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Trial registered on ANZCTR


Registration number
ACTRN12621000499886
Ethics application status
Approved
Date submitted
27/01/2021
Date registered
29/04/2021
Date last updated
28/02/2023
Date data sharing statement initially provided
29/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase II Randomised Double-Blind, placebo-controlled clinical trial evaluating the efficacy of Happy Hormones in menopausal women.
Scientific title
A Phase II Randomised Double-Blind, placebo-controlled clinical trial evaluating the efficacy of Happy Hormones for menopausal-related symptoms in menopausal women.
Secondary ID [1] 303275 0
none
Universal Trial Number (UTN)
Trial acronym
wHHiM trial
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Menopause 320469 0
Condition category
Condition code
Alternative and Complementary Medicine 318353 318353 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is Happy hormones:

Dose: 4 capsules daily (equivalent to 5grams) - 2 capsules with breakfast, and 2 capsules with dinner

Duration: 12 weeks.


The herbal formulation of Happy Hormones consists of whey protein, liquorice root powder, maca, psyllium husks, natural vanilla flavour, red clover powder, passion flora powder, sage powder, guar gum, natural berry flavour, wild yam powder, raspberry leaf powder, gymnema sylvestre extract, dandelion root extract, black cohosh extract, chaste berry extract and stevia extract.
Each 5g of powder contains:
Salvia officinalis (Garden Sage) ext equiv to dry leaf 3g.
Vitex agnus-castus (Chaste Berry) ext equiv to dry fruit 2g
Actaea racemose (Black Cohosh) ext equkiv to dry rhizome 280mg standardized to triterpene glycosides 1mg.
Passiflora incarnata (Passion Flower), et equiv to dry herb flowering and fruiting 416mg,
Trifolium pratense (Red Clover) ext equiv to dry leaf 337.2mg
Lepidium meyenii (Maca) tuber powder 333mg
Dioscorea oppositifolia (Chinese yam) ext equiv to dry root and rhizome 266.5mg
Rubus idaues (Raspberry) ext equiv to dry root 150mg
Taraxacum officinale (Dandelion) ext equiv to dry leaf 150mg
Gymnema sylvesytre (Gymnema) ext equiv to dry leaf 111mg
Glycyrrhiza Glabra (Liquorice) powder equiv to dry root and stolon 14.85mg

Free from artificial sweeteners, flavours, colours and preservatives. Contains lactose and sugars. This powder will be put into maroon capsules whereby 4 capsules will equal 1 teaspoon of powder per day.

The compliance strategy is via capsule return. At each follow up, the capsules remaining will be countered and checked with the participant diary. As this trial is via telehealth, the participants will be send the participant diary into the centre. Each follow up will be via zoom or teams and the participant must show the RA the container and count the number left during the follow up appointment.
Intervention code [1] 319577 0
Treatment: Other
Comparator / control treatment
The placebo consists of 100% organic brown rice and will be presented in a maroon capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 326322 0
To evaluate the efficacy of Happy Hormones compared to placebo in healthy menopausal women by the change in scores in menopause-related health symptoms as measured by the Menopausal Rating Scale (MRS) scores from baseline to 12 weeks.
Timepoint [1] 326322 0
Week 0, 4, 8, 12 weeks (primary endpoint)
Secondary outcome [1] 391060 0
To evaluate the quality of life of healthy menopausal women taking Happy Hormones compared to placebo in healthy menopausal women by the menopausal rating scale from baseline to 12 weeks.
Timepoint [1] 391060 0
Week 0. week 4, week 8 and 12 weeks
Secondary outcome [2] 391061 0
To assess the safety of Happy Hormones from baseline to 12 weeks via adverse events and side effects using the CTCAE v5 and a self reported participant diary.
Timepoint [2] 391061 0
0 week, 4 weeks, 8 weeks and 12 weeks
Secondary outcome [3] 391062 0
To evaluate the number of vasomotor episodes daily from baseline to 12 weeks via a self reported participant diary where they write the number of vasomotor episodes each morning (this accounts for the following day and night)
Timepoint [3] 391062 0
0 week, 4 weeks, 8 weeks and 12 weeks

Eligibility
Key inclusion criteria
Females between 40 to 66 years of age
More than 3 vasomotor symptoms (hot flushes) within a 24-hour period.
BMI between 18-35 kg/m2
Normal liver and kidney function (within range of the pathology lab used)
Ability to speak and understand English sufficiently to comprehend the purpose and risks of the study and to provide consent
Minimum age
40 Years
Maximum age
66 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Undiagnosed vaginal bleeding.
Use of HRT in the previous three months before baseline
Use of any herbal formula that affects hormonal levels in the previous three months before baseline
History of alcohol or drug abuse and currently still drinks more than 2 standard glasses of alcohol daily or uses recreational drugs
History of or current breast, endometrial or ovarian cancer.
Ovariectomy or complete hysterectomy
Uncontrolled and or untreated hypertension (defined as systolic blood pressure >160mm Hg and/ or diastolic blood pressure >100 mm Hg.)
Uncontrolled psychiatric disorders.
Uncontrolled and/or diagnosed medical conditions that may interfere with study medication e.g. Diabetes mellitus, hepatic or renal dysfunction.

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)
All researchers will be blinded to the randomization and the allocation. A computer-generated randomized group allocation (A or B) will be provided by the computer system, Redcap once the participant has been enrolled. The number is concealed until the research assistant enrolls the participant into the data management system. The number will then appear on the participants file. The participants will be allocated to one of two groups and the group allocation will be noted on the computer system data management and the participant hard copy chart.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be a computer-generated random number based on block randomisation with varying block length ranging from 4 to 8. The numbers will be generated via https://www.randomizer.org/.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data will be analysed via SPSS 26.0. Analyses will be conducted on an intention-to-treat basis with per-protocol. Descriptive statistics will summarise data as either means (absolute, relative or percentage change) with standard deviations or medians with interquartile range as appropriate for the data. The primary outcome Kupperman Index score after 12 weeks will be compared between groups using univariate analysis (ANCOVA) or equivalent non-parametric test depending on the distribution of data, and the effects reported as group differences with 95% confidence intervals. Secondary outcomes will be analysed using comparable methods depending on the data type.
The subject population for analysis will be classified as: Protocol-compliant population. This means all participants randomised into the study that received the protocol required study product (administered at least 90% each week) exposure for at least one month.
4.1 END OF TRIAL ANALYSIS PLAN:
1. Scores of MRS: Total score of the MRS will be calculated, and compared between the intervention and placebo after 12 weeks via ANCOVA. If there were a number of dropouts or lost to follow up, missing data will be multiplied imputed.

2. Each arm scores of MRS: Total scores from baseline to week 12 will be analysed for the intervention and the placebo via paired t-tests.

3. Number of vasomotor events: Total number of events from each arm will be compared between the intervention and placebo via chi square test.

4. Each arms number of vasomotor events: Total numbers from baseline to week 12 will be analysed for the intervention and the placebo via paired t-tests.

5. Scores of SF-36: Total score of the SF-36 will be conducted comparing the intervention and placebo over 12 weeks will be via ANCOVA. If there were a number of dropouts or lost to follow up, a GEE longitudinal analyses will be conducted.

6. Each arm scores of the SF-36: Total scores from baseline to week 12 will be analysed for the intervention and the placebo via paired t-tests. If there were a number of dropouts or lost to follow up, missing data will be brought forward.

7. Safety: Number of side effects for both arms will be presented descriptively

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/05/2021
Actual
19/05/2021
Date of last participant enrolment
Anticipated
2/05/2022
Actual
31/07/2021
Date of last data collection
Anticipated
26/09/2022
Actual
30/09/2022
Sample size
Target
148
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 32840 0
2000 - Sydney
Recruitment postcode(s) [2] 32841 0
3000 - Melbourne
Recruitment postcode(s) [3] 32842 0
4000 - Brisbane
Recruitment postcode(s) [4] 32843 0
6000 - Perth
Recruitment postcode(s) [5] 32844 0
5000 - Adelaide
Recruitment postcode(s) [6] 32845 0
2600 - Canberra
Recruitment postcode(s) [7] 32846 0
7000 - Hobart
Recruitment postcode(s) [8] 32847 0
7250 - Launceston
Recruitment postcode(s) [9] 32848 0
4870 - Cairns
Recruitment postcode(s) [10] 32849 0
0800 - Darwin

Funding & Sponsors
Funding source category [1] 307685 0
Government body
Name [1] 307685 0
Australian Federal Government, Department of Industry, Science, Energy and Resources. Innovations Connections Grant
Country [1] 307685 0
Australia
Funding source category [2] 307687 0
Commercial sector/Industry
Name [2] 307687 0
Food Supplements International Pty Ltd t/a Happy Healthy You
Country [2] 307687 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
1 Military Road,
East Lismore NSW 2480
Country
Australia
Secondary sponsor category [1] 308385 0
None
Name [1] 308385 0
none
Address [1] 308385 0
none
Country [1] 308385 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307721 0
Southern Cross University HREC
Ethics committee address [1] 307721 0
Ethics committee country [1] 307721 0
Australia
Date submitted for ethics approval [1] 307721 0
15/03/2021
Approval date [1] 307721 0
20/04/2021
Ethics approval number [1] 307721 0
2021/036

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108270 0
Dr Janet Schloss
Address 108270 0
National Centre for Naturopathic Medicine
Southern Cross University
1 Military Road,
East Lismore NSW 2480
Country 108270 0
Australia
Phone 108270 0
+61 436101306
Fax 108270 0
Email 108270 0
[email protected]
Contact person for public queries
Name 108271 0
Janet Schloss
Address 108271 0
National Centre for Naturopathic Medicine
Southern Cross University
1 Military Road,
East Lismore NSW 2480
Country 108271 0
Australia
Phone 108271 0
+61 436101306
Fax 108271 0
Email 108271 0
[email protected]
Contact person for scientific queries
Name 108272 0
Janet Schloss
Address 108272 0
National Centre for Naturopathic Medicine
Southern Cross University
Military Road,
East Lismore NSW 2480
Country 108272 0
Australia
Phone 108272 0
+61 436101306
Fax 108272 0
Email 108272 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual data will be made available. All data will be non-identifiable and data presented will be in groups.


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.