Comparison of Ormeloxifene versus Tranexamic acid in the management of abnormal uterine bleeding in reproductive age group women - a randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To compare the PBAC score of patients after treatment with Ormeloxifene and Tranexamic Acid
研究概览
简要总结
Aim of the study is to assess the utility of Tab .Ormeloxifene over Tab .Tranexamic acid in the control of menorrhagia with fewer side effects. Objectives of the study is to compare the efficacy, to compare the mean Pictorial blood loss assessment chart scores, effect of hemoglobin levels in the two groups , to compare adverse effects, to assess the need for change of therapy between Ormeloxifene versus Tranexamic acid.This study is a randomized control trial conducted in the department of obstetrics and Gynecology at IGMC&RI among reproductive age group women who present to OPD with menorrhagia . A detailed history will be elicited with regard to demography, complaints, past obstetrics history, medical and surgical history, detailed menstrual history ,clinical examination , necessary investigations and PBAC scoring will be done to assess the menstrual blood loss. PBAC score more than 100 denotes menorrhagia. Participants meeting inclusion criteria and willing to participate in the study , after getting consent subjects will be randomized into either of two groups. Group A will be given Tab .Ormeloxifene 60mg twice a week for 3 months followed by once a week for 3 months . Group B will be given Tab. Tranexamic acid 500mg TDS during periods .Patients will be advised to report immediately if they do not respond to therapy. Follow up will be done at 3rd and 6th month. At each visit PBAC score, Hb, ET will be measured to assess the efficacy of the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 44.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged 25-44 years with complaints of menorrhagia and willing to participate in the study.
排除标准
- •1.Pregnancy 2,Women who have delivered within the last 1 year 3.Women who have had abortions in the past 3 months 4.Any drug allergy 5.Post menopausal women 6.Fibroid 7.Adenomyosis 8.Endometriosis 9.Cervical dysplasia 10.Endometrial hyperplasia with atypia 11.Thyroid disorders 12.Breast and genital malignancies 13.Hepatic and renal dysfunction 14.Patient already on antifibrinolytic therapy 15.Patient already on any hormonal therapy.
结局指标
主要结局
To compare the PBAC score of patients after treatment with Ormeloxifene and Tranexamic Acid
时间窗: At the time of recruitment to study , 3rd and 6th month after starting treatment
次要结局
- 1.Effect on blood hemoglobin levels(2.Need for change of therapy while on the intervention)