An open labelled double arm non randomized phase II clinical trial to evaluate the efficacy of siddhar yoga maruthuva muraigal and siddha medicine AVURI ILAI KUDINEER in the management of AZHAL KEEL VAYU
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The outcome of the study will be assessed by using the Universal Pain assessment scale
研究概览
简要总结
The study isAN OPEN LABELED DOUBLE ARM NON RANDOMIZED PHASE II CLINICAL TRIAL, TO EVALUATE THE EFFICACY OF SIDDHAR YOGA MARUTHUVA MURAIGAL AND SIDDHA MEDICINE "AVURI ILAI KUDINEER[INTERNAL]†IN THE MANAGEMENT OF AZHAL KEEL VAYU â€. The trial drug will be administrated at the dose of 30ml/ twice a day A/F 48 days in 40 patients. The trial period of 12 months will be carrying out
in Government Siddha Medical College & Hospital, Palayamkottai, Tirunelveli, Tamil Nadu. ThePrimary Outcome:
The study aims at bringing light on the Efficacy of the long standing traditional practice of Siddhar yogam therapy towards the management of Azhal keel vayu.
It is expected that Siddhar yogam therapy along with AVURI illai kudineer will produce expected results in managing the problem of Azhal keel vayu.
Secondary Outcome:
The positive impact of Yoga in the treatment aspect may be highlighted through this study . In case of any adverse event (AE) is noticed and it will be referred to
pharmacovigilance department of SCRI. Further management of patient will be given in OPD
facility.
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
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient having the symptoms of joint pain in one or both knee joints swelling tenderness stiffness crepitation restricted movement of joints Patients who are willing to give radiological investigation and provide blood for lab investigation Patients who are willing to participate in this study with the knowledge of potential risks and who are willing to sign the informed consent form.
排除标准
- •â€¢ Rheumatoid arthritis •cardiac disease history of trauma carcinoma Tuberculosis Patients with any other serious illness Pregnancy women and lactating mothers.
结局指标
主要结局
The outcome of the study will be assessed by using the Universal Pain assessment scale
时间窗: 48 days
(before and after treatment)
时间窗: 48 days
次要结局
- •The positive impact of Yoga in the treatment aspect may be highlighted through this study.(48days)