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Homeopathy for Post-operative (C. Section) Recovery

NCT00725569 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2009-10-20

No results posted yet for this study

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.

Conditions

  • Cesarean Section

Interventions

DRUG

Bellis perennis and Staphysagria (C6)

homeopathic remedy

DRUG

Bellis perennis and Staphysagria (C30)

Homeopathic Remedy

DRUG

Placebo

Placebo remedy, identical in size, shape and taste to treatment remedies

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Principal Investigators

  • Menachem Oberbaum, M.D. · Shaare Zedek Medical Center, Jerusalem, Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Israel

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00725569 on ClinicalTrials.gov