Effect of Tranexamic Acid and Calcium Dobesilate for Bleeding of Endometrial Origin (TXA)

November 26, 2024 updated by: Mahpara Shaukat, District Headquarters Teaching Hospital Sahiwal

Comparison of Efficacy 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Sahiwal, Punjab, Pakistan, 57000
        • Sahiwal teaching Hospital Sahiwal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Group A included 50 Patients fulfilling the inclusion and exclusion criteria, was given Tranexamic acid for bleeding of endometrial origin
Drug: Tranexamic Acid
Group A received Trannexamic Acid 500mg three times a day for 5 days
Experimental: Group B
Group B included 50 Patients fulfilling the inclusion and exclusion criteria, was given Calcium Dobesilate for bleeding of endometrial origin
Drug: Calcium dobesilate (Doxium)
Group B recieved Cap.Calcium Dobesilate 500mg 3 times a day for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

District Headquarters Teaching Hospital Sahiwal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

October 27, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Estimated)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2096 (PVAMC IRB)
  • DHQTHS (Other Identifier: DHQTHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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