None listed
Conditions
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.
Interventions
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.
Sponsors
Bioactive Natural Health Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
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.
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
Outcome results
None listed