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Trial registered on ANZCTR


Registration number
ACTRN12624000731594p
Ethics application status
Submitted, not yet approved
Date submitted
31/05/2024
Date registered
14/06/2024
Date last updated
14/06/2024
Date data sharing statement initially provided
14/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
An examination into the safety and efficacy of Khaya senegalensis on pain, physical and emotional wellbeing in women experiencing menstrual distress: a randomised, double-blind, placebo-controlled trial
Scientific title
An examination into the safety and efficacy of Khaya senegalensis on pain, physical and emotional wellbeing in women experiencing menstrual distress: a randomised, double-blind, placebo-controlled trial
Secondary ID [1] 312265 0
None
Universal Trial Number (UTN)
U1111-1308-7517
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menstrual distress 333982 0
Menstrual pain 333983 0
Condition category
Condition code
Reproductive Health and Childbirth 330646 330646 0 0
Menstruation and menopause
Alternative and Complementary Medicine 330647 330647 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Khaya Senegalensis Dry Stem Bark (Khapregesic) (2 tablets taken orally, three times daily, with or without food, delivering 3000 mg a day from the start of menses/bleeding to the start of the following menses/bleeding. Adherence to tablet intake will be measured by a daily record of tablet intake using a phone application and a tablet count by the participants at the end of the study.
Intervention code [1] 328723 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] 338398 0
Menstrual distress
Timepoint [1] 338398 0
1. Baseline - before commencement of intervention: Daily records starting 7 days before menses and continuing until the end of menses/ bleeding
2. Post-intervention commencement: daily records until the end of the following menses/bleeding
Primary outcome [2] 338399 0
Menstrual pain
Timepoint [2] 338399 0
1. Baseline - before commencement of intervention: Daily records starting 7 days before menses and continuing until the end of menses/ bleeding
2. Post-intervention commencement: daily records until the end of the following menses/bleeding
Secondary outcome [1] 435762 0
Psychological symptoms associated with menstruation
Timepoint [1] 435762 0
1. Baseline - before commencement of intervention: Daily records starting 7 days before menses and continuing until the end of menses/ bleeding
2. Post-intervention commencement: daily records until the end of the following menses/bleeding
Secondary outcome [2] 435763 0
Physical symptoms associated with menstruation
Timepoint [2] 435763 0
1. Baseline - before commencement of intervention: Daily records starting 7 days before menses and continuing until the end of menses/ bleeding
2. Post-intervention commencement: daily records until the end of the following menses/bleeding
Secondary outcome [3] 435764 0
Quality of life
Timepoint [3] 435764 0
(1) Baseline (day of completion of 1st menses/bleeding); (2) week 2 (2 weeks after treatment commencement), and (3) immediately after completion of 2nd menses/bleeding
Secondary outcome [4] 435765 0
General Pain
Timepoint [4] 435765 0
(1) Baseline (day of completion of 1st menses/bleeding); (2) week 2 (2 weeks after treatment commencement), and (3) immediately after completion of 2nd menses/bleeding
Secondary outcome [5] 435766 0
Intake of pain-relieving medications
Timepoint [5] 435766 0
1. Baseline - before commencement of intervention: Daily records starting 7 days before menses and continuing until the end of menses/ bleeding
2. Post-intervention commencement: daily records until the end of the following menses/bleeding
Secondary outcome [6] 435767 0
High-sensitivity C-reactive protein
Timepoint [6] 435767 0
Baseline: day after completion of menses/ bleeding (before intervention commences)
Endpoint: day after completion of following menses/ bleeding (completion of intervention)
Secondary outcome [7] 435768 0
Physical function
Timepoint [7] 435768 0
(1) Baseline (day of completion of 1st menses/bleeding); (2) week 2 (2 weeks after treatment commencement), and (3) immediately after completion of 2nd menses/bleeding
Secondary outcome [8] 435769 0
Physical role functioning
Timepoint [8] 435769 0
(1) Baseline (day of completion of 1st menses/bleeding); (2) week 2 (2 weeks after treatment commencement), and (3) immediately after completion of 2nd menses/bleeding
Secondary outcome [9] 435770 0
Emotional wellbeing
Timepoint [9] 435770 0
(1) Baseline (day of completion of 1st menses/bleeding); (2) week 2 (2 weeks after treatment commencement), and (3) immediately after completion of 2nd menses/bleeding
Secondary outcome [10] 435771 0
Social functioning
Timepoint [10] 435771 0
(1) Baseline (day of completion of 1st menses/bleeding); (2) week 2 (2 weeks after treatment commencement), and (3) immediately after completion of 2nd menses/bleeding
Secondary outcome [11] 435772 0
General health
Timepoint [11] 435772 0
(1) Baseline (day of completion of 1st menses/bleeding); (2) week 2 (2 weeks after treatment commencement), and (3) immediately after completion of 2nd menses/bleeding
Secondary outcome [12] 435773 0
Hot flushes
Timepoint [12] 435773 0
(1) Baseline (day of completion of 1st menses/bleeding); (2) week 2 (2 weeks after treatment commencement), and (3) immediately after completion of 2nd menses/bleeding
Secondary outcome [13] 435774 0
Hot flushes
Timepoint [13] 435774 0
(1) Baseline (day of completion of 1st menses/bleeding); (2) week 2 (2 weeks after treatment commencement), and (3) immediately after completion of 2nd menses/bleeding
Secondary outcome [14] 435775 0
Hot flushes
Timepoint [14] 435775 0
(1) Baseline (day of completion of 1st menses/bleeding); (2) week 2 (2 weeks after treatment commencement), and (3) immediately after completion of 2nd menses/bleeding
Secondary outcome [15] 435776 0
Liver function profile (safety measure)
Timepoint [15] 435776 0
Baseline: day after completion of menses/ bleeding (before intervention commences)
Endpoint: day after completion of following menses/ bleeding (completion of intervention)
Secondary outcome [16] 435777 0
Renal function profile (safety measure)
Timepoint [16] 435777 0
Baseline: day after completion of menses/ bleeding (before intervention commences)
Endpoint: day after completion of following menses/ bleeding (completion of intervention)
Secondary outcome [17] 435778 0
Complete blood count profile (safety measure)
Timepoint [17] 435778 0
Baseline: day after completion of menses/ bleeding (before intervention commences)
Endpoint: day after completion of following menses/ bleeding (completion of intervention)

Eligibility
Key inclusion criteria
1. Menstruating females aged 18 to 50 years
2. Experience mild to moderately severe pain before and/or during menstruation, with a history of at least 3 months.
3. Experience physical and/or emotional symptoms associated with menstruation with a history of at least 3 months
4. Have a regular menstrual cycle length of 21 to 35 days
5. Non-smoker
6. BMI between 18 and 30 kg/m2
7. No plan to commence new treatments over the study period.
8. Understand, willing and able to comply with all study procedures.
9. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Minimum age
18 Years
Maximum age
50 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, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, cancer/malignancy, endocrine disease, or chronic/acute pain condition.
2. Diagnosis of a neurological or psychiatric conditions 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 or brain injury.
3. Regular medication intake including but not limited to opioids, corticosterone, hormone-replacement therapy, gonadotrophin releasing hormone agonists.
4. Change in medication in the last 2 months or an expectation to change during the study duration.
5. Vitamins or herbal supplements that are reasonably expected to influence study measures.
6. In the last month, commenced or changed the dose of nutritional and/or herbal supplements that may impact on treatment outcomes.
7. Planned major lifestyle change in the next 2 months.
8. Alcohol intake greater than 14 standard drinks per week
9. Current or 12-month history of illicit drug abuse
10. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant during the study period.
11. In the last year or in the next 3 months, any significant surgeries (except exploratory surgery for endometriosis and other menstrual conditions undertaken/occurring before or after the study period)
12. 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
28/10/2024
Actual
Date of last data collection
Anticipated
6/12/2024
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316650 0
Commercial sector/Industry
Name [1] 316650 0
Bioactive Natural Health Pty Ltd
Country [1] 316650 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bioactive Natural Health Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 318836 0
Commercial sector/Industry
Name [1] 318836 0
Clinical Research Australia
Address [1] 318836 0
Country [1] 318836 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315429 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 315429 0
https://niim.com.au/research/niim-human-research-ethics-committee
Ethics committee country [1] 315429 0
Australia
Date submitted for ethics approval [1] 315429 0
03/05/2024
Approval date [1] 315429 0
Ethics approval number [1] 315429 0

Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 90 women aged 18 to 50 years experiencing psychological and physical symptoms associated with menstruation will be randomly assigned to receive a proprietary preparation of pure Khaya Senegalensis Dry Stem Bark Khapregesic (3 grams daily) or a placebo for one menstrual cycle. Pain, mood, and physical wellbeing changes will be assessed before, during, and after the intake of the investigational product. Moreover, changes in the intake of pain-relieving medication will be examined, along with changes in blood measures of C-reactive protein, liver function, renal function, and complete blood count.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134670 0
Dr Adrian Lopresti
Address 134670 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 134670 0
Australia
Phone 134670 0
+61 08 94487376
Fax 134670 0
Email 134670 0
adrian@clinicalresearch.com.au
Contact person for public queries
Name 134671 0
Adrian Lopresti
Address 134671 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 134671 0
Australia
Phone 134671 0
+61 08 94487376
Fax 134671 0
Email 134671 0
adrian@clinicalresearch.com.au
Contact person for scientific queries
Name 134672 0
Adrian Lopresti
Address 134672 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 134672 0
Australia
Phone 134672 0
+61 08 94487376
Fax 134672 0
Email 134672 0
adrian@clinicalresearch.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of the study sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator (adrian@clinicalresearch.com.au)


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.