CTRI/2024/07/070011尚未招募Phase 3 4
An exploratory single-arm study on kaktinduk vati and mansayadi choorna in the management of ahiphena vyasana (opium addiction)
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2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 kaktinduk vati and mansayadi choora 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 4gm and 2 tablets orally twice a day. Total duration of the treatment is 28 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 with mild to moderate withdrawal symptoms with COWS score of 5-12 & 13-24 Age between 16-60 years.
- •Clinical manifestations of Opium withdrawal patients include Restlessness, Anxiety, Muscle aches, Increased lacrimation, Insomnia, Runny nose, Sweating, and Yawning.
- •Late symptoms include Abdominal cramps, Nausea, Vomiting, diarrhoea, Dilated pupils, Gooseflesh Skin etc.
- •which will be presented at that time.
- •Patient willing to give consent for clinical trial.
- •Patient of either sex.
排除标准
- •Opium-addicted patients suffering from major systemic illnesses like Myocardial infarction, Ischemic heart disease, Hypertension, Tuberculosis, Bronchial asthma, HIV-AIDS, Cancer, Major respiratory disease, Liver failure, Renal failure, and Renal toxicity.
结局指标
主要结局
Reduction in the COWS score of the patient
时间窗: 28 Days
次要结局
- To improve the Quality of Life
研究者
Dr Mohit Saini
Post Graduate Institute Of Ayurved Jodhpur Rajasthan
研究点 (1)
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