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

University of Health Sciences Lahore

Status: Not yet enrolling

Conditions: Abnormal Uterine Bleeding; Menorrhagia

Treatments: Drug: Calcium dobesilate (Doxium); Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06763094

Exp127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group A: Patients receiving Calcium Dobesilate (Doxium)

Active Comparator group

Description:

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.

Treatment:

Drug: Calcium dobesilate (Doxium)

Group B: Patients receiving Tranexamic Acid

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic Acid