Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 1:54 AM
Study NCT ID:
NCT06763094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-08
First Post:
2024-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Calcium Dobesilate Versus Tranexamic Acid for Treating Heavy Menstrual Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008595', 'term': 'Menorrhagia'}, {'id': 'D008796', 'term': 'Metrorrhagia'}], 'ancestors': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-01', 'studyFirstSubmitDate': '2024-12-21', 'studyFirstSubmitQcDate': '2025-01-01', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Menstrual Blood Loss', 'timeFrame': 'At the end of the third treatment cycle (each cycle is 28 days).', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Improvement in Hemoglobin Levels', 'timeFrame': 'At the end of the third treatment cycle (each cycle is 28 days).', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menorrhagia', 'Abnormal Uterine Bleeding']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nParticipants meeting the inclusion criteria will be randomly assigned to one of two groups:\n\nGroup 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.\n\nGroup 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.\n\nPrimary outcomes will include:\n\nReduction in menstrual blood loss as measured by the Pictorial Blood Loss Assessment Chart (PBAC).\n\nImprovement 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.\n\nData 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/dl\n2. Patient with pelvic pathologies like uterine fibroids, suspected adenomyosis, malignancies of uterus/cervix/ovary/vagina/endometrial hyperplasia with atypia.\n3. Patient with medical diseases like liver dysfunction, heart disease, migraine, stroke, renal disease, hypo/hyperthyroidism, 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'}, 'identificationModule': {'nctId': 'NCT06763094', 'briefTitle': 'Efficacy of Calcium Dobesilate Versus Tranexamic Acid for Treating Heavy Menstrual Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'University of Health Sciences Lahore'}, 'officialTitle': 'Efficacy of Calcium Dobesilate As an Alternative Method for Treatment of Menorrhagia, Comparison to Tranexamic Acid', 'orgStudyIdInfo': {'id': 'Exp127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A: Patients receiving Calcium Dobesilate (Doxium)', 'description': '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/day), starting from the first day of the menstrual cycle and continuing until the bleeding ceases.', 'interventionNames': ['Drug: Calcium dobesilate (Doxium)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: Patients receiving Tranexamic Acid', '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.', 'interventionNames': ['Drug: Tranexamic Acid']}], 'interventions': [{'name': 'Calcium dobesilate (Doxium)', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Group A: Patients receiving Calcium Dobesilate (Doxium)']}, {'name': 'Tranexamic Acid', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Group B: Patients receiving Tranexamic Acid']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bazgha Naeem, MS (OBSTETRICS & GYNAECOLOGY)', 'role': 'CONTACT', 'email': 'bazghatauqeer3@gmail.com', 'phone': '+923333522484'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Health Sciences Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post Graduate Resident', 'investigatorFullName': 'Bazgha Naeem', 'investigatorAffiliation': 'University of Health Sciences Lahore'}}}}