Open clinical trial to evaluate the efficacy of WHS/2004/1 in Dysmenorrhoea & Menstrual Irregularities.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Relief from symptoms of Dysmenorrhea
研究概览
简要总结
In the present study, the effect of a polyherbal preparation, Dabur Mensta, was studied on 50 women in the mean age group of 15-45 years suffering from dysmenorrhoea in an open label , prospective clinical study. The drug was administered through oral route at a dose of I0 ml b.i.d. for 12 weeks . On day 0 the subjects were evaluated and recruited in to the study after due consideration of the inclusion and exclusion criteria. Complete systemic examination is conducted and investigations are performed as desired.The treatment was continued for 12 weeks and thus covering minimum two cycles after the initiation of treatment. The treatment is stopped after 12 weeks and there were two follow-ups, every two weeks without treatment to observe the withdrawal after cessation of the trial drug treatment. After enrollment, all the subjects were given placebo syrup till the date of occurrence of the next cycle. Then treatment was started from 15th day of menstrual cycle. All the subjects were evaluated thereafter fortnightly (at 2 weekly intervals). In total 7 visits were planned for the period of 120 days. Difference in the mean VAS scores from baseline to end is analyzed to find out the efficacy of the trial drug. The treatment was continued for three cycles.
Results
The trial drug provided significant relief from all the five symptoms of dysmenorrhea. Pain abdomen and pain lower back are the two symptoms with maximum severity; Maximum relief on VAS score was achieved on Pain in abdomen 33.20 (41.50) & 29.00 (54.98%) respectively . Reduction of VAS scores in the other three symptom categories was also significant (P<0.05) . The drug also provided relief from incapacitation due to menstrual pain in all the
trial subjects. Majority of subjects reported with moderate to severe incapacitation at baseline viz ., 94 %. After the administration of the trial drug, this was reduced to 48% showing a reduction by 46%. These findings indicate the comprehensive effect of the trial drug on the symptoms of dysmenorrhea concluding the analgesic effect of the trial drug. The effect of the trial drug is cumulative and gradual in reducing effect on menstrual pain and incapacitation .
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 15.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients aged between 15-45 years (females in the reproductive age group).
- •Females presenting with DYSMENORRHEA with or without any of the following symptoms associated with menstruation a.
- •Any kind of pain like headache, backache abdominal pain,bodyache b.
- •Nausea and vomiting c.
- •Weakness d.
- •Psychological symptoms- like anxiety, stress, depression, irritability, restlessness e.
- •Irregular cycles
- •Willingness to participate in the trial and to come for regular follow up as and when required.
- •Readiness to sign Informed Consent Form.
排除标准
- •Patients nursing or pregnant women.
- •Patients having organic causes of pain and menstrual abnormalities like uterine myeloma, adenomyosis, polyps, fibroids, endometriosis etc.
- •Patients suffering from systemic or metabolic disorders like pituitary disease, diabetes mellitus, thyroid dysfunction and coagulation-disorders.
- •Patients having any other kind of chronic disease like respiratory or cardiac problems, HIV.
- •Subjects not willing to sign informed consent.
- •Patients participating in any other clinical study.
结局指标
主要结局
Relief from symptoms of Dysmenorrhea
时间窗: Evaluations were done at 2 week intervals for 12 weeks
次要结局
未报告次要终点