Using a Herbal Remedy Extract for the Treatment of Endometriosis Symptoms

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

A prospective, double-blind, placebo-controlled trial examining the effect of Chinese herbal medicine combined with curcumin defined as a dietary supplement on a study group of women with endometriosis, compared to control group.

research product:Chinese herbal extract and curcumin extract, which appear as nutritional supplements in the Ministry of Health database, the research product is packed in 800mg capsules.

Intended use: Composition of 14 different nutritional supplements, in Chinese herbal formula, for the treatment of endometriosis and its symptoms. The formula is formulated according to Chinese medicine principles and aims to reduce inflammation of the pelvic organs and reduce the levels of pain caused by endometriosis disease.

Objectives:Examine the Effect of Using Nutritional Supplements on Symptoms in Patients with Targeted Endometriosis Symptoms.

Primary Endpoints:

Benefit of pain in women suffering from symptoms of endometriosis patients taking herbal extract for 4 months of treatment.

Structure of the study:A prospective, double-blind, double-blind, placebo-controlled (randomized) placebo-controlled trial involving women suffering from endometriosis symptoms and meeting the inclusion and exclusion criteria and who agreed to participate in the study. The women will be randomly divided into the following two arms:

1. Study Group - Taking a daily dose of dietary supplement extract capsules

2. Control group - take a daily dose of Invo capsules Treatment efficacy will be measured according to a dedicated patient questionnaire with endometriosis symptoms that assess quality of life measures.

The study population will include 60 symptomatic women treated at the Multidisciplinary Center for Endometriosis Therapy at Lynn Medical Center.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carmel Medical Center

Criteria

Inclusion Criteria:

1. Women with surgically diagnosed endometriosis and / or a clinical picture suitable for endometriosis.

2. Age 18 to 45. The patient is capable and willing to agree in writing ICF to enter the study.

3. There is no known allergy to any of the ingredients in the plant formula according to a sensitive patient's questioning.

4. The patient agrees to use contraception during the study period until the end of the medication if hormone therapy is not taken.

5. The patient has not changed / stopped / started hormone therapy in the previous three months of recruitment.

Exclusion Criteria:

Treated with kidney or liver disease, severe cardiovascular disease, chronic pancreatitis, diabetes or gallstones.

2. Treated with another cause of pain known. 3. Treated during pregnancy or breastfeeding.

4. A patient who is unable or unwilling to agree in writing for inclusion in the study.

5. Allergy is known to be one of the ingredients in the plant formula. 6. A patient who started hormone therapy, changed hormone therapy, or stopped in the three months prior to recruiting for the study.

7. Women who do not speak the Hebrew language about her ignorance