ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12624000731594

Ethics application status

Approved

Date submitted

31/05/2024

Date registered

14/06/2024

Date last updated

11/07/2024

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

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1308-7517

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Menstrual distress

Menstrual pain

Condition category

Condition code

Reproductive Health and Childbirth

Menstruation and menopause

Alternative and Complementary Medicine

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]

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]

Menstrual distress

Timepoint [1]

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]

Menstrual pain

Timepoint [2]

Secondary outcome [1]

Psychological symptoms associated with menstruation

Timepoint [1]

Secondary outcome [2]

Physical symptoms associated with menstruation

Timepoint [2]

Secondary outcome [3]

Quality of life

Timepoint [3]

(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]

General Pain

Timepoint [4]

(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]

Intake of pain-relieving medications

Timepoint [5]

Secondary outcome [6]

High-sensitivity C-reactive protein

Timepoint [6]

Baseline: day after completion of menses/ bleeding (before intervention commences)
Endpoint: day after completion of following menses/ bleeding (completion of intervention)

Secondary outcome [7]

Physical function

Timepoint [7]

(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]

Physical role functioning

Timepoint [8]

(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]

Emotional wellbeing

Timepoint [9]

(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]

Social functioning

Timepoint [10]

(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]

General health

Timepoint [11]

(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]

Hot flushes

Timepoint [12]

(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]

Hot flushes

Timepoint [13]

(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]

Hot flushes

Timepoint [14]

(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]

Liver function profile (safety measure)

Timepoint [15]

Baseline: day after completion of menses/ bleeding (before intervention commences)
Endpoint: day after completion of following menses/ bleeding (completion of intervention)

Secondary outcome [16]

Renal function profile (safety measure)

Timepoint [16]

Baseline: day after completion of menses/ bleeding (before intervention commences)
Endpoint: day after completion of following menses/ bleeding (completion of intervention)

Secondary outcome [17]

Complete blood count profile (safety measure)

Timepoint [17]

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?

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

26/07/2024

Actual

Date of last participant enrolment

Anticipated

28/10/2024

Actual

Date of last data collection

Anticipated

6/12/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Bioactive Natural Health Pty Ltd

Address [1]

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Bioactive Natural Health Pty Ltd

Address

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Clinical Research Australia

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Institute of Integrative Medicine Human Research Ethics Committee

Ethics committee address [1]

https://niim.com.au/research/niim-human-research-ethics-committee

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/05/2024

Approval date [1]

13/06/2024

Ethics approval number [1]

0142E_2024

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

Dr Adrian Lopresti

Address

Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023

Country

Australia

Phone

+61 08 94487376

Fax

[email protected]

Contact person for public queries

Name

Adrian Lopresti

Address

Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023

Country

Australia

Phone

+61 08 94487376

Fax

[email protected]

Contact person for scientific queries

Name

Adrian Lopresti

Address

Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023

Country

Australia

Phone

+61 08 94487376

Fax

[email protected]

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 ([email protected])

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.

Trial Review

Documents added manually

Documents added automatically