Pilot, Non-pharmacological Clinical Investigation to Evaluate the Efficacy and Tolerability of a Dietary Supplement Containing EndoGen™ as an Adjunct Treatment to Current Therapy, in Endometriosis Symptoms in Fertile Women With Confirmed Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 13
- 主要终点
- Percentage of participants identified as a responder
研究概览
简要总结
Current treatments for endometriosis, such as NSAIDs and hormone therapies, are meant for long-term use but often cause side effects, including stomach, liver, heart, and kidney issues; allergies; and hormonal problems like weight gain, acne, and bone loss. Therefore, one option being studied is a food supplement based on parsley extract (Petroselinum crispum), rosemary extract (Rosmarinus Officinalis L.), and selenium, combined with mountain celery and Vitamins B6, D, and E. The study's goal is to show improvement in pain and reduced use of NSAIDs in fertile women with endometriosis.
详细描述
This is a small, early-stage study designed to test whether a four-month treatment with EndOK Green-a supplement made from EndoGen (TM), a mixture based on parsley extract (Petroselinum crispum), rosemary extract (Rosmarinus Officinalis L.), and selenium-can help reduce pain and lower the need for NSAIDs in women with moderate endometriosis (classified as stage 2 to 4 by the American Fertility Society). EndOK Green extract contains natural compounds like flavonoids (apigenin and luteolin), myristicin, and apiol, which may help ease symptoms through anti-inflammatory, antioxidant, and hormone-balancing effects, with fewer side effects than standard medications. This study includes a 4-week observational run-in period designed to exclude patients who show a clinically meaningful response without receiving any additional treatment.
Following this period, the investigational product will be administered for 16 consecutive weeks. Treatment responders will be defined as patients who meet either of the following criteria during the last 4 weeks of the treatment phase, specifically during the menstrual period:
A reduction of at least 20% from baseline on the VAS100 pain scale (e.g., if baseline pain is 8, a score of 6.4 is sufficient), and/or a 50% reduction from baseline in exposure (duration or dosage) of NSAIDs or other pain relievers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •for the Initial Run-In Phase
- •Written informed consent, signed and dated personally by the patient.
- •Female between the ages of 18 and 45 (including limits), with no race limitation.
- •Documented endometriosis, confirmed by laparoscopy, ultrasound, or MRI, with or without biopsy, performed up to 36 months prior to the start of this investigation and independently of it.
- •Stable health condition and stable drug treatments within the past 2 months.
- •Endometriosis with a grade 2 (mild) to grade 4 (severe) AFSr score, whether or not treated with sex hormones, contraceptives, or any other specific treatment, stable for a minimum of 2 months. Note: In a first phase of the investigation, patients in class 2 and 3 will be recruited, while in a second phase, patients in class 4 will also be recruited.
- •10-point Visual Analogue Scale (VAS) score of pain due to endometriosis of at least 4 for at least 2 days in the 4 weeks prior to run-in.
- •Inclusion criteria for treatment initiation Patients will start treatment with EndOK Green if they meet all of the following criteria.
- •Negative urine pregnancy test.
- •Difference, for at least two days, of no more than 10 in the 10-point Visual Analogue Scale (VAS) (10%) between the 4 weeks prior to the screening visit and the end of the run-in phase, provided that at least one menstruation occurred in the period.
- •No change in background therapy.
排除标准
- •Patients will be excluded if they meet even one of the following criteria:
- •Pregnancy, breastfeeding, or intending to become pregnant during the time this investigation will be conducted.
- •Absence of cycles for at least 3 months.
- •Previous hysterectomy or oophorectomy.
- •Pelvic inflammatory disease regardless of its etiology (Chlamydia Trachomatis, Neisseria gonorrhoeae, fungi, etc.) or presence of ovarian cysts.
- •Known hypersensitivity or allergy to the active substances and/or any component of the product under investigation.
- •Patient who has taken, within 4 weeks prior to inclusion, or is currently taking, dietary supplements for the treatment of pelvic pain or other symptoms of endometriosis.
- •Participation in any clinical study that has been ongoing or concluded for less than three months.
- •Patient with one or more psychiatric disorders, such as alcoholism, substance abuse or addictive disorder, bipolar disorder, schizophrenia, or other personality disorders.
- •Patient who, in the opinion of the gynecologist, will not be able to meet the prerequisites required for this investigation.
结局指标
主要结局
Percentage of participants identified as a responder
时间窗: Baseline, week 8 and week 16
Assessed using the 10-point Visual Analogue Scale (VAS) or use of NSAIDs or pain relievers. A "Treatment responder" will be defined as a reduction from baseline of at least 20% change in the 10-point Visual Analogue Scale (VAS) in the last 04 weeks during the menstrual phase or a 50% reduction from baseline in exposure (duration or dosage) to NAIDs or pain relievers.
次要结局
- Change from baseline in Pain Intensity using Endometriosis Health Profile (EHP)-30 Questionnaire(Baseline,week 8, week 16)
- Measurement of Adherence to treatment(Baseline,Week 4, week 8, week 12, week 16)
- Changes in NSAID or other pain medication use(Baseline, Week 4, Week 8, Week 12, Week 16)
- Overall self-assessment of efficacy and tolerability using a 5-point scale(Week 16)
- Overall physician-assessment of efficacy and tolerability using a 5-point scale(Week 16)
- Change from baseline in Pain Intensity using Endometriosis Health Profile (EHP)-30 Questionnaire(Baseline,week 8, week 16)
- Change from baseline in quality of life evaluated using the Endometriosis Health Profile (EHP)-30 core questionnaire(Baseline,week 8, week 16)
- Change from baseline in quality of life measured by the Endometriosis Health Profile (EHP)-30 modular questionnaire(Baseline,Week 8 and Week 16)
- Incidence of treatment-emergent effects (Safety and Tolerability)(Baseline, week 4, week 8, week 12 and week 16)
- Measurement of Adherence to treatment(Baseline,Week 4, week 8, week 12, week 16)
- Changes in NSAID or other pain medication use(Baseline, Week 4, Week 8, Week 12, Week 16)
- Overall self-assessment of efficacy and tolerability using a 5-point scale(Week 16)
- Overall physician-assessment of efficacy and tolerability using a 5-point scale(Week 16)