Cesarean Section Clinical Trial
Official title:
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
Verified date | October 2008 |
Source | Shaare Zedek Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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: 1. suspected/proven malignancy 2. underlying Axis-1 psychiatric illness 3. age < 18 years 4. diabetes mellitus (NIDDM/IDDM) 5. unable to comply with study proceedings |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Shaare Zedek Medical Center | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Shaare Zedek Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain, to be evaluated using a numerical rating score (NRS) on a 100mm scale (0= no pain whatsoever, 100 = unbearable pain). | 4 weeks | No | |
Secondary | Analgesic Use | 4 weeks | No | |
Secondary | Duration of Hospital Stay | 4 weeks | No | |
Secondary | Time from Surgery to First Bowel Movement | 4 days | No | |
Secondary | Blood Loss | 4 days | Yes | |
Secondary | 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 | Yes | |
Secondary | Quality of Life Assessment | 4 weeks | No | |
Secondary | Adverse Effects of Treatment | 4 days | Yes |
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