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

Not Applicable

• Conditions: Menstrual distress; Menstrual pain; Reproductive Health and Childbirth - Menstruation and menopause; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12624000731594
• Lead Sponsor: Bioactive Natural Health Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-14
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 90

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.; 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; 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

• Study Type: Interventional
• Study Design: Not specified