Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000247471
Ethics application status
Approved
Date submitted
26/03/2025
Date registered
4/04/2025
Date last updated
16/06/2025
Date data sharing statement initially provided
4/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
An examination into the safety and efficacy of Khapregesic®, a Khaya senegalensis preparation, on vasomotor, physical, and psychological wellbeing in women experiencing perimenopause and menopause
Scientific title
An examination into the safety and efficacy of Khapregesic®, a Khaya senegalensis preparation, on vasomotor, physical, and psychological wellbeing in women experiencing perimenopause and menopause: a randomised, double-blind, placebo-controlled trial.
Secondary ID [1] 314044 0
None
Universal Trial Number (UTN)
U1111-1320-8593
Trial acronym
Linked study record
This is a separate study

Health condition
Health condition(s) or problem(s) studied:
Menopausal symptoms 336788 0
Condition category
Condition code
Reproductive Health and Childbirth 333279 333279 0 0
Menstruation and menopause
Alternative and Complementary Medicine 333280 333280 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Khaya Senegalensis Dry Stem Bark (Khapregesic) (2 tablets taken orally, two times daily, with or without food, delivering 2000 mg a day for 28 days). Adherence to tablet intake will be measured by a daily record of tablet intake using a daily questionnaire and a tablet count by the participants at the end of the study.
Intervention code [1] 330625 0
Treatment: Other
Comparator / control treatment
A matching placebo (microcrystalline cellulose) tablet in terms of taste and appearance and containing all ingredients/excipients except the active ingredient (Khaya Senegalensis).
Control group
Placebo

Outcomes
Primary outcome [1] 340853 0
Menopausal symptoms
Timepoint [1] 340853 0
Days 0 (pre-commencement of intervention), 14, and 28 (primary endpoint) post-intervention commencement
Secondary outcome [1] 445270 0
Hot flushes
Timepoint [1] 445270 0
Days 0 (pre-commencement of intervention), 14, and 28 post-intervention commencement
Secondary outcome [2] 445267 0
Vasomotor symptoms
Timepoint [2] 445267 0
Days 0 (pre-commencement of intervention), 14, and 28 post-intervention commencement
Secondary outcome [3] 445266 0
Physical symptoms
Timepoint [3] 445266 0
Days 0 (pre-commencement of intervention), 14, and 28 post-intervention commencement
Secondary outcome [4] 445269 0
Hot flushes
Timepoint [4] 445269 0
Days 0 (pre-commencement of intervention), 14, and 28 post-intervention commencement
Secondary outcome [5] 445265 0
Psychological symptoms
Timepoint [5] 445265 0
Days 0 (pre-commencement of intervention), 14, and 28 post-intervention commencement
Secondary outcome [6] 445274 0
Global Improvment
Timepoint [6] 445274 0
Days 14, and 28 post-interevention commencement
Secondary outcome [7] 448775 0
Gastrointestinal symptoms
Timepoint [7] 448775 0
Days 0 (pre-commencement of intervention), 14, and 28 post-intervention commencement
Secondary outcome [8] 445276 0
Renal function profile (safety measure)
Timepoint [8] 445276 0
Days 0 (pre-commencement of intervention) and 28 post-intervention commencement
Secondary outcome [9] 445271 0
Sleep quality
Timepoint [9] 445271 0
Days 0 (pre-commencement of intervention), 14, and 28 post-intervention commencement
Secondary outcome [10] 445268 0
Hot flushes
Timepoint [10] 445268 0
Days 0 (pre-commencement of intervention), 14, and 28 post-intervention commencement
Secondary outcome [11] 445275 0
Liver function profile (safety measure)
Timepoint [11] 445275 0
Days 0 (pre-commencement of intervention) and 28 post-intervention commencement
Secondary outcome [12] 445272 0
Sleep quality
Timepoint [12] 445272 0
Days 0 (pre-commencement of intervention), 14, and 28 post-intervention commencement
Secondary outcome [13] 445273 0
Fatigue
Timepoint [13] 445273 0
Days 0 (pre-commencement of intervention), 14, and 28 post-intervention commencement
Secondary outcome [14] 448776 0
Stool form
Timepoint [14] 448776 0
Days 0 (pre-commencement of intervention), 14, and 28 post-intervention commencement
Secondary outcome [15] 445277 0
Complete blood count profile (safety measure)
Timepoint [15] 445277 0
Days 0 (pre-commencement of intervention) and 28 post-intervention commencement

Eligibility
Key inclusion criteria
1. Women aged 42 to 62 years
2. Women with an intact uterus and ovaries
3. Presence of menopausal/ climactic symptoms for at least 3 months
4. A score greater than or equal to 12 on the Greene Climacteric Scale
5. Has not experienced menses in the last 12 months; or for at least 3 months has experienced changes in the menstrual cycle (e.g., bleeding days, heaviness of bleeding, or days between menses)
6. Non-smoker
7. BMI between 18 and 30 kg/m2
8. No plan to commence new treatments over the study period.
9. Understand, willing and able to comply with all study procedures.
10. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Minimum age
42 Years
Maximum age
62 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hypertension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, biliary disease, autoimmune disease, cancer/malignancy, endocrine disease, or chronic/acute pain condition.
2. Diagnosis of a neurological or psychiatric condition including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), Parkinson’s disease, Alzheimer’s disease, intracranial haemorrhage, or head injury.
3. In the last 3 months, commenced, or changed pharmaceutical medications likely to affect treatment outcomes or an expectation to change during the study duration
4. In the last 3 months, commenced, or changed nutritional or herbal supplements likely to affect treatment outcomes or an expectation to change during the study duration
5. Planned major lifestyle change in the next 2 months.
6. Alcohol intake greater than 14 standard drinks per week
7. Current or 12-month history of regular illicit drug use
8. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant during the study period.
9. In the last year has had a significant surgery that affects general health or daily function, or a planned surgery in the next 2 months
10. Participation in any other clinical trial in the last month

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)
Opaque numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
5/06/2025
Date of last participant enrolment
Anticipated
3/10/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
140
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 318551 0
Commercial sector/Industry
Name [1] 318551 0
Bioactive Natural Health Pty Ltd
Country [1] 318551 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bioactive Natural Health Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320948 0
Commercial sector/Industry
Name [1] 320948 0
Clinical Research Australia
Address [1] 320948 0
Country [1] 320948 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317151 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 317151 0
Ethics committee country [1] 317151 0
Australia
Date submitted for ethics approval [1] 317151 0
04/03/2025
Approval date [1] 317151 0
15/04/2025
Ethics approval number [1] 317151 0
0154E_2025

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

Contacts
Principal investigator
Name 140170 0
Dr Adrian Lopresti
Address 140170 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 140170 0
Australia
Phone 140170 0
+61 08 94487376
Fax 140170 0
Email 140170 0
[email protected]
Contact person for public queries
Name 140171 0
Adrian Lopresti
Address 140171 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 140171 0
Australia
Phone 140171 0
+61 08 94487376
Fax 140171 0
Email 140171 0
[email protected]
Contact person for scientific queries
Name 140172 0
Adrian Lopresti
Address 140172 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 140172 0
Australia
Phone 140172 0
+61 08 94487376
Fax 140172 0
Email 140172 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of the study sponsor

Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Access is subject to approvals by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


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.