In vitro antioxidant activity of Nux vomica 6C and open label randomised clinical trial to evaluate the effectiveness of Nux vomica 6C in comparison with individualised homoeopathic medicines in functional dyspepsia: an integrative study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- evaluate the antioxidant activity of nux vomica 6c by using antioxidant assays and the response of the patients will be observed by changes in the DSSI score before and after intervention in assessed
研究概览
简要总结
This research proposal aims to investigate the antioxidant properties of Nux vomica 6c and its clinical effectiveness in treating functional dyspepsia. Nux vomica is a common treatment for functional dyspepsia, particularly for symptoms related to a sedentary lifestyle. Although its therapeutic effectiveness has been established, the scientific understanding of its mechanism of action is limited. Few clinical studies have assessed the efficacy of Nux vomica in functional dyspepsia. Recent pharmacological research suggests that oxidative stress may play a significant role in dyspepsia, and antioxidant remedies may offer therapeutic benefits. However, the antioxidant properties of different Nux vomica potencies have not been thoroughly evaluated in vitro. There is a lack of integrative studies correlating the biochemical actions of Nux vomica with its clinical effects, limiting its validity in evidence-based frameworks. This knowledge gap highlights the need to compare preclinical (in vitro) results with clinical efficacy to validate the use of Nux vomica in functional dyspepsia from both scientific and homoeopathic perspectives. The study has two main components: in vitro assessment of Nux vomica 6c’s antioxidant potential using antioxidant assays and clinical comparison of Nux vomica 6c with individualized homoeopathic medicine in treating functional dyspepsia. A preclinical study followed by an open-label randomized clinical trial will be conducted. The sample size will be 128 patients (64 per group). The primary outcomes will be antioxidant activity of Nux vomica 6c b) Changes in Dyspepsia Symptom Severity Index (DSSI) scores. The secondary outcome will be quality of life changes measured by Short-Form Nepean Dyspepsia Index (SF-NDI). This study aimed to bridge the gap between the traditional use and scientific validity of Nux vomica in treating functional dyspepsia, addressing the lack of integrative studies correlating its biochemical actions with its clinical effects.
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
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Age between 18 to 60 years Both sexes and all religions 2 Individuals who provide written informed consent 3 Females who are not pregnant or breastfeeding during the course of the study 4 Patients not currently taking any other treatment allopathic or homeopathic for dyspepsia 5 Patients who are otherwise clinically stable and fit to participate in the study 6 Individuals willing to adhere to follow-up visits and treatment protocol 7 Patients who are eligible to read Bengali English Hindi 8 Patients diagnosed clinically by DSSI score above 15.
排除标准
- •1 Age below 18 and above 60 2 Pregnancy and Malignancy 3 Known case of cardiac and liver diseases 4 Patients on going treatment with corticosteroids immune suppressants 5 Patients suffering from any severe psychiatric illness 6 Patients not willing to give written consent 7 Patients diagnosed clinically by DSSI score below 15.
结局指标
主要结局
evaluate the antioxidant activity of nux vomica 6c by using antioxidant assays and the response of the patients will be observed by changes in the DSSI score before and after intervention in assessed
时间窗: Baseline and 3 months
次要结局
- : evaluate pre and post intervention changes of the quality of life of the patients by using SF-NDI(baseline and 6 months)
研究者
Dr Mudalige Don Kusal Pradeep Gunawardana
National Institute of Homoeopathy
