Homeopathy for Post-operative (C. Section) Recovery

Shaare Zedek Medical Center

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cesarean Section

Treatments: Drug: Placebo; Drug: Bellis perennis and Staphysagria (C30); Drug: Bellis perennis and Staphysagria (C6)

Study type: Interventional

Funder types: Other

Identifiers

NCT00725569

POR2008

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

A

Active Comparator group

Description:

Bellis perennis and Staphysagria (C6)

Treatment:

Drug: Bellis perennis and Staphysagria (C6)

B

Active Comparator group

Description:

Bellis perennis and Staphysagria (C30)

Treatment:

Drug: Bellis perennis and Staphysagria (C30)

C

Placebo Comparator group

Description:

Placebo Remedy

Treatment:

Drug: Placebo