None listed
Conditions
Brief summary
Endometriosis is a prevalent chronic disease affecting up to 14% of presumed females at birth between 18 to 45 years old in Australia. Characterised by endometrial-like tissue proliferating outside the uterine cavity, it leads to chronic pelvic pain, dysmenorrhea, dyspareunia, infertility, reduced quality of life, and significant economic burden to both individuals and the healthcare system. Current treatment options, including hormonal therapies and surgery, are often ineffective, poorly tolerated, or unsuitable for long-term use, underscoring the urgent need for novel interventions. The MMEND trial evaluates the efficacy of a vascular-active, anti-inflammatory nutraceutical and a semi-essential amino acid both of which possess potent anti-inflammatory and anti-angiogenic properties, in reducing endometriosis-related pain and improving quality of life. This randomised, 48-week, two-arm, double-blind phase II clinical trial will recruit 150 participants aged 18 to 45 with a confirmed medical diagnosis of endometriosis. The primary outcome is a reduction in endometriosis-associated pain and improvement in quality of life. Secondary outcomes include the modulation of blood biomarkers of inflammation and angiogenesis.
Interventions
A phase-II, randomised, double-blind, two-arm, 48-week study (plus 8-week screening) will be conducted in individuals with medically confirmed endometriosis. This study aims to evaluate the effects of garlic extract alone or in combination with L-arginine on endometriosis associated pain, quality of life and inflammatory and angiogenic biomarkers. Each participant will be randomised into the 2 arms and self-administer the allocated nutraceuticals.
Arm 1: Garlic Extracts (oral capsule)
Arm 2: G
A phase-II, randomised, double-blind, two-arm, 48-week study (plus 8-week screening) will be conducted in individuals with medically confirmed endometriosis. This study aims to evaluate the effects of garlic extract alone or in combination with L-arginine on endometriosis associated pain, quality of life and inflammatory and angiogenic biomarkers. Each participant will be randomised into the 2 arms and self-administer the allocated nutraceuticals. Arm 1: Garlic Extracts (oral capsule) Arm 2: Garlic Extracts + L-arginine or Placebo (oral capsule) The intervention will be provided as follows: - Phase 1: Weeks 0–16: All receive 200 mg Garlic Extract daily. - Phase 2: Weeks 17–32: Continue Garlic Extract + randomised to either 1500 mg L-arginine or placebo daily. - Follow up: Weeks 33–48: 16-week follow-up period. No intervention, follow-up assessments continue. Capsule counts will be conducted at study visits to ensure adequate adherence to intervention protocol.
A phase-II, randomised, double-blind, two-arm, 48-week study (plus 8-week screening) will be conducted in individuals with medically confirmed endometriosis. This study aims to evaluate the effects of a vascular-active, anti-inflammatory nutraceutical alone or in combination with a semi-essential amino acid on endometriosis associated pain, quality of life and inflammatory and angiogenic biomarkers. Each participant will be randomised into the 2 arms and self-administer the allocated nutraceutic
A phase-II, randomised, double-blind, two-arm, 48-week study (plus 8-week screening) will be conducted in individuals with medically confirmed endometriosis. This study aims to evaluate the effects of a vascular-active, anti-inflammatory nutraceutical alone or in combination with a semi-essential amino acid on endometriosis associated pain, quality of life and inflammatory and angiogenic biomarkers. Each participant will be randomised into the 2 arms and self-administer the allocated nutraceuticals. Arm 1: Vascular-active, anti-inflammatory nutraceutical (oral capsule) Arm 2: Vascular-active, anti-inflammatory nutraceutical + semi-essential amino acid or Placebo (oral capsule) The intervention will be provided as follows: - Phase 1: Weeks 0–16: All receive a vascular-active, anti-inflammatory nutraceutical. - Phase 2: Weeks 17–32: Continue a vascular-active, anti-inflammatory nutraceutical + randomised to either a semi-essential amino acid or placebo daily. - Follow up: Weeks 33–48: 16-week follow-up period. No intervention, follow-up assessments continue. Capsule counts will be conducted at study visits to ensure adequate adherence to intervention protocol.
Sponsors
Curtin University
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 45 Years
Healthy volunteers
No
Inclusion criteria
1. Participant provided written, informed consent. 2. Medically confirmed diagnosis of endometriosis via laparoscopy (with or without histological confirmation), magnetic resonance imaging (MRI) or ultrasound imaging 3. Moderate to severe endometriosis-associated pain, scoring 4 or greater on visual analogue scale (VAS). 4. During the baseline period a mean pain score of 4 or greater for at least one VAS pain domain. 5. Pelvic pain that has occurred for longer than 6 months. 6. Premenopausal female, aged 18-45 years old (inclusive) at screening. 7. Able to commit to taking oral capsules once a day for 32 weeks. 8. Able to complete electronic weekly pain questionnaire over 56 weeks. 9. Have access to the internet to complete electronic questionnaires. 10. If sexually active, participant can commit to using appropriate contraception (condoms, IUD, continued oral contraception). 11. Be willing to and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Exclusion criteria
1. Pregnancy (or planning to be pregnant within the study period) or breastfeeding. 2. Surgery related to endometriosis within 6 months of screening period. 3. Any surgery planned during study period (56 weeks). 4. Chronic pelvic pain that, in the opinion of the investigator, was not caused by endometriosis and required chronic analgesic use or other chronic therapy, or that interfered with the assessment of endometriosis-related pain. 5. The participant had any known condition, which in the opinion of the investigator constituted a risk or contraindication to participating in the study, or that could interfere with the study objectives, implementation or evaluation. 6. Clinical reports of kidney/liver dysfunction. 7. Unknown genital bleeding. 8. L-arginine tablets or garlic extract tablets in previous 3 months prior to screening. 9. Adverse reactions to food containing L-arginine or garlic. 10. Known risks of bleeding or coagulopathy or currently on blood-thinning medications. 11. Use of anticoagulants or any other medication (including supplements) that causes blood thinning. 12. Current diagnosis of cancer (with exception to cancers of the skin), haemochromatosis or diabetes. 13. History of diabetes, hypertension, hypotension, collagen vascular disease, vasculitis or renal disease/failure. 14. Acute/chronic pain disorders, infections, cardiovascular or cerebrovascular disease. 15. Evidence of significant unmanaged mood or anxiety-related symptoms, at the discretion of the investigator. 16. History of substance abuse/dependence/addiction. 17. Smoke >1 pack of cigarettes a day. 18. Changes (started, stopped or changed dosage) to hormonal contraception within 3 months of screening. 19. Changes (started, stopped or changed the dosage) on any pharmaceutical medication or herbal/natural medicine targeting endometriosis symptoms in the previous 3 months of screening. 20. Participation in concurrent research trial.
Outcome results
None listed