Role of vitamin E and omega 3 fatty acid in management of dysmenorrhea
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Effect on average pain and maximum pain on VAS scale during menstruation in dysmenorrhea patients in 3 groups
研究概览
简要总结
We want to compare the effect of vitamin E and Omega 3 fatty acid on average and maximum pain during menstruation in dysmenorrhea patients. Participants will be enrolled after inclusion and exclusion criteria. Preintervention average pain and maximum pain during menstruation on VAS scale, average menstrual blood flow on PBAC chart and average number of NSAID tablets taken by patient for pain control during menstruation in the preceding last 3 menstrual cycle will be noted.. Participants will be randomized into 3 groups. Group A will receive 400 IU of vitamin E, group B will receive 600 mg of omega 3 fatty acid and group C will receive both 400 IU of vitamin E and 600 mg of omega 3 fatty acid orally starting from 5 days before the start of menstruation for a total of 8 days for 3 consecutive menstrual cycles. Postintervention following outcome will be assessed after 1st, 2nd and 3rd month - average and maximum pain during menstruation on VAS scale, menstruation blood flow on PBAC scale and total number of NSAID tablets taken by patient for pain during menstruation. Any side effects will be noted. appropriate statistical tests will be applied to compare the effects in 3 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females aged 18 to 45 years coming to Obstetrics and Gynaecology department with the diagnosis of dysmenorrhea.
排除标准
- •Patients with irregular menstrual cycles Patients requiring immediate surgical management Patients requiring immediate hormonal management Patients with active PID Patients with coagulopathy Patients taking opioid analgesic Patients on anticoagulants Patients with liver disease Patients with cardiac disease.
结局指标
主要结局
Effect on average pain and maximum pain on VAS scale during menstruation in dysmenorrhea patients in 3 groups
时间窗: 1 month, 2 months, 3 months
次要结局
- Total number of NSAID tablets taken during menstruation in dysmenorrhea patients(1 month, 2 months, 3 months)
- Effect on menstrual blood flow ( PBAC) in three groups(1 month, 2 months, 3 months)
研究者
Kanchan Rani
Teerthanker Mahaveer Medical College and Research Centre, Moradabad