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Homeopathic Treatment of Chronic Pelvic Pain in Women With Endometriosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02427386
First Posted: April 28, 2015
Last Update Posted: February 24, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Marcus Zulian Teixeira, University of Sao Paulo General Hospital
April 22, 2015
April 28, 2015
February 24, 2017
May 2014
February 2016   (Final data collection date for primary outcome measure)
chronic pelvic pain (measured by visual analog scale (VAS-Pain) [ Time Frame: 24 weeks (6 months) ]
chronic pelvic pain (dysmenorrhoea, dyspareunia, acyclic pelvic pain depth, cyclic intestinal change and cyclic urinary change) measured by visual analog scale (VAS-Pain)
Same as current
Complete list of historical versions of study NCT02427386 on ClinicalTrials.gov Archive Site
36-Item Short-Form Health Survey (SF-36) [ Time Frame: 24 weeks (6 months) ]
Same as current
Not Provided
Not Provided
 
Homeopathic Treatment of Chronic Pelvic Pain in Women With Endometriosis
Phase 4 Randomized Controlled Trial of Dynamized Estrogen in Individualized Homeopathic Treatment of Chronic Pelvic Pain of Endometriosis
Endometriosis is a chronic inflammatory disease that causes pelvic pain difficult to treat. In view of this, many patients seek assistance in complementary and alternative medicine, including homeopathic treatment. The absence of evidence in the literature raises controversy about the effectiveness of homeopathic treatment in endometriosis. The aim of this randomized trial is to evaluate the effectiveness of dynamized estrogen compared to placebo in the treatment of chronic pelvic pain of endometriosis.
This is a randomized, double-blind and placebo controlled trial using individualised homeopathic medicine (dynamized estrogen) to treat chronic pelvic pain of endometriosis. Patients with endometriosis, chronic pelvic pain and a set of signs and symptoms similar to those of the estrogen adverse events will be recruited in the Sector of Endometriosis of the Clinical Division of Gynaecological of the Hospital das Clínicas of the Faculty of Medicine of the University of Sao Paulo. The selection process was carried out through the analysis of medical charts and self-completing of structured questionnaires. Satisfied the inclusion criteria, fifty patients were randomly and distributed to receive dynamized estrogen or placebo. The primary clinical outcome is the severity of the chronic pelvic pain. Statistical analysis will be by intention-to-treat and per protocol comparing homeopathic drug with placebo after 24 weeks of intervention.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Endometriosis
  • Pelvic Pain
  • Drug: dynamized estrogen
    The dosage of the homeopathic medicine or placebo will be of 3 drops, 2 times a day throughout the period of study, and can be reduced in case of finding of homeopathic aggravation of symptoms. 30 ml bottles will be sufficient for the proposed dosage every 8 weeks of treatment (bimensal period).
    Other Name: dynamized 17-beta estradiol
  • Drug: placebo
    The dosage of the placebo (alcohol solution) will be of 3 drops, 2 times a day throughout the period of study.
    Other Name: alcohol solution
  • Active Comparator: dynamized estrogen in alcohol solution
    Dynamized estrogen (17-beta estradiol) in the 12cH, 24cH and 18cH potencies.
    Intervention: Drug: dynamized estrogen
  • Placebo Comparator: placebo (alcohol solution)
    This arm received alcohol solution during the 24-week study duration.
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2016
February 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

primary inclusion criteria:

  • aged between 18 and 45;
  • diagnosis of endometriosis (endometrial ectopia) confirmed by imaging test (MRI or TVUS) or laparoscopy (biopsy);
  • chronic pelvic pain refractory to conventional hormone treatments and with intensity ≥ 5 on the visual analog pain scale (VAS-Pain: 0-10 points);

secondary inclusion criteria:

  • symptomatic individualization of patients according to adverse events of estrogen (minimum syndrome of maximum value).

Exclusion Criteria:

  • absence of clinical and laboratory diagnosis of menopause or
  • premature ovarian failure
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02427386
FMUSP
Yes
Not Provided
Plan to Share IPD: Undecided
Marcus Zulian Teixeira, University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
Not Provided
Principal Investigator: Marcus Z Teixeira, PhD University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP