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Completed

NCT Number: NCT06707051

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

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.

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Key information

Conditions

Heavy. Mentrual Bleeding Abormal utèrine Bleeding Agranulocytosis Bleeding Bleeding Pattern Cytopenia Endometrial Endometrial Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications GI Disturbance Genital Diseases Genital Diseases, Female Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hypersensitivity Response Leukocyte Disorders Leukopenia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Bleeding Uterine Diseases Uterine Hemorrhage

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sahiwal teaching Hospital Sahiwal

Sahiwal, Punjab Province, 57000, Pakistan

About this study

This Randomized control trial was conducted at Obstetrics & Gynaecology unit Sahiwal Teaching Hospital from to for the period of two years after taking the approval from Institutional review board (IRB). Sample size of one hundred patients (Fifty in each group) was calculated. These patients were randomly allocated into two equal groups, fifty patients in each group. Written informed consent was obtained from each subject by explaining the risks and benefits associated with the drugs. Group A women were given 500mg tranexamic acid thrice a day for 5 days during menstrual cycle and in group B women were given 500 mg capsule Calcium dobesilate thrice a day for 5 days during menstruation for consecutive time period of three months. Women were also evaluated for adverse effects. The information was entered into specially designed proformas. The data was analyzed by SPSS version 21.0. Frequencies and percentages of categorical variables including marital status, parity and adverse effects were calculated and compared between two groups by applying chi square tests. t-Test was used for the calculation of mean and standard deviations of numerical variables like age, BMI, duration of symptoms, blood loss before and after intervention and reduction in blood loss and was compared between two groups. In all statistical analysis only p value less than 0.05 was considered significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women of 18-40 years
  • Abnormal uterine bleeding

Exclusion criteria

  • Patients with pregnancy
  • Miscarriage
  • Hypersensitivity to pharmacological agents to be used in trial
  • Patients having moderate to severe anemia (Hb:<8gm/dl)
  • Patients with thyroid abnormalities (TSH > 5mIU)
  • Benign uterine conditions e.g. fibroid uterus, endometrial/cervical polyp
  • Uterine malignancy
  • Coagulation disorders (PT : >15sec).

Treatment and study plan

Tranexamic Acid

Drug

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

Calcium dobesilate (Doxium)

Drug

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

Primary outcomes

  1. Reduction in blood loss

    Time frame: Three months

    Blood loss at baseline and three months after treatment will measured. Reduction in blood loss will be calculated after three months of treatment

Sponsors and collaborators

Lead sponsor

District Headquarters Teaching Hospital Sahiwal

Other

Registry information

Official study title

Comparison of Efficacy of Tranexamic Acid and Calcium Dobesilate for Bleeding of Endometrial Origin

Acronym: TXA

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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