Back to resultsEvaluation of a Nutraceutical for Endometriosis Pain Relief
Primary Purpose
Endometriosis
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Meta19.01
Sponsored by
About this trial
This is an interventional supportive care trial for Endometriosis
Eligibility Criteria
Inclusion Criteria:
- Confirmed endometriosis and/or Positive NMR
- 18-49y
- Mean pain score >6 on the assessment of pelvic pain (Visual analogue scale)
- Not eligible for surgery in the coming 3 months or had surgery >3 months before inclusion in the study
- >3 months intake of continue oral contraception (Oestrogen/Progesterone) before inclusion or no intake of oral contraception due to contraindication
- Has given voluntary, written, informed consent to participate in the study.
Exclusion Criteria:
- Planned surgery during study
- <3 month intake of continue oral contraception (Oestrogen/Progesterone) before inclusion
- Chronic inflammatory disease (Chron's disease, Rheumatism,..)
- Pregnancy
- Bariatric surgery
- Malabsorption issues
- Allergy or hypersensitivity to the study product:
- Fish and products thereof: fish oil
- Soybeans and products thereof
- Alcohol or substance abuse
- Start of gonadorelin analogue (ex. Busereline, Gosereline, triptoreline) therapy in the past 6 months
- Intake of other food supplements, including omega 3 and omega 6
- Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Sites / Locations
- CHU Ambroise Paré de Mons
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Specialized nutraceutical
Placebo
Arm Description
Specialized nutraceutical formulated in softgel. Participants are instructed to take 2 softgels orally with some water, one before breakfast and one before diner.
Identical placebo formulated without active ingredients in softgel. Participants are instructed to take 2 softgels orally with some water, one before breakfast and one before diner.
Outcomes
Primary Outcome Measures
Pain relief
pain relief monitored via the Assessment of Pelvic Pain (Visual Analogue scale, VAS) in the Endometriosis Health Profile 30 questions (EHP-30) at baseline and after 3 months of study product intake. The mean of all 3 VAS scales is taken to monitor the evolution of the pain of the subjects. Scores can be given from 0 to 10 with 0 as no pain and 10 as unbearable pain.
Secondary Outcome Measures
Inflammation marker C-reactive protein (CRP)
CRP will be measured at baseline and after 3 months of study product intake. High CRP values (>3mg/L) indicate inflammation while low CRP values (<1 mg/L) indicate no inflammation.
General well-being
The general well-being will be monitored via the Endometriosis Health Profile questionnaire with 30 questions (EHP-30) at baseline and after 3 months of product intake. These scales are transformed into a score from 0 to 100, in which 0 indicates a better health status, while 100 indicates a worse quality of life.
The need for analgesics
The need for analgesics while taking the study product will be monitored via an analgesic diary completed every time the subject takes pain medication. Over 3 months, the total need for analgesics per month will be counted and compared inbetween both groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04091191
Brief Title
Evaluation of a Nutraceutical for Endometriosis Pain Relief
Official Title
A Single Center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of a Specialized Nutraceutical for Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
October 13, 2021 (Actual)
Primary Completion Date
December 16, 2022 (Actual)
Study Completion Date
December 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Metagenics Europe
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Based on the EHP-30 questionnaire, the pain score and general well-being of all patients will be assessed with and without taking a specialized nutraceutical. These patients will be taking continuous oral contraception, for 3 months before inclusion till at least end of the study or not taking any oral contraception at all during the study due to contraindication(s).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Specialized nutraceutical
Arm Type
Active Comparator
Arm Description
Specialized nutraceutical formulated in softgel. Participants are instructed to take 2 softgels orally with some water, one before breakfast and one before diner.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical placebo formulated without active ingredients in softgel. Participants are instructed to take 2 softgels orally with some water, one before breakfast and one before diner.
Intervention Type
Dietary Supplement
Intervention Name(s)
Meta19.01
Intervention Description
A specialized nutraceutical containing plant extracts, vitamins and fish oil
Primary Outcome Measure Information:
Title
Pain relief
Description
pain relief monitored via the Assessment of Pelvic Pain (Visual Analogue scale, VAS) in the Endometriosis Health Profile 30 questions (EHP-30) at baseline and after 3 months of study product intake. The mean of all 3 VAS scales is taken to monitor the evolution of the pain of the subjects. Scores can be given from 0 to 10 with 0 as no pain and 10 as unbearable pain.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Inflammation marker C-reactive protein (CRP)
Description
CRP will be measured at baseline and after 3 months of study product intake. High CRP values (>3mg/L) indicate inflammation while low CRP values (<1 mg/L) indicate no inflammation.
Time Frame
3 months
Title
General well-being
Description
The general well-being will be monitored via the Endometriosis Health Profile questionnaire with 30 questions (EHP-30) at baseline and after 3 months of product intake. These scales are transformed into a score from 0 to 100, in which 0 indicates a better health status, while 100 indicates a worse quality of life.
Time Frame
3 months
Title
The need for analgesics
Description
The need for analgesics while taking the study product will be monitored via an analgesic diary completed every time the subject takes pain medication. Over 3 months, the total need for analgesics per month will be counted and compared inbetween both groups.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed endometriosis and/or Positive NMR
18-49y
Mean pain score >6 on the assessment of pelvic pain (Visual analogue scale)
Not eligible for surgery in the coming 3 months or had surgery >3 months before inclusion in the study
>3 months intake of continue oral contraception (Oestrogen/Progesterone) before inclusion or no intake of oral contraception due to contraindication
Has given voluntary, written, informed consent to participate in the study.
Exclusion Criteria:
Planned surgery during study
<3 month intake of continue oral contraception (Oestrogen/Progesterone) before inclusion
Chronic inflammatory disease (Chron's disease, Rheumatism,..)
Pregnancy
Bariatric surgery
Malabsorption issues
Allergy or hypersensitivity to the study product:
Fish and products thereof: fish oil
Soybeans and products thereof
Alcohol or substance abuse
Start of gonadorelin analogue (ex. Busereline, Gosereline, triptoreline) therapy in the past 6 months
Intake of other food supplements, including omega 3 and omega 6
Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaacoub Salame, MD
Organizational Affiliation
CHU Ambroise Paré de Mons
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Ambroise Paré de Mons
City
Mons
State/Province
Hainout
ZIP/Postal Code
7000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of a Nutraceutical for Endometriosis Pain Relief
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