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

Phase 2

Completed

• Conditions: Heavy. Mentrual Bleeding; Abormal utèrine Bleeding; Bleeding; Uterine Bleeding; Hypersensitivity Response; GI Disturbance; Agranulocytosis; Bleeding Pattern; Endometrial Bleeding; Endometrial
• Interventions: Drug: Tranexamic Acid; Drug: Calcium dobesilate (Doxium)

• Registration Number: NCT06707051
• Lead Sponsor: District Headquarters Teaching Hospital Sahiwal

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30
• Study First Submitted: 2024-10-27
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Tranexamic Acid	Group A included 50 Patients fulfilling the inclusion and exclusion criteria, was given Tranexamic acid for bleeding of endometrial origin
Group B	Calcium dobesilate (Doxium)	Group B included 50 Patients fulfilling the inclusion and exclusion criteria, was given Calcium Dobesilate for bleeding of endometrial origin

Primary Outcome Measures

Name	Time	Method
Reduction in blood loss	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

Trial Locations

Locations (1)

Sahiwal teaching Hospital Sahiwal; 🇵🇰 Sahiwal, Punjab, Pakistan