Homeopathy for Post-operative (C. Section) Recovery

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cesarean Section

Intervention / Treatment
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* Drug: Bellis perennis and Staphysagria (C6)
* Drug: Bellis perennis and Staphysagria (C30)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women hospitalized for elective C. Section, from the 1st to 3rd pregnancies. Age < 50 years Body weight < 100 kg Signing of informed consent form Exclusion Criteria: suspected/proven malignancy underlying Axis-1 psychiatric illness age < 18 years diabetes mellitus (NIDDM/IDDM) unable to comply with study proceedings

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Bellis perennis and Staphysagria (C6) | Drug: Bellis perennis and Staphysagria (C6)<br>* homeopathic remedy<br>|
| Active Comparator: B<br>Bellis perennis and Staphysagria (C30) | Drug: Bellis perennis and Staphysagria (C30)<br>* Homeopathic Remedy<br>|
| Placebo Comparator: C<br>Placebo Remedy | Drug: Placebo<br>* Placebo remedy, identical in size, shape and taste to treatment remedies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain, to be evaluated using a numerical rating score (NRS) on a 100mm scale (0= no pain whatsoever, 100 = unbearable pain). |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Quality of Life Assessment |  | 4 weeks | 
| Adverse Effects of Treatment |  | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caesarian Section, Homeopathy, Pain, Analgesia