Homeopathy for Post-operative (C. Section) Recovery

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Cesarean Section

Clinical Trial Details

NCT number	NCT00725569
Study type	Interventional
Source	Shaare Zedek Medical Center
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	August 2008
Completion date	April 2009

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT03631329` - Predictability of Preoperative Carotid Artery Corrected Flow Time for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section
Completed	`NCT03244540` - Regional Analgesia After Cesarean Section	Phase 4
Active, not recruiting	`NCT03760718` - Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery	Early Phase 1
Active, not recruiting	`NCT04965779` - The Effect of Abdominal Binder Use on Postpartum Pain, Bleeding, and Breastfeeding Success in Cesarean Delivery Women	N/A
Terminated	`NCT01687972` - INSORB Versus Subcuticular Sutures at Cesarean Section	Phase 1
Withdrawn	`NCT01211431` - Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine	Phase 4
Completed	`NCT00991627` - Different Approaches to Maternal Hypotension During Cesarean Section	Phase 4
Completed	`NCT00987701` - Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors	N/A
Completed	`NCT01049477` - The Effects of Music Therapy on Women's Anxiety Before and During Cesarean Delivery	N/A
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Terminated	`NCT00386477` - Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial	N/A
Completed	`NCT00375986` - A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section	N/A
Completed	`NCT00517140` - Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function	N/A
Terminated	`NCT05051150` - Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Caesarean Section	Phase 4
Terminated	`NCT03695172` - Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section	Phase 4
Recruiting	`NCT06247852` - Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Completed	`NCT06012747` - Pain After Cesarean Section - A Danish Multicenter Cohort Study.
Not yet recruiting	`NCT05187520` - Naldebain for Control of Post-Cesarean Section Pain	Phase 2
Not yet recruiting	`NCT04999670` - Fascial Closure and Post-caesarean Pain	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.