CTRI/2024/07/070417尚未招募Phase 3 4
An exploratory single arm study on the efficacy of siddharthak agada vati and purana ghrita nasya in the management of Kaphaja unmada (depressive disorders)
Post Graduate Institute of Ayurved Jodhpur1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月12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
- 30
- 试验地点
- 1
- 主要终点
- Changes in BDI Score
研究概览
简要总结
This study is single arm, an open label trial, with single group of 30 patients to assess the efficacy of Siddharthak agada vati and Purana Ghrita Nasya in the management of Kaphaja Unmada. The primary objective of the study is reducing subjective criteria BDI score. drug will be administered with milk after meal in the dosage of 500mg vati orally thrice a day and 2 drops Nasal twice a day before meal. Total duration of the treatment is 45 days followed up once in a week regularly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed as per the criteria for mild and moderate depression as per ICD
- •Subject who had mild and moderate major depressive disorder and must had minimum total score of 14 and maximum of 28 on the 21 items of BDI (Beck Depression Inventory) score at baseline visit.
- •Patients between the age group of 18 Years–45Years.
- •Patients of either gender, irrespective of socioeconomic.
- •Subject willing to follow the procedures as per the study protocol and voluntarily signed and informed consent form.
排除标准
- •Patients with other psychiatric disorders like schizophrenia, bipolar mood disorders and substance abuse.
- •Patients with severe depressive disorders.
- •Suicidal ideation Patients with other systemic disorders like uncontrolled hypertension, diabetes mellitus, tuberculosis.
- •Pregnant and lactating mothers or planning to become pregnant during the study.
- •Clinically unfit for therapy.
结局指标
主要结局
Changes in BDI Score
时间窗: 45 days
次要结局
- To improve the Quality of Life(45 days)
研究者
Dr Kiran Kamaliya
Post Graduate Institute Of Ayurved Jodhpur Rajasthan
研究点 (1)
Loading locations...
相似试验
尚未招募
Unknown
Vitamin C in improving skin brightness and enhancing overall skin parametersCTRI/2025/09/095336UAS Pharmaceuticals Pty Ltd32
尚未招募
不适用
A study to evaluate the efficacy and safety of the test product on the tanned skin.CTRI/2025/09/095413Zydus Wellness Products Limited36
尚未招募
Unknown
Check efficacy of Niacinamide Serum for skin pigmentation and glossCTRI/2025/09/095314UAS Pharmaceuticals Pty Ltd32
尚未招募
2 期
A Prospective, Single-Arm, Exploratory Study of IBI363 in ES-SCLC Patients After Immunotherapy ProgressionNCT07289048Union Hospital, Tongji Medical College, Huazhong University of Science and Technology35
尚未招募
不适用
A Study to Assess the Safety and Effectiveness of Bizfer XT Tablet (Iron, Zinc, Folic Acid, and Vitamin B12) in Improving Hemoglobin Levels in Patients with Iron Deficiency AnemiaCTRI/2025/07/090055J. B. chemicals & pharmaceuticals LTD.110