CTRI/2024/08/073131尚未招募Phase 3 4
Evaluation of Comparative Efficacy of Gorakhmundi vati versus Hingwadi vati with adjuvant therapy of Marma Chikitsa in the management of Vishada( mild depression)- Rodomized Controlled Trial.
Mahatma Gandhi Ayurved College Salod Wardha1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月16日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Will be assessed using Hamilton Depression Rating Scale. [HDRS-17]
研究概览
简要总结
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, salod(H), Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trail is a parallel group, randomized, open clinical, standard controlled trial, it will include a 30 days treatment period.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients which are willing to prticipate in the study and to give written informed consent.
- •Patients are selected irrespective of gender, race and religion.
- •Patients between 18-50 years of age group.
- •Patients having mild symptoms of depression i.e.having HDRS score between 8-16
- •Patients with history of depression less than one year.
- •Patients who were under meidication for depression previously but not using now.
排除标准
- •Patients having any other systemic disease.
- •A lifetime history of psychotic disorder.
- •Patients under the age of 18 years and above the age of 50 years.
- •Patients with moderate to severe depression i.e.having HDRS score between 17-52
- •Pregnant women.
- •Lactating women.
- •Bipolar disorder.
- •Obsessive compulsive disorder.
结局指标
主要结局
Will be assessed using Hamilton Depression Rating Scale. [HDRS-17]
时间窗: 30 days
次要结局
- The out come will be assessed using Hamilton Depression Rating Scale. [HDRS -17](30 days)
研究者
Dr Hemangi Patil
Mahatma Gandhi Ayurved College, Salod, Wardha.
研究点 (1)
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