A Phase 2/3 interventional study of Tranexamic Acid and Calcium dobesilate (Doxium) in Heavy. Mentrual Bleeding, Abormal utèrine Bleeding and Bleeding, sponsored by District Headquarters Teaching Hospital Sahiwal. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by District Headquarters Teaching Hospital Sahiwal · Phase 2/3, Interventional, and Treatment
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.
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.
3,011 studies on the registry are indexed under Hemorrhage; 466 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 1,990 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →District Headquarters Teaching Hospital Sahiwal is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Group A included 50 Patients fulfilling the inclusion and exclusion criteria, was given Tranexamic acid for bleeding of endometrial origin
Drug: Tranexamic Acid
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 A received Trannexamic Acid 500mg three times a day for 5 days
Group B recieved Cap.Calcium Dobesilate 500mg 3 times a day for 5 days
Reduction in blood loss
Blood loss at baseline and three months after treatment will measured. Reduction in blood loss will be calculated after three months of treatment
Time frame: Three months
Plan to share: No — Patient privacy
Ran from Jan 2022 to primary completion in Dec 2023, 23 months.
Of 24 phase 2/3 interventional studies under Hemorrhage, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 62. This study's 23 months is below that.
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Tranexamic Acid · Calcium Dobesilate
District Headquarters Teaching Hospital Sahiwal