Comparison the effect of the topical Plantago major hydro-alcoholic extract versus placebo on treatment of grade1 pressure ulcer in patients with paralysis secondary to brain stroke

Comparison the effect of the topical Plantago major hydro-alcoholic extract versus placebo on treatment of grade1 pressure ulcer in patients with paralysis secondary to brain stroke: a triple blind randomized clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201609209014N117

Enrollment

112

Registered

2016-09-22

Start date

2016-10-06

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

Stroke. Stroke, not specified as haemorrhage or infarction

Interventions

Intervention 1: Using topical Phenytoin cream 1% on the grade 1 pressure ulcers once a day for 2 weeks plus Plantago major hydro-alcoholic extract once a day for 2 weeks. Intervention 2: Using topical

Treatment - Drugs

Placebo

Using topical Phenytoin cream 1% on the grade 1 pressure ulcers once a day for 2 weeks plus Plantago major hydro-alcoholic extract once a day for 2 weeks

Using topical Phenytoin cream 1% on the grade 1 pressure ulcers once a day for 2 weeks plus placebo once a day for 2 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Complete bedrest patients with paralysis secondary to brain stroke; grade1 pressure ulcer. Exclusion criteria: Grade 2 pressure ulcer; sensitivity to Plantago and its products;

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Assessing the grade 2 pressure ulcer or higher grades. Timepoint: 2 weeks after treatment. Method of measurement: through physical examination.	—

Secondary

Measure	Time frame
Assessing local reactions such as rash, hives, or redness. Timepoint: 2 weeks after treatment. Method of measurement: through physical examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Niroomandi

Farshchian Hospital

zahra_niroomandi@yahoo.com+98 81 3827 4184

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 24, 2026