To Study the Efficacy of Individualised Homoeopathic Medicines in Cases of Functional Dyspepsia :- A Single Blind, Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1 To See the Role of Individualized Homoeopathic Medicine in comparison with Placebo in Cases of Functional Dyspepsia
研究概览
简要总结
The Study is Single Blind , Randomized , Placebo Controlled Trial to Assess the Efficacy of Individualized Homoeopathic Medicine in Cases of Functional Dyspepsia. The Study will be Conducted in 80 participants which will be enrolled in Jawaharlal Nehru Homoeopathic Medical College Hospital, Vadodara, Gujarat, India. SF-LDQ Scale will be used for Assessment Purpose. The Study would be Conducted in Time Duration of 1 Year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
入选标准
- •a) Patients covering the diagnostic criteria for FUNCTIONAL DYSPEPSIA (ROME IV CRITERIA) b) Age – 20 to 45 years c) Gender – both male and female d) All socio- economic status e) Willing to give informed consent.
排除标准
- •a) Patients having Organic Gastrointestinal diseases.
- •b) Patient having IBS (irritable bowel syndrome).
- •c) Severe psychiatric disorders.
- •d) Patients with malignancies.
- •e) Pregnant and lactating females.
结局指标
主要结局
1 To See the Role of Individualized Homoeopathic Medicine in comparison with Placebo in Cases of Functional Dyspepsia
时间窗: 3 Months and Interim Analysis at 1.5 Months, if Necessary
2 To Assess the Severity & Outcome of Patients before & after treatment in cases of Functional Dyspepsia by using Short Form-Leeds Dyspepsia Questionnaire (SF-LDQ)
时间窗: 3 Months and Interim Analysis at 1.5 Months, if Necessary
3 To Emerge the Therapeutics of Functional Dyspepsia
时间窗: 3 Months and Interim Analysis at 1.5 Months, if Necessary
次要结局
- 1 To Check & Verify the most common age group affected by this condition(2 To Find out the most frequently used Medicines)