Homeopathy for Post-operative (C. Section) Recovery

• Sponsor: Shaare Zedek Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00725569
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Duration (Months): 8
• Patients Per Site Per Month: 11.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section	Drug: Bellis perennis and Staphysagria (C6); Drug: Bellis perennis and Staphysagria (C30); Drug: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A Bellis perennis and Staphysagria (C6)	Drug: Bellis perennis and Staphysagria (C6); homeopathic remedy
Active Comparator: B Bellis perennis and Staphysagria (C30)	Drug: Bellis perennis and Staphysagria (C30); Homeopathic Remedy
Placebo Comparator: C Placebo Remedy	Drug: Placebo; Placebo remedy, identical in size, shape and taste to treatment remedies

Outcome Measures

Primary Outcome Measures

1. 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

1. Analgesic Use [4 weeks]

2. Duration of Hospital Stay [4 weeks]

3. Time from Surgery to First Bowel Movement [4 days]

4. Blood Loss [4 days]

5. 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]

6. Quality of Life Assessment [4 weeks]

7. Adverse Effects of Treatment [4 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shaare Zedek Medical Center	Jerusalem		Israel	91031

Sponsors and Collaborators

• Shaare Zedek Medical Center

Investigators

• Principal Investigator: Menachem Oberbaum, M.D., Shaare Zedek Medical Center, Jerusalem, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00725569
• Other Study ID Numbers: POR2008
• First Posted: Jul 30, 2008
• Last Update Posted: Oct 20, 2009
• Last Verified: Oct 1, 2008

• Keywords provided by , ,: Caesarian Section; Homeopathy; Pain; Analgesia

Study Results

No Results Posted as of Oct 20, 2009