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RecruitingNCT06164613CINNALABUpdated Dec 4, 2025

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

A Phase 2 interventional study of Cinnamomum Verum oil extract and Placebo in Labor Onset and Length Abnormalities and First Birth, sponsored by Universidad Nacional Autonoma de Honduras. Recruiting at 1 site in Honduras. Open to female participants aged 14 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by Universidad Nacional Autonoma de Honduras · Phase 2, Interventional, and Other

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 11 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
14 Years to 45 Years
Sex
Female
01

Study 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.

Read the detailed description

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)

02

Conditions studied

  • Labor Onset and Length Abnormalities
  • First Birth

Keywords

  • cinnamon oil, bark
  • labor onset
  • nulliparity
03

In context

Lead sponsor

Universidad Nacional Autonoma de Honduras is the lead sponsor of 13 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Intervention

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

    Drug: Cinnamomum Verum oil extract

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugCinnamomum Verum oil extract

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

    Also known as: cinnamon oil

  • DrugPlacebo

    400 mg PO Canola oil soft gel capsule

    Also known as: Canola oil, Kitchen oil

06

What researchers measure

Primary outcomes

  1. Onset of labor

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

    Time frame: 21-28 days

Secondary outcomes

  1. duration on labor

    change in duration of labor

    Time frame: 24 hours

  2. cesarean section and/or instrumental delivery

    change in the rate of cesarean section and/or instrumental delivery

    Time frame: 1-2 hours

  3. Neonatal complications

    change of neonatal complications (apgar less than 7 at 5 minutes, meconium aspiration syndrome)

    Time frame: 28 days

  4. macrosomia

    change in incidence of macrosomia

    Time frame: 1 hour

07

Study locations

1 of 1 sites recruiting
  • Hospital Escuela
    Tegucigalpa, Francisco Morazán Department 11101, Honduras
    Recruiting
    • Ricardo A. Gutierrez Ramirez, MD · Contactricardo.gutierrez@unah.edu.hn · +50497546940
    • Yadira Diaz Tilguant, MD · Contactyadira.diaz@unah.edu.hn · +50488626004
    • Ricardo A. Gutierrez Ramirez, MD, MSc · Principal investigator
    • Yadira Diaz Tilguant, MD · Sub investigator
    • Maura C. Bustillo, MD · Sub investigator
    • Amanda Lopez Picado, Pharm.D, PhD · Sub investigator
08

References and documents

Individual participant data

Plan to share: Yes — all the results

Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code

Time frame: 1 year

Access criteria: web data base

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06164613
Lead sponsor
Universidad Nacional Autonoma de Honduras
Responsible party
Ricardo A Gutierrez Ramirez, MD, MSc, FACOG (Professor, research coordinator of the postgraduate course in gynecology and obstetrics, Universidad Nacional Autonoma de Honduras) — Principal investigator
First posted
Dec 11, 2023
Start date
Dec 4, 2023
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Dec 4, 2025

Study contacts

Ricardo A. Gutierrez Ramirez, MD, MSc
Contact
ricardo.gutierrez@unah.edu.hn
+50497546940
Yadira Diaz Tilguant, MD
Contact
yadira.diaz@unah.edu.hn
+50488626004
Ricardo A. Gutierrez Ramirez, MD, MSc
principal investigator · Universidad Nacional Autonoma de Honduras

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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