CTRI/2023/07/055516尚未招募2 期
Comparative Clinical Study To Evaluate The Efficacy Of Brahmi Churna Capsule And Jatamansi Churna Capsule In Pre-Menstrual Syndrome.
Parul Institute Of Ayurveda1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月8日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To subside Pre-Menstrual Symptoms
研究概览
简要总结
Premenstrual syndrome is recognized as a psycho-neuro-endocrine disorder of unknown aetiology PMS encompasses a wide variety of emotional and physical symptoms that occur from several days to week before the onset of menstrual flow Various hypotheses are postulated to explain the etiopathogenesis of PMS.
Brahmi churna is very effective in psycho-neuro-endocrinal symptoms which relieves that symptoms and improves quality life of female.
Patients will be assesed on the basis of
1 PMS self rating scale
2.PMS Observer rating scale
3.PMS Vas scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age between 18 yrs to 40 yrs of age irrespective of socio economic status and in good medical health
- •Female subjects having regular menstrual cycle with cycle length of 21-35 days.
- •Having a minimum PMTS score >10 and VAS score >1
- •Symptoms should appear at definite time in luteal phase of the cycle.
- •The subject should be symptomatic for a period of last 3 or more than 3 months.
- •Symptoms should not persist beyond the 5th day of menstrual cycle.
- •The subjects who are ready to follow the treatment protocol and sign the informed consent.
排除标准
- •Women aged below 18 and above 40 years
- •Subject suffering from other acute or chronic psychiatric illness.
- •Those with symptoms existing less than 3 menstrual cycles.
- •Subjects suffering from organic brain diseases.
- •Subjects under hormonal and psychiatric treatment.
- •Subjects with premenstrual dysphoric disorder.
结局指标
主要结局
To subside Pre-Menstrual Symptoms
时间窗: 30 days
次要结局
- Improvement in quality of life.(The outcomes will be measured after screening at Base Line BT after 1 month & at the end of 2 months AT Assessment of clinical parameters will also be done at the end of the 3rd month after 1 month of medicine free period)
研究者
研究点 (1)
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