None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 140 women aged 42 to 62 years experiencing menopausal symptoms will be randomly assigned to receive 2 grams daily of a proprietary preparation of pure Khaya Senegalensis Dry Stem Bark (Khapregesic) or a placebo for 28 days. Changes in menopausal symptoms, sleep, and fatigue will be assessed before, during, and after the intake of the investigational product. It is hypothesised that compared to the placebo, Khaya Senegalensis will be associated with greater improvements in menopausal symptoms, sleep and fatigue.
Interventions
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.
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
42 Years to 62 Years
Healthy volunteers
No
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.
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
Outcome results
None listed