NCT06164613

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Universidad Nacional Autonoma de Honduras · Academic / Other
• Sex: Female
• Age: 14 Years – 45 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	Cinnamomum Verum oil extract	one capsule of 1000 mg orally of Cinnamomum Verum oil extract per day for 21-28 days
DRUG	Placebo	400 mg PO Canola oil soft gel capsule

Timeline

• Start date: 2023-12-04
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2023-12-11
• Last updated: 2025-12-04

Locations

1 site across 1 country: Honduras

Regulatory

• FDA-regulated drug study