Homeopathy for Post-operative (C. Section) Recovery
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
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2008
CompletedFirst Posted
Study publicly available on registry
July 30, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedOctober 20, 2009
October 1, 2008
8 months
July 29, 2008
October 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain, to be evaluated using a numerical rating score (NRS) on a 100mm scale (0= no pain whatsoever, 100 = unbearable pain).
4 weeks
Secondary Outcomes (7)
Analgesic Use
4 weeks
Duration of Hospital Stay
4 weeks
Time from Surgery to First Bowel Movement
4 days
Blood Loss
4 days
Post-operative Complications the following complications will be noted: Nausea, vomiting, abdominal distension, fever, urinary tract infection, thrombophlebitis, wound infection, wound hematoma, ileus, vaginal bleeding.
4 weeks
- +2 more secondary outcomes
Study Arms (3)
A
ACTIVE COMPARATORBellis perennis and Staphysagria (C6)
B
ACTIVE COMPARATORBellis perennis and Staphysagria (C30)
C
PLACEBO COMPARATORPlacebo Remedy
Interventions
Eligibility Criteria
You may qualify if:
- women hospitalized for elective C. Section, from the 1st to 3rd pregnancies.
- Age \< 50 years
- Body weight \< 100 kg
- Signing of informed consent form
You may not qualify if:
- suspected/proven malignancy
- underlying Axis-1 psychiatric illness
- age \< 18 years
- diabetes mellitus (NIDDM/IDDM)
- unable to comply with study proceedings
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Related Publications (1)
Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
PMID: 32871021DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Menachem Oberbaum, M.D.
Shaare Zedek Medical Center, Jerusalem, Israel
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 29, 2008
First Posted
July 30, 2008
Study Start
August 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
October 20, 2009
Record last verified: 2008-10