CTRI/2024/07/070196尚未招募Phase 3 4
A clinical efficacy of sameergaj kesari ras, medhya rasayan along with cognitive behavioral therapy in the management of ahiphen vyasana (opium addiction)
Post Graduate Institute of ayurved, jodhpur, rajasthan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月15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
- Reduction in the COWS score of the patient
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 sameergaj kesari ras (2 tablet B.D.) along with medhya rasayan ( 3 gm B.D. ) with CBT in the management of opium addiction. The primary objective of the study is reducing subjective criteria COWS score. drug will be administered with lukewarm water after meal in the dosage of 2 tablet BD and 3gm BD orally twice a day. Total duration of the treatment is 42 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
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed Patient moderate sever withdrawal symptoms with COWS score of 24-
- •Age between
- •60year. Clinical manifestation of opium withdrawal patient including agitation, anxiety, muscles aches, increased tearing, insomnia, runny nose, sweating, yawning and late symptoms include: abdominal cramping, nausea, vomiting, diarrhea, dilated pupils, goose bumps etc which will be presented at that time. Patient willing to give consent for clinical trial. Patients of either sex.
排除标准
- •Opium addicted patients who are suffering from major psychiatric disorder.
- •Opium addicted previously diagnosed patients of major systemic illness like myocardial infarction, Ischemic heart disease, Hypertension, Tuberculosis, Bronchial Asthma, HIV- AIDS, Cancer, Major respiratory disease, liver failure, Renal failure and Renal toxicity etc.
结局指标
主要结局
Reduction in the COWS score of the patient
时间窗: 42 days
次要结局
- To improve the Quality of Life(42 days)
研究者
Dr Naresh lohiya
Post Graduate Institute Of Ayurved Jodhpur
研究点 (1)
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