None listed
Conditions
Brief summary
To examine the efficacy and cost-effectiveness of a modified traditional Chinese medicine formula (GynoclearTM) as a treatment for endometriosis related pain and fatigue. The project will utilise a placebo controlled, double blind, randomised controlled trial involving reproductive aged women surgically diagnosed with endometriosis. Baseline scores for pelvic pain, fatigue, painful intercourse (dysparunia) and rescue medication will be collected over four weeks. Women will be randomly allocated in a 1:1 ratio to active (GynoclearTM) or placebo capsules. Six capules will be taken daily for three months. The primary outcome is change in daily pelvic pain score at the end of the intervention. Safety and adverse event data will be collected during the trial and at a one month follow up period. If GynoclearTM shows evidence of efficacy and safety it will be another possible treatment option for the over 360,000 Australian women with endometriosis.
Interventions
Investigational Product/Therapy: Six (6) capsules of Gynoclear™ taken orally per day for 12 weeks. Dosing schedule will be three (3) capsules in the morning with food and three (3) capsules in the evening, with the evening meal if possible.
Gynoclear™ contains the following active ingredients: cinnamon (92 mg/cap), poria (92 mg/cap), safflower (92 mg/cap), tree peony (92 mg/cap), peony (92 mg/cap) and red sage (92 mg/cap).
Compliance to dosing regime will be monitored through study drug reconc
Investigational Product/Therapy: Six (6) capsules of Gynoclear™ taken orally per day for 12 weeks. Dosing schedule will be three (3) capsules in the morning with food and three (3) capsules in the evening, with the evening meal if possible. Gynoclear™ contains the following active ingredients: cinnamon (92 mg/cap), poria (92 mg/cap), safflower (92 mg/cap), tree peony (92 mg/cap), peony (92 mg/cap) and red sage (92 mg/cap). Compliance to dosing regime will be monitored through study drug reconciliation at Midpoint (Week 6) and at End of Treatment (Week 12).
Sponsors
Metagenics (Aust) Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
- Laparoscopic visualisation/confirmation of endometriosis in the last five years. - Have menstrual or non-menstrual pelvic pain rated greater than or equal to 2.5/10 on a numeric rating scale based off an average over one month via Endometriosis pain daily diary v3 scores. - Report at least ONE of the following: o Dysmenorrhea (period pain), o Dyspareunia (pain during or after sexual intercourse), o Dyschezia (pain before or during bowel motion) OR o Dysuria (pain prior to or during urination). - Willing to provide informed consent and adhere to the protocol. - Able to travel to a Laverty Pathology collection centre for two blood tests. - If sexually active, agreeing to use appropriate contraception to prevent pregnancy during the study period. - Has internet access (either via a mobile, tablet or computer) for completing the Endometriosis Pain Daily Diary v3 scores.
Exclusion criteria
- Have had endometriosis related surgery in the previous six months. - Started the oral or injectable contraceptive pill, GnRH-a or danazol within the last three months. - Started, stopped or changed dosage on any pharmaceutical medication or herbal/natural medicine targeting endometriosis symptoms (such as pregabalin, Nortriptyline, or other Chinese herbal medicine) in the previous three months. - Having a known allergy or intolerance to any of the ingredients in Gynoclear™. - Usage of anticoagulants (e.g. Warfarin, Heparin, Eliquis, Pradaxa, Xarelto) or any other medication, including supplements (e.g., Vitamin E, Gingko), that causes blood thinning. - History of coagulation disorders. - Currently pregnant or breast feeding or planning on becoming pregnant during the study period.
Outcome results
None listed