevent the substantial decline in various aspects of cognitive performance and mood associated with many kinds of acute stress.
Intervention code [1] 3725 0
Treatment: Drugs
Comparator / control treatment
Two tablets daily of Placebo to be taken orally. The placebo is made to look and taste exactly like the active treatment and is made of filler which contains Dextrose and a low dose of calcium (6mg).
Control group
Placebo

Outcomes
Primary outcome [1] 5096 0
Change from baseline in Depression and Anxiety Stress Scale (42-DASS)
Timepoint [1] 5096 0
8 weeks
Secondary outcome [1] 8564 0
Change from baseline in premenstrual physical symptoms. This will be assessed using the Physical Symptom Score derived from a four item questionnaire designed to assess pre-menstrual physical symptoms.
Timepoint [1] 8564 0
8 weeks
Secondary outcome [2] 8565 0
Change from baseline in 42-DASS sub-scores
Timepoint [2] 8565 0
8 weeks

Eligibility
Key inclusion criteria
Have noticed at least one of the following psychological symptoms over the 3-6 months prior to screening:
- Depression
- Angry outbursts
- Irritability
- Anxiety
- Confusion
- Social withdrawal
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Severe depression, or any current use of substances known to affect mood.

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)
Participants who complete an informed consent process and fulfill all inclusion and exclusion criteria will be enrolled in the study and randomised. All randomised subjects will be given two identical appearing and tasting tablets per day. Allocation concealment will be achieved via numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be determined on a 1:1 basis using a random number table that is created in Excel by “Rand-between functions” tools.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4190 0
Commercial sector/Industry
Name [1] 4190 0
Natural Health Products Pty Ltd
Country [1] 4190 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Natural Health Products Pty Ltd
Address
19 Taree Street
Burleigh Heads
Qld 4220
Country
Australia
Secondary sponsor category [1] 3764 0
None
Name [1] 3764 0
Address [1] 3764 0
Country [1] 3764 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6247 0
South Eastern Sydney and Illawarra Area Health Service Human Research Ethics Committee - Northern Hospital Network
Ethics committee address [1] 6247 0
RoomG71, Edmund Blackett Building
Cnr High & Avoca Streets
Randwick NSW 2031
Ethics committee country [1] 6247 0
Australia
Date submitted for ethics approval [1] 6247 0
Approval date [1] 6247 0
10/09/2008
Ethics approval number [1] 6247 0
08/041

Summary
Brief summary
The study will evaluate how effective a herbal formulation is in decreasing psychological symptoms such as anxiety and depression. The study will run for 12 weeks in total, and over that time participants will be asked to complete one questionnaire every 4 weeks to evaluate their symptoms of depression and anxiety.

Half the women in the study will take 2 tablets daily of the study product while the other half will take 2 placebo tablets. A placebo is a dummy treatment, which looks and tastes like the real medication, but contains no active ingredient.
Trial website
www.rhw.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29148 0
Address 29148 0
Country 29148 0
Phone 29148 0
Fax 29148 0
Email 29148 0
Contact person for public queries
Name 12305 0
Jinzhu Liu
Address 12305 0
Barbara Gross Research Unit
Level 0, Royal Hospital for Women
Barker St
Randwick NSW 2031
Country 12305 0
Australia
Phone 12305 0
+61 2 9382 6621
Fax 12305 0
+61 2 9382 6660
Email 12305 0
[email protected]
Contact person for scientific queries
Name 3233 0
Jinzhu Liu
Address 3233 0
Barbara Gross Research Unit
Level 0, Royal Hospital for Women
Barker St
Randwick, NSW 2031
Country 3233 0
Australia
Phone 3233 0
+61 2 9382 6621
Fax 3233 0
+61 2 9382 6660
Email 3233 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.