An interventional study of Calcium dobesilate (Doxium) and Tranexamic Acid in Menorrhagia and Abnormal Uterine Bleeding, sponsored by University of Health Sciences Lahore. Not yet recruiting. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by University of Health Sciences Lahore · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to determine if calcium dobesilate is an effective alternative to tranexamic acid for treating menorrhagia in women aged 18 to 39 years. The main questions it aims to answer are:
Does calcium dobesilate reduce menstrual blood loss and improve hemoglobin levels as effectively as tranexamic acid? What side effects and acceptability differences exist between calcium dobesilate and tranexamic acid? Researchers will compare calcium dobesilate to tranexamic acid to see if calcium dobesilate is as effective in reducing heavy menstrual bleeding and improving patient outcomes.
Participants will:
Take calcium dobesilate or tranexamic acid during their menstrual cycle for three consecutive cycles.
Record menstrual blood loss using the Pictorial Blood Loss Assessment Chart (PBAC).
Attend follow-up visits after each menstrual cycle to monitor hemoglobin levels, menstrual symptoms, and any side effects.
This randomized controlled trial aims to compare the efficacy and safety of calcium dobesilate and tranexamic acid in treating menorrhagia in women aged 18 to 39 years. Menorrhagia, characterized by heavy menstrual bleeding exceeding 80 mL per cycle, significantly impacts quality of life and may lead to complications such as anemia.
Participants meeting the inclusion criteria will be randomly assigned to one of two groups:
Group A: Participants will receive calcium dobesilate (500 mg capsules), administered orally at a daily dose of 0.5-2 g during each menstrual cycle for three consecutive cycles.
Group B: Participants will receive tranexamic acid (500 mg capsules), administered orally at a dose of two capsules three times daily during each menstrual cycle for three consecutive cycles.
Primary outcomes will include:
Reduction in menstrual blood loss as measured by the Pictorial Blood Loss Assessment Chart (PBAC).
Improvement in hemoglobin levels after three cycles. Arrest of bleeding after discontinuation of the medications. Secondary outcomes will focus on the acceptability of treatment and side effects, such as nausea, headache, and gastrointestinal discomfort.
Data will be collected through patient records, physical examinations, and follow-up visits. Stratification and statistical analyses will be conducted using SPSS to evaluate differences in efficacy and safety between the two groups. The results will contribute to identifying a suitable treatment option for managing menorrhagia in clinical practice.
156 studies on the registry are indexed under Uterine Hemorrhage; 19 are open to participants now.
This study's planned enrollment of 100 is close to the median of 96 across 111 interventional studies indexed under Uterine Hemorrhage.
Browse Uterine Hemorrhage studies →University of Health Sciences Lahore is the lead sponsor of 77 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intervention: Patients in Group A will be administered Calcium Dobesilate (Doxium) capsules. Dosage: The dose will be 500 mg of Calcium Dobesilate, administered orally at a frequency of three times a day. The total daily dose can range from 1-4 tablets (equivalent to 0.5-2 g/day), starting from the first day of the menstrual cycle and continuing until the bleeding ceases.
Drug: Calcium dobesilate (Doxium)
Intervention: Patients in Group B will receive Tranexamic Acid capsules. Dosage: The dose will be 500 mg of Tranexamic Acid, administered orally at a frequency of three times a day. This will continue from the first day of the menstrual cycle until the bleeding stops.
Drug: Tranexamic Acid
This intervention is unique because Calcium Dobesilate is not a hormonal agent and does not carry the risks associated with hormonal therapies, such as potential impact on fertility or long-term endocrine effects. Additionally, it may be more suitable for patients who cannot tolerate hormonal treatments due to contraindications such as previous thrombotic events or risk factors for thrombosis.
Tranexamic Acid stands out due to its non-hormonal action in managing menorrhagia, providing an alternative for women who are contraindicated for hormonal treatments or prefer non-hormonal solutions. Unlike other hormonal treatments, Tranexamic Acid does not impact fertility or have significant endocrine effects.
Reduction in Menstrual Blood Loss
Menstrual blood loss will be measured using the Pictorial Blood Loss Assessment Chart (PBAC). Participants will record the number and type of sanitary products used (e.g., pads or tampons) and the degree of saturation, along with any clots passed. PBAC scores above 100 are indicative of heavy menstrual bleeding. A reduction in PBAC scores after the third treatment cycle (each cycle lasting 28 days) will be used to determine the effectiveness of the intervention.
Time frame: At the end of the third treatment cycle (each cycle is 28 days).
Improvement in Hemoglobin Levels
Hemoglobin levels will be measured through venous blood samples using standard laboratory methods. Baseline levels will be recorded prior to treatment, and follow-up levels will be assessed at the end of the third treatment cycle (each cycle lasting 28 days). An increase in hemoglobin levels will indicate improved iron status and reduced anemia severity.
Time frame: At the end of the third treatment cycle (each cycle is 28 days).
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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University of Health Sciences Lahore