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Trial record 25 of 161 for:    turmeric

Flexofytol® for the Treatment of Endometriosis- Associated Pain (ENDOFLEX)

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: NCT04150406
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Alexandra Perricos, Medical University of Vienna

Brief Summary:

Endometriosis is a benign disease that affects 6-10% of women of reproductive age. The wide range of symptoms observed in patients with endometriosis is due to implantation of endometrial tissue outside the uterine cavity. This ectopic endometrium is subjected to cyclic changes similar to that of eutopic endometrium. Typically, ectopic lesions are found in the pelvis, notably on the ovaries in the form of cysts (endometriomas), as well as the rectouterine and vesicouterine pouch. Lesions have also been described in other parts of the abdomen and in other locations outside the abdominal cavity.

Although endometriosis has also been described in asymptomatic patients, possible symptoms range from mild to severe pain presenting itself as dysmenorrhea, dyspareunia, or dyschezia, or as infertility. Since the clinical picture varies, the treatment of this disease has become quite personalized. Many studies conducted over the past several years have presented different treatment options for the symptoms caused by endometriosis.

Turmeric, which is won from the rootstalks of Curcuma longa, has more than 300 biologically active elements. One of the three main curcuminoids that are derived from turmeric, is curcumin. Several in-vitro and animal studies have described anti-oxidant, anti-inflammatory and anti-angiogenic effects of curcumin.

The main objective for the treatment of endometriosis patients is symptom relief. Treatment options include analgesic therapies, hormonal therapies, laparoscopic surgery or a combination of these. For patients who refuse hormonal therapies however, conservative treatment options are limited.

Curcuma is a substance that has been in use for centuries, especially in ayurvedic and Traditional Chinese Medicine for the treatment of various symptoms, notably for pain alleviation in inflammatory illnesses. Several recently published studies have shown very promising results of Flexofytol for pain alleviation in patients with osteoarthritis, due to its anti-inflammatory and anti-oxidant properties. Due to these properties of curcuma, we aim to analyse if curcuma capsules, sold by the pharmaceutical company Tilman under the name Flexofytol®, can be used to alleviate symptoms in patients suffering from endometriosis.


Condition or disease Intervention/treatment Phase
Endometriosis Dietary Supplement: Flexofytol Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Flexofytol®, a Curcuma Extract, for the Treatment of Endometriosis- Associated Pain: a Randomized, Double Blind, Placebo-controlled Study
Actual Study Start Date : October 22, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Active Comparator: Flexofytol
2 capsules containing 42mg of curcumin will be administered twice a day for a duration of 4 months.
Dietary Supplement: Flexofytol
Curcuma extract

Placebo Comparator: Placebo
2 capsules of the placebo, identical in appearance to Flexofytol, will be administeres twice a day for a duration of 4 months.
Other: Placebo
placebo




Primary Outcome Measures :
  1. Change of the average pain score from baseline to 4 months after begin of treatment [ Time Frame: 4 months ]
    Pain will be evaluated using the Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).


Secondary Outcome Measures :
  1. Change in number of days with pain ≥ NRS 4 from baseline to 4 months after begin of treatment [ Time Frame: 4 months ]
    Pain will be evaluated using the Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).

  2. Alleviation of dyspareunia using the NRS between 0 and 10, from baseline to 4 months after begin of treatment points) [ Time Frame: 4 months ]
    Pain will be evaluated using the Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).

  3. Alleviation of dysuria using the NRS between 0 and 10 points, from baseline to 4 months after begin of treatment [ Time Frame: 4 months ]
    Pain will be evaluated using the Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).

  4. Alleviation of dyschezia using the NRS between 0 and 10 points from baseline to 4 months after begin of treatment [ Time Frame: 4 months ]
    Pain will be evaluated using the Numeric Rating Scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).

  5. Change in quality of life (using the numerical score of the Endometriosis health profile - EHP 30) [ Time Frame: 4 months ]
    evaluated using a scale of 0 - 100, where 0 indicates the best health status and 100 the worst health status

  6. Change in sexual function (using the numerical score of the female sexual function index - FSFI) [ Time Frame: 4 months ]
    each question answered using a score from 0 to 5, 0 indicating no sexual activity, and, depending on the question, 1 indicating high satisfaction or high frequency, to 5 indicating low satisfaction or low frequency.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 51 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premenopausal women between the ages of 18 and 51 years
  • Ability to comprehend the full nature and purpose of the study
  • Signed informed consent
  • Diagnosed endometriosis (peritoneal, ovarian or deep-infiltrating endometriosis (DIE))
  • By laparoscopy or laparotomy with histological verification diagnosed up to 10 years before screening
  • By ultrasound or MRI (ovarian or deep-infiltrating endometriosis, as peritoneal lesions can only be evaluated surgically)
  • Moderate to severe pelvic pain (i.e. dysmenorrhea or NMPP of at least 4 on the 1-10 NRS) at least during the past 3 months
  • Refusal of hormonal treatments
  • The patient must agree to switch from her usual analgesic rescue medication to only the one permitted by the study during screening, treatment and follow-up period

Exclusion Criteria:

  • The patient is pregnant or breast feeding or is planning a pregnancy within the treatment period
  • Known addiction (alcohol, drugs, pills, etc...)
  • Liver or kidney problems
  • Known problems of the bile system
  • Infection (HIV, Hepatitis, TBC, etc..) or systemic autoimmune diseases
  • Known or suspected malignant disease
  • Intake of blood-thinning medication (such as heparin or aspirin for example)
  • Intake of hormonal contraceptives (oral during the last 4 weeks, injectable: during the last 3 months)
  • Patient with a surgical history of hysterectomy, bilateral adnexectomy, endometrial ablation resulting in amenorrhea

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): NCT04150406


Contacts
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Contact: Alexandra Perricos, Dr. +4369918068650 alexandra.perricos@meduniwien.ac.at
Contact: René Wenzl, Prof. Dr. +4314040065190 rene.wenzl@meduniwien.ac.at

Locations
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Austria
General Hospital of Vienna, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: René Wenzl, Prof. Dr.         
Sponsors and Collaborators
Medical University of Vienna

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Responsible Party: Alexandra Perricos, Principal investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04150406    
Other Study ID Numbers: 1712/2019
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexandra Perricos, Medical University of Vienna:
Curcuma
Endometriosis-associated pain
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Turmeric extract
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs