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Clinical evaluation of the effectiveness of a topical product prepared from cotton in stopping bleeding from the site of leech therapy

Preparation, characterization and clinical evaluation of the effectiveness of a cotton-based topical product in stopping bleeding from the leech therapy wound

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220625055267N1
Enrollment
20
Registered
2023-05-18
Start date
2023-07-23
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Bleeding from the site of leech therapy. Coagulation defect, unspecifiez, Haemorrhagic condition, unspecified

Interventions

Intervention 1: Intervention group: Dressing the site of leech therapy with a topical product based on cotton. Intervention 2: Control group: Dressing the site of leech therapy with routine dressing.

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adults who have leech therapy indication according to the doctor's opinion.

Exclusion criteria

Exclusion criteria: Clinical or laboratory evidence of coagulation disorder (ecchymosis, hematoma, petechiae purpura or disorder in PT, PTT, hemoglobin, platelets, glucose, calcium, urea, creatinine) Patients who take drugs that affect coagulability, including anti-platelets (aspirin, clopidogrel (Plavix), dipyridamole (Perzantin), ticlopidine (Ticlid), anticoagulants (warfarin, enoxaparin, rivaroxaban, heparin, streptokinase, etc.), blood thinners such as tranexamic acid, vitamin K, aminocaproic acid and statins and oral contraceptives and herbal anticoagulants such as products containing ginger and garlic ??????? ????? ???????? ??????? ????? ??? ITP? ??????? ? ????? ????? ??????? ???? ???? Patients with various malignancies Menstruating women Leech therapy in the face area Skin sensitivity to the product

Design outcomes

Primary

MeasureTime frame
The percentage of wounds whose bleeding will be completely stopped after local administration of the product. Timepoint: Fifteen minutes after using the product. Method of measurement: Monitoring bleeding from the site by clinical observation.

Secondary

MeasureTime frame
Clinical Bleeding from the site of leech therapy after the patient leaves the clinic. Timepoint: After leaving the clinic up to 72 hours after using the product. Method of measurement: Observing bleeding from the wound site.;Possible side effects caused by the administration of the product within 72 hours after the administration of the product. Timepoint: From the time of leaving the clinic until 72 hours later. Method of measurement: Reporting the complication by the patient.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Akbari

Mashhad University of Medical Sciences

akbarif981@mums.ac.ir+98 51 3884 8931

Outcome results

None listed

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