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EFFICACY OF PASSIFLORA INCARNATA (FLOWER PART) EXTRACT IN PARTICIPANTS WITH INSOMNIA DISORDER

Efficacy of Passiflora incarnata (flower part) extract in participants with insomnia disorder: A Randomized Controlled Trial

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250304004
Enrollment
44
Registered
2025-03-04
Start date
2025-03-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia Passiflora incarnata, Insomnia

Interventions

Passiflora incarnata flower extract 500 mg and a placebo containing anhydrous lactose 500 mg.,Anhydrous lactose
Passiflora incarnata (flower part),Placebo

Sponsors

Dhurakij Pundit University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of the International Classification of Sleep Disorders, Third Edition (ICSD-3). 2. Get more than 5 scores of Thai-Pittburgh Sleep Quality (T-PSQI).

Exclusion criteria

Exclusion criteria: 1. Have a history of using Benzodiazepine sedatives or other substances affecting sleep within the past month. 2. Have a medical condition or physical disorder that affects sleep. 3. Consume alcoholic beverages. 4. Have a history of cardiovascular disease. 5. Currently taking anticonvulsants, tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), antiplatelets, or anticoagulants. 6. Pregnant or planning to become pregnant during the study. 7. Breastfeeding. 7. Breastfeeding.

Design outcomes

Primary

MeasureTime frame
Sleep quality Day 15 and 30 T-PSQI

Secondary

MeasureTime frame
The safety of Passiflora incarnata Day 15 and 30 Patient reported outcome using a questionnaire interview

Countries

Thailand

Contacts

Public ContactManaporn Simachane

dhurakij pundit university

65130152@dpu.ac.th023838645

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026