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NCT Number: NCT06164613

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

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.

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Key information

Age range

14 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

Location status: Recruiting

Location contact

Amanda Lopez Picado, Pharm.D, PhD

SUB_INVESTIGATOR

Maura C. Bustillo, MD

SUB_INVESTIGATOR

Ricardo A. Gutierrez Ramirez, MD

CONTACT

[email protected]

+50497546940

Ricardo A. Gutierrez Ramirez, MD, MSc

PRINCIPAL_INVESTIGATOR

Yadira Diaz Tilguant, MD

CONTACT

[email protected]

+50488626004

Yadira Diaz Tilguant, MD

SUB_INVESTIGATOR

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cinnamomum Verum oil extract

Drug

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

Other names: cinnamon oil

Placebo

Drug

400 mg PO Canola oil soft gel capsule

Other names: Canola oil, Kitchen oil

Primary outcomes

  1. Onset of labor

    Time frame: 21-28 days

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

Secondary outcomes

  1. duration on labor

    Time frame: 24 hours

    change in duration of labor

  2. cesarean section and/or instrumental delivery

    Time frame: 1-2 hours

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

  3. Neonatal complications

    Time frame: 28 days

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

  4. macrosomia

    Time frame: 1 hour

    change in incidence of macrosomia

Study contacts

Contact information is provided by the study sponsor or research team.

Ricardo A. Gutierrez Ramirez, MD, MSc

CONTACT

[email protected]

+50497546940

Yadira Diaz Tilguant, MD

CONTACT

[email protected]

+50488626004

Sponsors and collaborators

Lead sponsor

Universidad Nacional Autonoma de Honduras

Other

Registry information

Official study title

Use of Cinnamomum Verum Extract Versus Placebo for Induction of Labor and Reduction of Physiological Phase 2-3 of Labor. Double-blind Randomized Clinical Trial. CINNALAB TRIAL

Acronym: CINNALAB

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2023
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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