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Homeopathy for Post-operative (C. Section) Recovery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00725569
First Posted: July 30, 2008
Last Update Posted: October 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shaare Zedek Medical Center
  Purpose

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 Intervention Phase
Cesarean Section Drug: Bellis perennis and Staphysagria (C6) Drug: Bellis perennis and Staphysagria (C30) Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • pain, to be evaluated using a numerical rating score (NRS) on a 100mm scale (0= no pain whatsoever, 100 = unbearable pain). [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Analgesic Use [ Time Frame: 4 weeks ]
  • Duration of Hospital Stay [ Time Frame: 4 weeks ]
  • Time from Surgery to First Bowel Movement [ Time Frame: 4 days ]
  • Blood Loss [ Time Frame: 4 days ]
  • 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. [ Time Frame: 4 weeks ]
  • Quality of Life Assessment [ Time Frame: 4 weeks ]
  • Adverse Effects of Treatment [ Time Frame: 4 days ]

Estimated Enrollment: 90
Study Start Date: August 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00725569


Locations
Israel
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
  More Information

Responsible Party: Dr. Menachem Oberbaum, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00725569     History of Changes
Other Study ID Numbers: POR2008
First Submitted: July 29, 2008
First Posted: July 30, 2008
Last Update Posted: October 20, 2009
Last Verified: October 2008

Keywords provided by Shaare Zedek Medical Center:
Caesarian Section
Homeopathy
Pain
Analgesia