Homeopathic Treatment of Chronic Pelvic Pain in Women With Endometriosis
|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|
|Actual Primary Completion Date :||February 2016|
|Actual 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) ]
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|