Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial

NCT06164613 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CV-LT-01-2023
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

First Birth; Labor Onset and Length Abnormalities

Keywords

cinnamon oil, bark; labor onset; nulliparity

Outcome Measures

Primary Outcomes (1)

• Onset of labor

  change in the time of onset of physiological phase 3 of the uterus (onset of labor)

  21-28 days

Secondary Outcomes (4)

• duration on labor

  24 hours

• cesarean section and/or instrumental delivery

  1-2 hours

• Neonatal complications

  28 days

• macrosomia

  1 hour

Study Arms (2)

Intervention

EXPERIMENTAL

1000 mg orally of Cinnamomum Verum oil extract per day for 21-28 days

Drug: Cinnamomum Verum oil extract

Placebo

PLACEBO COMPARATOR

400 mg orally of canola oil per day for 21-28 days

Drug: Placebo

Interventions

Cinnamomum Verum oil extract DRUG

one capsule of 1000 mg orally of Cinnamomum Verum oil extract per day for 21-28 days

Also known as: cinnamon oil

Intervention

Placebo DRUG

400 mg PO Canola oil soft gel capsule

Also known as: Canola oil, Kitchen oil

Placebo

Eligibility Criteria

• Age: 14 Years - 45 Years
• Gender Eligibility Details: Pregnancy
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Delivery of an informed consent form signed and dated by parents or guardian and patient
• Declared willingness to comply with all study procedures and availability for the duration of the study.
• provision of appropriate consent and assent
• Willingness and ability to participate in study procedures
• Patients under 18 years of age
• Full-term pregnancies (37-41 Weeks of Gestation).
• Nulliparity
• Have your own cell phone
• Know how to read and write
• Residing in Tegucigalpa
• Be in good general health, as evidenced by your medical history
• Ultrasound with amniotic fluid index \> 5 cm
• Non Stress Test Reactive
• Ability to take oral medication and be willing to comply with the cinnamon capsule regimen

You may not qualify if:

• Current use of antihypertensive or hypoglycemic medications
• Presence of non-curable chronic diseases prior to pregnancy or during pregnancy such as hypertension, diabetes, hypothyroidism
• Premature rupture of membranes
• Infections (urinary tract infection, chorioamnionitis) present at the time of the study (diagnosed with symptoms or leukocytes \>12,500 or pathological urine examination)
• Allergies to cinnamaldehyde or cinnamon, canola oil
• Multiple pregnancy
• Major fetal malformations
• Fetal death
• Non-cephalic presentation
• Severe oligohydramnios (amniotic fluid index \< 2 cm)
• Having consumed or being consuming cinnamon products 7 days before the start of the study
• Febrile illness within 7 days before starting to take cinnamon
• Treatment with another investigational drug or other intervention within 7 days prior to the start of the intervention
• Current smoker or tobacco use

Sponsors & Collaborators

• Universidad Nacional Autonoma de Honduras: lead

Study Sites (1)

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

RECRUITING

MeSH Terms

Interventions

Rapeseed Oil

Intervention Hierarchy (Ancestors)

Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Ricardo A. Gutierrez Ramirez, MD, MSc

  Universidad Nacional Autonoma de Honduras

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo A. Gutierrez Ramirez, MD, MSc

CONTACT

+50497546940; ricardo.gutierrez@unah.edu.hn

Yadira Diaz Tilguant, MD

CONTACT

+50488626004; yadira.diaz@unah.edu.hn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, research coordinator of the postgraduate course in gynecology and obstetrics

Model Details: parallel group, efficacy, randomized, placebo-controlled, double-blind clinical trial.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: December 4, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 1 year
• Access Criteria: web data base

Locations

HO (1)