A randomised double arm parallel clinical study to compare the effectiveness of Urtica Urens mother tincture versus Individualised homoeopathic medicine in the management of Gout
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
- Gout Impact Scale
研究概览
简要总结
The study will be a Prospective, Double Arm Parallel group, open label,
Randomized clinical study. Patients will be randomly allocated in 1:1 ratio by using
computerised Block Randomization into 2 groups: URTICA URENS MOTHER TINCTURE
treatment group and INDIVIDUALISED HOMOEOPATHIC MEDICINE treatment group.
Primary objective is to evaluate which is more effective i.e., URTICA URENS MOTHER TINCTURE or
INDIVIDUALISED HOMOEOPATHIC MEDICINE in management of Gout and; to assess the improvement of patient in terms of frequency of attack and severity of symptoms of Gout.
Duration of study is 1 year. Sample size is 60; 30 in each group.
Research Analysis
Assessment of clinical response/ outcome.
Relief from symptoms and suffering.
Assessment of improvement by using Gout Impact Scale and Pain Visual Analogue
Scale.
Laboratory investigations: Serum Uric Acid
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having sign and symptoms of Gout.
- •Pre diagnosed cases of Gout.
- •Patients who have not taken any treatment for gout in the last 2 weeks.
- •Patients with serum uric acid level over 7.0 mg/dl
- •Patients giving informed consent.
- •Patients willing to come for regular followups.
排除标准
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled systemic illness or life- threatening infections affecting quality of life or any vital organ failure.
- •Pregnancy, puerperium and lactation.
- •Substance abuse and/or dependence.
- •Self-reported immune-compromised state.
- •Patients who are already enrolled in some other study.
- •Patients who are not willing to give the consent.
结局指标
主要结局
Gout Impact Scale
时间窗: 1 month
次要结局
- Pain Visual Analogue Scale(1 month)
- Serum Uric Acid Level(4 weeks)
研究者
Dr Nandini Maurya
Nehru Homoeopathic Medical College and Hospital