Using a Herbal Remedy Extract for the Treatment of Endometriosis Symptoms

NCT04493476 | Completed Phase 2

• 1 other identifier: 0206-19COM2
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 1.Study Group - Taking a daily dose of dietary supplement extract capsules
2. 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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Improvement in visual analogue scale pain scores in women with endometriosis symptoms treated with the herbal extract formula

  Improvement will be measured by statistically significant visual analogue scale score differences collected by daily patient questionnaires

  6 months

Secondary Outcomes (1)

• Improvement in quality of life followiing treatment with the herbal extract formula

  6 months

Study Arms (2)

Chineese Herbal formula

ACTIVE COMPARATOR

The study group will be given capsules containing Chinese herbal formula extract - Traditional Chinese MedicinalSubstances

Drug: Chinese herbal formula

placebo

PLACEBO COMPARATOR

The control group tested will receive placebo capsules. Containing starch.

Drug: Chinese herbal formula

Interventions

Chinese herbal formula DRUG

Chinese herbal formula

Chineese Herbal formula; placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with surgically diagnosed endometriosis and / or a clinical picture suitable for endometriosis.
• Age 18 to 45. The patient is capable and willing to agree in writing ICF to enter the study.
• There is no known allergy to any of the ingredients in the plant formula according to a sensitive patient's questioning.
• The patient agrees to use contraception during the study period until the end of the medication if hormone therapy is not taken.
• The patient has not changed / stopped / started hormone therapy in the previous three months of recruitment.

You may not qualify if:

• Treated with kidney or liver disease, severe cardiovascular disease, chronic pancreatitis, diabetes or gallstones.
• \. 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.
• \. Women who do not speak the Hebrew language about her ignorance

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Medical Center

Haifa, 34362, Israel

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr yuval kaufman. Senior surgeon in the Department of Obstetrics and Gynecology

Model Details: This is a prospective, placebo-controlled, double-blind randomized trial

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 30, 2020
• Study Start: October 1, 2020
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: June 26, 2025

Record last verified: 2020-07

Locations

IL (1)