Efficacy of Calcium Dobesilate Versus Tranexamic Acid for Treating Heavy Menstrual Bleeding

Not Applicable

Not yet recruiting

• Conditions: Menorrhagia; Abnormal Uterine Bleeding
• Interventions: Drug: Calcium dobesilate (Doxium); Drug: Tranexamic Acid

• Registration Number: NCT06763094
• Lead Sponsor: University of Health Sciences Lahore

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-12-21
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-01
• Last Update Submitted: 2025-01-01
• Study Start: 2025-01-05
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-11-05
• Study Completion: 2025-12

Recruitment & Eligibility

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

Inclusion Criteria

1. Patients age 18 to 39 years
2. Patients with menorrhagia
3. Incidence of breakthrough bleeding while on treatment
4. Patient with heaviness of the bleeding

Exclusion Criteria

1. Patients with hemoglobin less than 7gm/dl
2. Patient with pelvic pathologies like uterine fibroids, suspected adenomyosis, malignancies of uterus/cervix/ovary/vagina/endometrial hyperplasia with atypia.
3. Patient with medical diseases like liver dysfunction, heart disease, migraine, stroke, renal disease, hypo/hyperthyroidism, platelet disorders or coagulopathy.
4. Patient with previous history of thrombosis; pregnancy, abortion, use of IUCDs or oral contraceptives; lactating women in first 6 months of post-natal period and hypersensitivity to the drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Patients receiving Calcium Dobesilate (Doxium)	Calcium dobesilate (Doxium)	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.
Group B: Patients receiving Tranexamic Acid	Tranexamic Acid	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.

Primary Outcome Measures

Name	Time	Method
Reduction in Menstrual Blood Loss	At the end of the third treatment cycle (each cycle is 28 days).	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.

Secondary Outcome Measures

Name	Time	Method
Improvement in Hemoglobin Levels	At the end of the third treatment cycle (each cycle is 28 days).	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.