Shaare Zedek Medical Center
Jerusalem, 91031, Israel
NCT Number: NCT00725569
The planned study will be conducted in a prospective, randomized, double blind placebo controlled manner. Two "anti-traumatic" Homeopathic remedies (Arnica montana and Staphysagria) will be used. The selection of these remedies was based on a previous trial that showed a statistical difference in Hemoglobin levels favoring pregnant women treated with these drugs following delivery.
The proposed study will focus on the post-operative recovery of women undergoing Cesarean section. According to Homeopathic principles, these two remedies are believed to improve the "vital force", and will therefore improve convalescence following surgery in the study group. The study will include 90 women between the ages of 18 and 50 years who are scheduled for elective Cesarean Section. Exclusion criteria are: obesity (above 100kg), malignancy, psychiatric illness, diabetes and multipara pregnancies. Participants will be inducted following a detailed explanation by an MD and signing of an informed consent form, and then subdivided randomly into three groups numbering 30 in each: Two groups will be treated with homeopathic drugs of varied doses, and the third will get a placebo remedy which is indistinguishable from the other drugs. Outcome measures will include: 1. Blood loss - as estimated by a reduction in serum Hemoglobin levels. 2. Pain -to be evaluated by a numerical rating score (NRS) 3. Analgesic use 4. Length of post-operative stay and complications. 5. Quality of life outcomes - to be assessed using the MOS SF-36 questionnaire at one and four weeks following surgery. Although not expected, adverse events will be monitored.
If, as we anticipate, the homeopathic treatment proves to be both safe and effective in shortening the duration of post-operative healing, this will have significant implications, with respect to both healthcare costs and patient suffering. It will also open the door for further research in the field of trauma medicine, as well as other stress-related illness.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Phase 2 / Phase 3
Jerusalem, 91031, Israel
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
homeopathic remedy
Homeopathic Remedy
Placebo remedy, identical in size, shape and taste to treatment remedies
Time frame: 4 weeks
Time frame: 4 weeks
Time frame: 4 weeks
Time frame: 4 days
Time frame: 4 days
Time frame: 4 weeks
Time frame: 4 weeks
Time frame: 4 days
Shaare Zedek Medical Center
Other
Effect of Homeopathic Drugs Bellis Perennis ו- Staphysagria on the Post-operative Recovery, of Women Undergoing Cesarean Section- (an Exploratory) Double Blind, Placebo Controlled Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06824740
Agnosia, Analgesia
Barcelona, Catalonia, Spain
View Trial DetailsNCT02096003
Agnosia, Cesarean Section
New York, United States
View Trial DetailsNCT07720440
Agnosia, Behavior
Istanbul, Sultangazi, Turkey (Türkiye)
View Trial DetailsNCT07436520
Agnosia, Cesarean Section
Konya, Turkey (Türkiye)
View Trial Details