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The purpose of the research protocol is to evaluate the effectiveness of Cinnamomum verum extract for the initiation of labor. Cinnamaldehyde ((E)-3-Phenylprop-2-enal) is an α, β unsaturated aromatic aldehyde, derived from cinnamon (Cinnamomum Verum oil) used as a flavoring; It is a clear yellowish liquid substance, with a strong odor and flavor. It is the main component of cinnamon (63%), giving it its physicochemical properties. Cinnamon has been an element of empirical use for the beginning of labor, however, its effectiveness has not been demonstrated.
Cinnamon has been reported for its ethnopharmacological properties in pregnancy, being used to facilitate childbirth, as a lactagogue and for postpartum recovery. In Honduras, its use has been reported to relieve nausea and vomiting during pregnancy, to reduce abdominal pain. , reduction of lower limb edema, to relieve anxiety during labor, as well as a lactagogue without convergent opinions.
clinical trial of parallel groups of effectiveness, 2 groups will be taken, the intervention group will be administered capsules of Cinnamomum verum concentrate (1000 mg orally per day, a single dose) containing 67% cinnamaldehyde, one capsule per day will be administered (oral dose cinnamaldehyde lethal dose (LD50) of 1.15 g/kg), each capsule contains 1000 mg of Cinnamomum verum bark concentrate in soft gelatin capsules which are odorless and tasteless.
The control group will be administered canola oil capsules, a dose of 400 mg orally per day, a single dose per day. These soft gelatin capsules are odorless and tasteless.
Both capsules have identical physical characteristics. (they are soft gelatin capsules with the same color and smell)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 1000 mg orally of Cinnamomum Verum oil extract per day for 21-28 days |
|
| Placebo | Placebo Comparator | 400 mg orally of canola oil per day for 21-28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cinnamomum Verum oil extract | Drug | one capsule of 1000 mg orally of Cinnamomum Verum oil extract per day for 21-28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Onset of labor | change in the time of onset of physiological phase 3 of the uterus (onset of labor) | 21-28 days |
| Measure | Description | Time Frame |
|---|---|---|
| duration on labor | change in duration of labor | 24 hours |
| cesarean section and/or instrumental delivery | change in the rate of cesarean section and/or instrumental delivery |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ricardo A. Gutierrez Ramirez, MD, MSc | Contact | +50497546940 | ricardo.gutierrez@unah.edu.hn | |
| Yadira Diaz Tilguant, MD | Contact | +50488626004 | yadira.diaz@unah.edu.hn |
| Name | Affiliation | Role |
|---|---|---|
| Ricardo A. Gutierrez Ramirez, MD, MSc | Universidad Nacional Autonoma de Honduras | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Escuela | Recruiting | Tegucigalpa | Francisco Morazán Department | 11101 | Honduras |
all the results
1 year
web data base
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| ID | Term |
|---|---|
| D000074262 | Rapeseed Oil |
| ID | Term |
|---|---|
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 | Plant Preparations |
| D001688 |
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parallel group, efficacy, randomized, placebo-controlled, double-blind clinical trial.
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The masking of the treatment will be carried out by a person external to the study; in this sense, white bottles with orange and green labels will be used.
To mask the cinnamon smell of the capsule, the preparation in soft gelatin capsules with cinnamon oil will be used. This preparation, since the capsule is sealed, has no smell or flavor. For the placebo, soft gelatin capsules containing canola oil will be used.
| Placebo | Drug | 400 mg PO Canola oil soft gel capsule |
|
|
| 1-2 hours |
| Neonatal complications | change of neonatal complications (apgar less than 7 at 5 minutes, meconium aspiration syndrome) | 28 days |
| macrosomia | change in incidence of macrosomia | 1 hour |
| Biological Products |
| D045424 | Complex Mixtures |