Labor Onset and Length AbnormalitiesPhase 2CINNALABNCT06164613
Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial
A Phase 2 study testing Cinnamomum Verum oil extract in people with Labor Onset and Length Abnormalities and First Birth, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Onset and Length Abnormalities, First Birth
- What is being tested?
- Cinnamomum Verum oil extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteHonduras
- Study dates
- 4 Dec 2023to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 14 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Honduras1 site, 1 recruiting
- Recruiting
Hospital Escuela
Tegucigalpa, Francisco Morazán Department, 11101
Ricardo A. Gutierrez Ramirez, MD, +50497546940, ricardo.gutierrez@unah.edu.hn
Yadira Diaz Tilguant, MD, +50488626004, yadira.diaz@unah.edu.hn
About this study
Official 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
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)
- Conditions
- Labor Onset and Length Abnormalities, First Birth
- Being tested
- Cinnamomum Verum oil extract, Placebo
- Keywords
- cinnamon oil, bark, labor onset, nulliparity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinnamomum Verum oil extractDrug
Also called cinnamon oil
one capsule of 1000 mg orally of Cinnamomum Verum oil extract per day for 21-28 days
PlaceboDrug
Also called Canola oil, Kitchen oil
400 mg PO Canola oil soft gel capsule
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 1000 mg orally of Cinnamomum Verum oil extract per day for 21-28 days Receives: Drug: Cinnamomum Verum oil extract |
| Placebo | Placebo comparator | 400 mg orally of canola oil per day for 21-28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of labor
change in the time of onset of physiological phase 3 of the uterus (onset of labor)
Measured: 21-28 days
Secondary outcomes (4)
duration on labor
change in duration of labor
Measured: 24 hours
cesarean section and/or instrumental delivery
change in the rate of cesarean section and/or instrumental delivery
Measured: 1-2 hours
Neonatal complications
change of neonatal complications (apgar less than 7 at 5 minutes, meconium aspiration syndrome)
Measured: 28 days
macrosomia
change in incidence of macrosomia
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start4 Dec 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor Onset and Length AbnormalitiesStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel group, efficacy, randomized, placebo-controlled, double-blind clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Honduras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras
- Investigators
- Ricardo A. Gutierrez Ramirez, MD, MSc, Principal investigator, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164613
- Sponsor's protocol ID
- CV-LT-01-2023
- Acronym
- CINNALAB
- Status last verified
- Nov 2025
- First submitted
- 1 Dec 2023
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: all the results
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06164613
- Acronym / sponsor ID
- CINNALAB / CV-LT-01-2023
- Conditions
- Labor Onset and Length Abnormalities, First Birth
- Keywords
- cinnamon oil, bark, labor onset, nulliparity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de HondurasUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Dec 2023 (actual)
- 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 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.
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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- parallel group, efficacy, randomized, placebo-controlled, double-blind clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Cinnamomum Verum oil extract1000 mg orally of Cinnamomum Verum oil extract per day for 21-28 days |
| Placebo | Placebo comparator | Drug: Placebo400 mg orally of canola oil per day for 21-28 days |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Cinnamomum Verum oil extractAlso: cinnamon oilone capsule of 1000 mg orally of Cinnamomum Verum oil extract per day for 21-28 days | Drug | Intervention |
| PlaceboAlso: Canola oil, Kitchen oil400 mg PO Canola oil soft gel capsule | Drug | Placebo |
Primary outcome
Onset of labor
Time frame: 21-28 days
change in the time of onset of physiological phase 3 of the uterus (onset of labor)
4 secondary outcomes
duration on labor
Time frame: 24 hours
cesarean section and/or instrumental delivery
Time frame: 1-2 hours
Neonatal complications
Time frame: 28 days
macrosomia
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: Yes. all the results
Related trials for Labor Onset and Length Abnormalities
Recruiting
The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
Labor Dystocia, Labor Complication
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.
Ricardo A. Gutierrez Ramirez, MD, MSc principal investigator
Universidad Nacional Autonoma de Honduras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cinnamomum Verum oil extract in people with Labor Onset and Length Abnormalities and First Birth, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
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 14 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. 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 Honduras. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo A. Gutierrez Ramirez, MD, MSc (+50497546940, ricardo.gutierrez@unah.edu.hn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of labor (time frame: 21-28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2025.