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Effect of Tranexamic Acid and Calcium Dobesilate for Bleeding of Endometrial Origin

NCT06707051 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-11-27

No results posted yet for this study

Summary

Abnormal uterine bleeding is characterized by excessive menstrual blood loss affecting over 50% of women of reproductive age. It can be debilitating and significantly affect a woman's quality of life. Tranexamic acid (TXA) prevents the breakdown of clots and fibrinolysis by binding to the lysine receptor on plasminogen while Calcium dobesilate improves microcirculation and vascular health by increasing nitric oxide synthesis leading to endothelium relaxation, so inhibits endothelial shedding. Calcium dobesilate and tranexamic acid have roles in managing bleeding disorders, but their use and efficacy can vary. Tranexamic acid is more established and widely used for abnormal bleeding, while calcium dobesilate role is less defined and more variable. Tranexamic acid reduces menstrual blood loss, but it has no affect on endothelium while calcium dobesilate reduces the oxidative stress , so improving endothelial health and provide the endothelial protection. Side effects include GI upset , hypersensitivity reactions and agranulocytosis. The side effects of both drugs are comparable.

Conditions

  • Heavy. Mentrual Bleeding
  • Abormal utèrine Bleeding
  • Bleeding
  • Uterine Bleeding
  • Hypersensitivity Response
  • GI Disturbance
  • Agranulocytosis
  • Bleeding Pattern
  • Endometrial
  • Endometrial Bleeding

Interventions

DRUG

Tranexamic Acid

Group A received Trannexamic Acid 500mg three times a day for 5 days

DRUG

Calcium dobesilate (Doxium)

Group B recieved Cap.Calcium Dobesilate 500mg 3 times a day for 5 days

Sponsors & Collaborators

  • District Headquarters Teaching Hospital Sahiwal

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-12-31
Completion
2024-06-30
FDA Drug
Yes

Countries

  • Pakistan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06707051 on ClinicalTrials.gov