Homeopathic Treatment of Chronic Pelvic Pain in Women With Endometriosis
|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.|
|ClinicalTrials.gov Identifier: NCT02427386|
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : February 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis Pelvic Pain||Drug: dynamized estrogen Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Phase 4 Randomized Controlled Trial of Dynamized Estrogen in Individualized Homeopathic Treatment of Chronic Pelvic Pain of Endometriosis|
|Actual Study Start Date :||May 2014|
|Primary Completion Date :||February 2016|
|Study Completion Date :||December 2016|
Active Comparator: dynamized estrogen in alcohol solution
Dynamized estrogen (17-beta estradiol) in the 12cH, 24cH and 18cH potencies.
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
Placebo Comparator: placebo (alcohol solution)
This arm received alcohol solution during the 24-week study duration.
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
- 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)
- 36-Item Short-Form Health Survey (SF-36) [ Time Frame: 24 weeks (6 months) ]
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): NCT02427386
|Principal Investigator:||Marcus Z Teixeira, PhD||University of Sao Paulo General Hospital|