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Using a Herbal Remedy Extract for the Treatment of Endometriosis Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04493476
Recruitment Status : Not yet recruiting
First Posted : July 30, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Yuval Kauffman, Carmel Medical Center

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. 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.


Condition or disease Intervention/treatment Phase
Endometriosis Drug: Chinese herbal formula Phase 2

Show Show detailed description

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Study Type : Interventional
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective, placebo-controlled, double-blind randomized trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Using a Herbal Remedy Extract for the Treatment of Endometriosis Symptoms
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Active Comparator: Chineese Herbal formula
The study group will be given capsules containing Chinese herbal formula extract - Traditional Chinese MedicinalSubstances
Drug: Chinese herbal formula
Chinese herbal formula

Placebo Comparator: placebo
The control group tested will receive placebo capsules. Containing starch.
Drug: Chinese herbal formula
Chinese herbal formula




Primary Outcome Measures :
  1. Improvement in visual analogue scale pain scores in women with endometriosis symptoms treated with the herbal extract formula [ Time Frame: 6 months ]
    Improvement will be measured by statistically significant visual analogue scale score differences collected by daily patient questionnaires


Secondary Outcome Measures :
  1. Improvement in quality of life followiing treatment with the herbal extract formula [ Time Frame: 6 months ]
    Statistically significant changes in QOL questionnaire scores and decrease in use of analgesics



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04493476


Contacts
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Contact: Yuval Kaufman, Dr 972-4-9551028 mdykaufman@clalit.org.il
Contact: hila kfir 972-523313350 hila_kf@clalit.org.il

Sponsors and Collaborators
Carmel Medical Center
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Responsible Party: Yuval Kauffman, Dr yuval kaufman. Senior surgeon in the Department of Obstetrics and Gynecology, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT04493476    
Other Study ID Numbers: 0206-19COM2
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis