Effect of atorvastatin on ulcer

Evaluation of therapeutic effects of topical atorvastatin in postoperative ulcers: A randomized triple-blind placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190810044500N3

Enrollment

Registered

2020-04-10

Start date

2019-11-13

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

Post-operative wounds.

Interventions

Intervention 1: Intervention group: Atorvastatin Emulgel. Intervention 2: Control group: Placebo Emulgel. Intervention 3: Intervention group: Atorvastatin Nano-Emulgel.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Candidates for laparotomy surgery over 18 years old Sufficient literacy to fill out a consent form, understand the study, use the drug, report pain and possible side effects

Exclusion criteria

Exclusion criteria: Pregnant and lactating women Patients with any peripheral or central neuropathic pain Patients with a history of psychosis Patients with a history of inflammatory disease who cannot discontinue NSAIDs or analgesics. Patients with oral atorvastatin

Design outcomes

Primary

Measure	Time frame
Redness. Timepoint: Before the start of the intervention - The first day -The seventh day -The fourteenth day. Method of measurement: Redness, Oedema, Ecchymosis, Discharge, Approximation (REEDA) scale.;Oedema. Timepoint: Before the start of the intervention - The first day -The seventh day -The fourteenth day. Method of measurement: REEDA Scale.;Ecchymosis. Timepoint: Before the start of the intervention - The first day -The seventh day -The fourteenth day. Method of measurement: REEDA Scale.;Wound Secretion. Timepoint: Before the start of the intervention - The first day -The seventh day -The fourteenth day. Method of measurement: REEDA Scale.;Approximation. Timepoint: Before the start of the intervention - The first day -The seventh day -The fourteenth day. Method of measurement: REEDA Scale.	—

Measure

Time frame

Redness. Timepoint: Before the start of the intervention - The first day -The seventh day -The fourteenth day. Method of measurement: Redness, Oedema, Ecchymosis, Discharge, Approximation (REEDA) scale.;Oedema. Timepoint: Before the start of the intervention - The first day -The seventh day -The fourteenth day. Method of measurement: REEDA Scale.;Ecchymosis. Timepoint: Before the start of the intervention - The first day -The seventh day -The fourteenth day. Method of measurement: REEDA Scale.;Wound Secretion. Timepoint: Before the start of the intervention - The first day -The seventh day -The fourteenth day. Method of measurement: REEDA Scale.;Approximation. Timepoint: Before the start of the intervention - The first day -The seventh day -The fourteenth day. Method of measurement: REEDA Scale.

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Secondary

Measure	Time frame
Quality of Life. Timepoint: On days 1, 7 and 14. Method of measurement: According to the Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30 (version 3).;Visual analog scale (VAS). Timepoint: baseline, days 1, 2, , and 14. Method of measurement: The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').;Unexpected adverse effects. Timepoint: At the end of the study. Method of measurement: Examining and asking the patient.	—

Measure

Time frame

Quality of Life. Timepoint: On days 1, 7 and 14. Method of measurement: According to the Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30 (version 3).;Visual analog scale (VAS). Timepoint: baseline, days 1, 2, , and 14. Method of measurement: The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').;Unexpected adverse effects. Timepoint: At the end of the study. Method of measurement: Examining and asking the patient.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Saghafi

Yazd University of Medical Sciences

F.saghafi@ssu.ac.ir+98 35 3820 3419

Outcome results

None listed

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