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Therapeutic effect of ointment containing extract of Alkanna tinctoria plant in bedsores

Evaluating the therapeutic effects of a topical ointment containing the extract of Alkanna tinctoria in patients with bedsores: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181005041243N6
Enrollment
60
Registered
2024-11-28
Start date
2025-02-19
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

bedsore. Pressure ulcer

Interventions

Intervention 1: Intervention group: Ointment name: Alkana tinctoria, plant preparation: Medicinal plants are identified and prepared by a botanist. The rest of the materials are prepared and purchased

Sponsors

Iranian academic center for education culture and research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: age between 15 and 90 Grade 2 pressure ulcer with a diameter of less than 10 square centimeters

Exclusion criteria

Exclusion criteria: Patients with diabetes mellitus, AIDS, and other immunodeficiency diseases, like tuberculosis pregnancy Patients with wounds containing pus, bone impingement, visible bone, sepsis caused by wound infection, malignancy, connective tissue diseases, vasculitis, proven immune system disorder, corticosteroid use, chemotherapy and radiotherapy

Design outcomes

Primary

MeasureTime frame
Determining the extent of the wound. Timepoint: At the beginning of the study (before the start of the intervention) and 14 days after starting to use ointments. Method of measurement: The size of the wound is determined by a ruler.;Determining the time required to heal the wound. Timepoint: At the beginning of the study (before the start of the intervention) and 14 days after starting to use ointments. Method of measurement: The time required to heal the wound is determined by a doctor's visit.

Secondary

MeasureTime frame
Edema. Timepoint: At the beginning of the study (before the start of the intervention) and 30 days after starting to use ointments. Method of measurement: Based on the doctor's opinion, the presence or absence of edema is assessed.;Hematoma. Timepoint: At the beginning of the study (before the start of the intervention) and 30 days after starting to use ointments. Method of measurement: Based on the doctor's opinion, the presence or absence of hematoma is assessed.;Itching. Timepoint: At the beginning of the study (before the start of the intervention) and 30 days after starting to use ointments. Method of measurement: According to VAS, pruritus is measured from 0 (least) and 10 (most).;Pain. Timepoint: At the beginning of the study (before the start of the intervention) and 30 days after starting to use ointments. Method of measurement: According to VAS, pain is measured from 0 (least) and 10 (most).;Infection. Timepoint: At the beginning of the study (before the start of the intervention) and 30 days after starting to use ointments. Method of measurement: Based on the doctor's opinion, the presence or absence of infection is assessed.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Nasimi

Tehran University of Medical Sciences

m-nasimi@sina.tums.ac.ir+98 21 5563 0553

Outcome results

None listed

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