CTRI/2021/01/030625尚未招募不适用
An open label single arm clinical study on effectiveness ofsiddharthaka agada arka pratimarsha nasya in kaphajaunmada (depressive disorders)
SDM college of ayurveda and hospital hassan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in the score of Hamilton depression scale, by the use of Siddharthaka agada arka pratimarsha nasya in the management of Kaphaja unmada (depressive disorders).
研究概览
简要总结
This study is an open-labeled single-arm prospective clinical study to assess the effectiveness of Siddharthaka agada arka pratimarsha nasya, 2 drops to each nostril twice daily, before food in the age group 18 to 60 years, for 30 days in 30 patients of Kaphaja unmada (mild or moderate major depressive disorder) and will be conducted in one center in India. The secondary outcome will be the Hamilton depression scale after 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed as per the criteria for mild and moderate depression as per ICD
- •Age between 18 to 60 years.
- •Patients of either gender, irrespective of socioeconomic status.
- •Patients ready to sign an informed consent form.
排除标准
- •Patients with other psychiatric disorders like Schizophrenia, Bipolar mood disorder, and substance abuse.
- •Patients with severe depressive disorder.
- •Pregnant women.
- •Patients with other systemic disorders like uncontrolled Hypertension, Diabetes mellitus, Tuberculosis.
结局指标
主要结局
Improvement in the score of Hamilton depression scale, by the use of Siddharthaka agada arka pratimarsha nasya in the management of Kaphaja unmada (depressive disorders).
时间窗: outcomes will be assessed at baseline, 15 days and 30 days.
次要结局
- Hamilton Depression scale(15 days, 30 days)
研究者
研究点 (1)
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