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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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Female
Cesarean Section

Thank you

Trial Information

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


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

Type of Study:

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

Outcome Measure:

pain, to be evaluated using a numerical rating score (NRS) on a 100mm scale (0= no pain whatsoever, 100 = unbearable pain).

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

Menachem Oberbaum, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shaare Zedek Medical Center, Jerusalem, Israel

Authority:

Israel: Ministry of Health

Study ID:

POR2008

NCT ID:

NCT00725569

Start Date:

August 2008

Completion Date:

April 2009

Related Keywords:

  • Cesarean Section
  • Caesarian Section
  • Homeopathy
  • Pain
  • Analgesia

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