[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574731":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":25,"responsibleParty":36,"collaborators":25,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":25,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":25,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":25,"overallStatus":60,"whyStopped":25,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":25},{"fullName":5,"class":6},"University of Health Sciences Lahore","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: Patients receiving Calcium Dobesilate (Doxium)","ACTIVE_COMPARATOR","Intervention: Patients in Group A will be administered Calcium Dobesilate (Doxium) capsules.\n\nDosage: 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\u002Fday), starting from the first day of the menstrual cycle and continuing until the bleeding ceases.",[13],"Drug: Calcium dobesilate (Doxium)",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B: Patients receiving 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.",[18],"Drug: Tranexamic Acid",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Calcium dobesilate (Doxium)","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.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Tranexamic Acid","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.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Bazgha Naeem, MS (OBSTETRICS & GYNAECOLOGY)","CONTACT","+923333522484","bazghatauqeer3@gmail.com",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Bazgha Naeem","Post Graduate Resident","100574731","efficacy-of-calcium-dobesilate-versus-tranexamic-acid-for-treating-heavy-menstrual-bleeding-100574731",false,"NCT06763094","Efficacy of Calcium Dobesilate Versus Tranexamic Acid for Treating Heavy Menstrual Bleeding","Efficacy of Calcium Dobesilate As an Alternative Method for Treatment of Menorrhagia, Comparison to Tranexamic Acid","Inclusion Criteria:\n\n1. Patients age 18 to 39 years\n2. Patients with menorrhagia\n3. Incidence of breakthrough bleeding while on treatment\n4. Patient with heaviness of the bleeding\n\nExclusion Criteria:\n\n1. Patients with hemoglobin less than 7gm\u002Fdl\n2. Patient with pelvic pathologies like uterine fibroids, suspected adenomyosis, malignancies of uterus\u002Fcervix\u002Fovary\u002Fvagina\u002Fendometrial hyperplasia with atypia.\n3. Patient with medical diseases like liver dysfunction, heart disease, migraine, stroke, renal disease, hypo\u002Fhyperthyroidism, platelet disorders or coagulopathy.\n4. 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","FEMALE","18 Years","39 Years",{"count":51,"type":52},100,"ESTIMATED","INTERVENTIONAL",[55],"NA","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:\n\nDoes 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.\n\nParticipants will:\n\nTake calcium dobesilate or tranexamic acid during their menstrual cycle for three consecutive cycles.\n\nRecord menstrual blood loss using the Pictorial Blood Loss Assessment Chart (PBAC).\n\nAttend follow-up visits after each menstrual cycle to monitor hemoglobin levels, menstrual symptoms, and any side effects.",[58,59],"Menorrhagia","Abnormal Uterine Bleeding","NOT_YET_RECRUITING","2025-01-01",{"date":63,"type":64},"2025-01-08","ACTUAL",{"date":66,"type":52},"2025-01-05",{"date":68,"type":52},"2025-12",{"name":5,"class":6}]