Pilot Study on a Dietary Supplement With EndoGen™ as Adjunct Therapy in Women With Endometriosis

Endok s.r.l.

Status: Completed

Conditions: Endometriosis

Treatments: Dietary Supplement: MetrioFen Gocce

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07228975

EndOK 2023-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 36 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for the Initial Run-In Phase

1. Written informed consent, signed and dated personally by the patient.
2. Female between the ages of 18 and 45 (including limits), with no race limitation.
3. 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.
4. Stable health condition and stable drug treatments within the past 2 months.
5. 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.
6. 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.

1. Negative urine pregnancy test.
2. 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.
3. No change in background therapy.

Exclusion Criteria Patients will be excluded if they meet even one of the following criteria:

1. Pregnancy, breastfeeding, or intending to become pregnant during the time this investigation will be conducted.
2. Absence of cycles for at least 3 months.
3. Previous hysterectomy or oophorectomy.
4. Pelvic inflammatory disease regardless of its etiology (Chlamydia Trachomatis, Neisseria gonorrhoeae, fungi, etc.) or presence of ovarian cysts.
5. Known hypersensitivity or allergy to the active substances and/or any component of the product under investigation.
6. 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.
7. Participation in any clinical study that has been ongoing or concluded for less than three months.
8. Patient with one or more psychiatric disorders, such as alcoholism, substance abuse or addictive disorder, bipolar disorder, schizophrenia, or other personality disorders.
9. Patient who, in the opinion of the gynecologist, will not be able to meet the prerequisites required for this investigation.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

MetrioFen Gocce

Experimental group

Description:

EndOK Green contains EndoGen (TM)-an oral dose (10 drops per administration) twice daily of parsley extract, rosemary extract, other substances with Apigenin and Luteolin in hydro-alcoholic solution

Treatment:

Dietary Supplement: MetrioFen Gocce