Cesarean SectionPhase 2/3NCT00725569
Homeopathy for Post-operative (C. Section) Recovery
A Phase 2/3 study testing Bellis perennis and Staphysagria (C6) and Bellis perennis and Staphysagria (C30) in people with Cesarean Section, run by Shaare Zedek Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Bellis perennis and Staphysagria (C6) and Bellis perennis and Staphysagria (C30)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2008to Apr 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women hospitalized for elective C. Section, from the 1st to 3rd pregnancies.
- Age < 50 years
- Body weight < 100 kg
- Signing of informed consent form
Who cannot join
- suspected/proven malignancy
- underlying Axis-1 psychiatric illness
- age < 18 years
- diabetes mellitus (NIDDM/IDDM)
- unable to comply with study proceedings
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Cesarean Section
- Being tested
- Bellis perennis and Staphysagria (C6), Bellis perennis and Staphysagria (C30), Placebo
- Keywords
- Caesarian Section, Homeopathy, Pain, Analgesia
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bellis perennis and Staphysagria (C6)Drug
homeopathic remedy
Bellis perennis and Staphysagria (C30)Drug
Homeopathic Remedy
PlaceboDrug
Placebo remedy, identical in size, shape and taste to treatment remedies
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Bellis perennis and Staphysagria (C6) Receives: Drug: Bellis perennis and Staphysagria (C6) |
| B | Active comparator | Bellis perennis and Staphysagria (C30) Receives: Drug: Bellis perennis and Staphysagria (C30) |
| C | Placebo comparator | Placebo Remedy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain, to be evaluated using a numerical rating score (NRS) on a 100mm scale (0= no pain whatsoever, 100 = unbearable pain).
Measured: 4 weeks
Secondary outcomes (7)
Analgesic Use
Measured: 4 weeks
Duration of Hospital Stay
Measured: 4 weeks
Time from Surgery to First Bowel Movement
Measured: 4 days
Blood Loss
Measured: 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.
Measured: 4 weeks
Quality of Life Assessment
Measured: 4 weeks
Adverse Effects of Treatment
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Menachem Oberbaum, M.D., Principal investigator, Shaare Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725569
- Sponsor's protocol ID
- POR2008
- Status last verified
- Oct 2008
- First submitted
- 29 Jul 2008
- Last updated
- 20 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
PubMed 32871021
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00725569
- Acronym / sponsor ID
- POR2008
- Conditions
- Cesarean Section
- Keywords
- Caesarian Section, Homeopathy, Pain, Analgesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Bellis perennis and Staphysagria (C6)Bellis perennis and Staphysagria (C6) |
| B | Active comparator | Drug: Bellis perennis and Staphysagria (C30)Bellis perennis and Staphysagria (C30) |
| C | Placebo comparator | Drug: PlaceboPlacebo Remedy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women hospitalized for elective C. Section, from the 1st to 3rd pregnancies.
- Age < 50 years
- Body weight < 100 kg
- Signing of informed consent form
Key exclusion criteria (5 listed)
- suspected/proven malignancy
- underlying Axis-1 psychiatric illness
- age < 18 years
- diabetes mellitus (NIDDM/IDDM)
- unable to comply with study proceedings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bellis perennis and Staphysagria (C6)homeopathic remedy | Drug | A |
| Bellis perennis and Staphysagria (C30)Homeopathic Remedy | Drug | B |
| PlaceboPlacebo remedy, identical in size, shape and taste to treatment remedies | Drug | C |
Primary outcome
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2009.
- Derived from this study: PubMed 32871021Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
Related trials for Cesarean Section
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Prevalence of Pain During Cesarean Section
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Lateral QL Block vs Intrathecal Morphine for Cesarean Section
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Sustained Cord Circulation at Emergency Cesarean Section
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Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Menachem Oberbaum, M.D. principal investigator
Shaare Zedek Medical Center, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bellis perennis and Staphysagria (C6) and Bellis perennis and Staphysagria (C30) in people with Cesarean Section, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00725569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2009.