Homeopathy for Post-operative (C. Section) Recovery

This study has been completed.
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00725569
First received: July 29, 2008
Last updated: October 18, 2009
Last verified: October 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analgesic Use [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Duration of Hospital Stay [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Time from Surgery to First Bowel Movement [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Blood Loss [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Quality of Life Assessment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Adverse Effects of Treatment [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Menachem Oberbaum, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00725569     History of Changes
Other Study ID Numbers: POR2008
Study First Received: July 29, 2008
Last Updated: October 18, 2009
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on October 01, 2014