An interventional Study To Assess The Effectiveness Of Guajacum Officinale In The Cases Of Arthralgia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the effectiveness of GUAJACUM OFFICINALE through evaluation of Pre and post NRS scores in the cases of Arthralgia
研究概览
简要总结
This study is prospective, open-label, interventional, single-arm, and unicentric to assess the effectiveness of GUAJACUM OFFICINALE in the cases of Arthralgia. This study will evaluate the extent of improvement in joint pain using NRS Scale as an Assessment scale. The primary outcome will be according to the scores obtained (pre- and post-treatment) from the NRS score. The secondary outcome is to ascertain clinically proven symptoms of GUAJACUM OFFICINLALE, if any.
NULL HYPOTHESIS(H0)- there is no significant improvement assessed through pre and post-NRS scores in the cases of Arthralgia by Prescribing GUAJACUM OFFICINALE
ALTERNATE HYPOTHESIS(H1)- there is significant improvement assessed through pre and post-NRS scores in the cases of Arthralgia by Prescribing GUAJACUM OFFICINALE
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
- 20.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •patient with signs and symptoms suggestive of arthralgia based on clinical history and examination As per Signs and Symptoms Patients with 3-4 Confirmatory signs and Symptoms given below shall be enrolled for the study (joint pain or tenderness redness warmth or swelling reduced mobility stiffness tingling or other unusual sensation numbness burning feeling itching) patient taking other modes of treatment and ready to stop their treatment patient giving consent for study.
排除标准
- •Cases require emergency or surgical treatment pregnant and lactating women will not be included immuno compromised patients such as those suffering from HIV Hepatitis B C etc cases with Multi Systemic illness and advanced pathology.
结局指标
主要结局
To assess the effectiveness of GUAJACUM OFFICINALE through evaluation of Pre and post NRS scores in the cases of Arthralgia
时间窗: Pre-scores will be taken at the baseline of treatment, and post score will be assessed at the end of 12 weeks using NRS scale
次要结局
- to ascertain clinically proven symptoms of GUAJACUM OFFICINALE if any(12 months)
研究者
Dr Sachin Kumar Yadav
Dr MPK Homoeopathic Medical College Hospital and Research Centre