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Completed

NCT Number: NCT00725569

Homeopathy for Post-operative (C. Section) Recovery

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • suspected/proven malignancy
  • underlying Axis-1 psychiatric illness
  • age < 18 years
  • diabetes mellitus (NIDDM/IDDM)
  • unable to comply with study proceedings

Treatment and study plan

Bellis perennis and Staphysagria (C6)

Drug

homeopathic remedy

Bellis perennis and Staphysagria (C30)

Drug

Homeopathic Remedy

Placebo

Drug

Placebo remedy, identical in size, shape and taste to treatment remedies

Primary outcomes

  1. 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 outcomes

  1. Analgesic Use

    Time frame: 4 weeks

  2. Duration of Hospital Stay

    Time frame: 4 weeks

  3. Time from Surgery to First Bowel Movement

    Time frame: 4 days

  4. Blood Loss

    Time frame: 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.

    Time frame: 4 weeks

  6. Quality of Life Assessment

    Time frame: 4 weeks

  7. Adverse Effects of Treatment

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 30, 2008
Registry last updated
Oct 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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