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

NCT ID: NCT06707051

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Group A included 50 Patients fulfilling the inclusion and exclusion criteria, was given Tranexamic acid for bleeding of endometrial origin

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

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

Group B

Group B included 50 Patients fulfilling the inclusion and exclusion criteria, was given Calcium Dobesilate for bleeding of endometrial origin

Group Type EXPERIMENTAL

Calcium dobesilate (Doxium)

Intervention Type DRUG

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

Interventions

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Tranexamic Acid

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

Intervention Type DRUG

Calcium dobesilate (Doxium)

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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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District Headquarters Teaching Hospital Sahiwal

OTHER

Sponsor Role lead

Responsible Party

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Mahpara Shaukat

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sahiwal teaching Hospital Sahiwal

Sahiwal, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Alaqzam TS, Stanley AC, Simpson PM, Flood VH, Menon S. Treatment Modalities in Adolescents Who Present with Heavy Menstrual Bleeding. J Pediatr Adolesc Gynecol. 2018 Oct;31(5):451-458. doi: 10.1016/j.jpag.2018.02.130. Epub 2018 Mar 8.

Reference Type RESULT
PMID: 29524595 (View on PubMed)

Klebanoff JS, Marfori CQ, Ingraham CF, Wu CZ, Moawad GN. Applications of Tranexamic acid in benign gynecology. Curr Opin Obstet Gynecol. 2019 Aug;31(4):235-239. doi: 10.1097/GCO.0000000000000547.

Reference Type RESULT
PMID: 31022078 (View on PubMed)

Franz ND, Machado-Aranda D, Miller JT, Farina N. Impact of Obesity on Tranexamic Acid Efficacy in Adult Patients With Major Bleeding. Ann Pharmacother. 2021 Sep;55(9):1076-1083. doi: 10.1177/1060028020983323. Epub 2020 Dec 31.

Reference Type RESULT
PMID: 33384016 (View on PubMed)

Rahman S, Khan FS, Samin KA, Afridi N, Ahmed M. Efficacy of Oral Tranexamic Acid Versus Combined Oral Contraceptives for Heavy Menstrual Bleeding. Cureus. 2021 Oct 29;13(10):e19122. doi: 10.7759/cureus.19122. eCollection 2021 Oct.

Reference Type RESULT
PMID: 34858760 (View on PubMed)

Other Identifiers

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DHQTHS

Identifier Type: OTHER

Identifier Source: secondary_id

2096

Identifier Type: -

Identifier Source: org_study_id