DO YOU HAVE PAIN AND OTHER SYMPTOMS ASSOCIATED WITH YOUR MENSTRUATION?
Volunteers are needed to examine the effects of an ingredient on menstrual-related symptoms in women aged 18 to 50 years.
This is a registered clinical trial with the Australian and New Zealand Clinical Trials Registry (Link to Registry Webpage)
Khaya senegalensis is a tree species native to Africa (and now also cultivated in Australia). Common names include African mahogany, dry zone mahogany, Gambia mahogany, khaya wood, and Senegal mahogany. Khaya senegalensis has traditionally been used to treat menstruation pain, dysmenorrhoea, ovulation disturbances, and digestive pain and discomfort. In this study, we are interested in investigating its effects on menstrual-related symptoms in women experiencing menstrual distress.
PLEASE NOTE: No travel to our office is required for this study, as all questionnaires are completed online. However, a blood sample will need to be collected at your nearest Australian Clinical Labs collection centre
There is no cost for participating in this study. To compensate you for your time and travel costs, you will be given a $200 Coles/Myer group gift voucher when you complete the study.
If you are between 18 and 50 years old, have a menstrual cycle between 21 and 35 days, and experience pain and other symptoms associated with your menstruation, we invite you to participate in this randomised, controlled study
Eligible participants will be RANDOMLY allocated into ONE of TWO treatment conditions:
- Daily intake of tablets containing Khaya senegalensis, or
- Daily intake of placebo (fake) tablets
This 12-week study consists of the following:
- Participate in a 10-minute phone interview to discuss the study and assess your eligibility to participate.
- Take the tablets for one menstrual cycle (2 tablets three times daily, containing either placebo or Khaya senegalensis).
- Complete online questionnaires comprising the following: (1) daily symptom ratings for 7 days starting before your period until the end of your period (these take 2 to 5 minutes), and (2) more comprehensive questionnaires every week, which take 5 minutes to complete.
- Have a blood sample collected at your nearest Australian Clinical Labs Collection centre at the beginning and end of the study
- Take the tablets for one menstrual cycle (2 tablets, three times daily, containing either placebo or Khaya senegalensis)
Please Note: All participants placed in the placebo group will be provided with a FREE 28-day supply of Khaya senegalensis tablets at the end of the study
You can download the full STUDY INFORMATION SHEET by clicking on the button at the bottom of this webpage.
Click on the image below to view the study design and requirements.
To be INCLUDED in the study, the following inclusion criteria must be met:
- You are a menstruating women aged 18 to 50 years
- You experience mild to moderately severe pain before and/or during menstruation, with a history of at least 3 months.
- You experience physical and/or emotional symptoms associated with menstruation with a history of at least 3 months
- You have a regular menstrual cycle length of 21 to 35 days
- You are a non-smoker
- You have a body mass index (BMI) between 18 and 30 kg/m2
- You have no plan to commence new treatments over the study period
- You understand and are willing and able to comply with all study procedures
- You are willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial
If any of the exclusion criteria below are met, you will not be suitable for participation in this study:
- You suffer 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.
- You are diagnosed with 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.
- You regularly take medications including but not limited to opioids, corticosterone, hormone-replacement therapy, and gonadotrophin-releasing hormone agonists.
- You have changed your medication in the last 2 months or expect to change it during the study duration.
- You are taking vitamins or herbal supplements reasonably expected to influence the study measures.
- In the last month, you commenced or changed the dose of nutritional and/or herbal supplements that may impact on treatment outcomes.
- You have planned a major lifestyle change in the next 2 months.
- Your alcohol intake is greater than 14 standard drinks per week
- You currently (or in the last 12 months) have used illicit drugs
- You are pregnant, breastfeeding, or intend to fall pregnant during the study period.
- In the last year or in the next 3 months, you have had significant surgeries (except exploratory surgery for endometriosis and other menstrual conditions undertaken/occurring before or after the study period)
- You have participated in another clinical trial in the last month
This study has been approved by the National Institute of Integrative Medicine (NIIM) Ethics Committee (Reference number: 0142E_2024)
If you are interested in participating in this study, click on the button below to complete the initial screening questionnaire. This questionnaire will take 10 minutes to complete and helps us assess your eligibility to participate in this study.
Please Note: All answers are confidential and will only be seen by study investigators. If you are not eligible to participate in this study, your records will be deleted immediately
Please Note: All answers are confidential and will only be seen by study investigators. If you are not eligible to participate in this study, your records will be deleted immediately
If you are interested in participating in this study, click on the button below to complete the initial screening questionnaire. This questionnaire will take 10 minutes to complete and helps us assess your eligibility for the study.
Please Note: All answers are confidential and will only be seen by study investigators. If you are not eligible to participate in this study, your records will be deleted immediately
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