Skip to content

Comparison of Oral Passiflora Incarnata and Oxazepam on Preoperative Anxiety in Ambulatory Surgery Patients

Comparison of Oral Passiflora Incarnata and Oxazepam on Preoperative Anxiety in Ambulatory Surgery Patients: A Double Blind, Placebo Controlled Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013121315774N1
Enrollment
128
Registered
2014-04-12
Start date
2014-05-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Condition 1: Anxiety. Condition 2: Psychomotor function. Anxiety disorder, unspecified Dissociative motor disorders

Interventions

Intervention 1: Passiflora incarnata, 500 mg, ( PassipyTM IranDarouk) orally 120 min before surgery. Intervention 2: Oxazepam, 10 mg, orally, 120 min before surgery. Intervention 3: .
Treatment - Drugs
Treatment - Other
Oxazepam, 10 mg, orally, 120 min before surgery

Sponsors

Tehran University of Medical Sciences, Department of Anesthesiology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients referring to our anesthesia clinic, classified as American Society of Anesthesiologists (ASA) physical status of I or II, aged 18-60, who will be candidated for ambulatory inguinal herniorhaphy. Exclusion criteria: Patients with a history of anxiety disorders or consuming sedative, analgesic, antidepressant, or antiepileptic drugs; addict patients; patients with numerical rating scale (NRS) of less than one, for anxiety; Patients with any contraindications to the medications of study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Psychomotor function. Timepoint: ) at arrival in the operating room, and 90 min after tracheal extubation. Method of measurement: assessed with the Trieger Dot Test (TDT) and the Digit-Symbol Substitution Test (DSST).;Anxiety. Timepoint: 90 min before surgery and 90 min following premedication. Method of measurement: A numerical rating scale (NRS) for each patient to assess anxiety.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026