Homeopathy for Post-operative (C. Section) Recovery

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725569
• Other study ID #: POR2008
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 29, 2008
• Last updated: October 18, 2009
• Start date: August 2008
• Est. completion date: April 2009

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Drug:
• Bellis perennis and Staphysagria (C6)
homeopathic remedy
• Bellis perennis and Staphysagria (C30)
Homeopathic Remedy
• Placebo
Placebo remedy, identical in size, shape and taste to treatment remedies

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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