Efficacy of individualized homoeopathic medicines in 50-millesimal potency in adult patients suffering from Irritable Bowel Syndrome with its miasmatic analysis: A Double-blind, Randomised, Placebo-controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- IBS- Severity Scoring System(IBS-SSS)
研究概览
简要总结
Irritable Bowel Syndrome (IBS; ICD-11-DD91.08) is one of the most frequently encountered gastrointestinal disorders in clinical practice, presenting with abdominal pain, altered bowel habits, and absence of detectable organic pathology. The etiology of IBS is multifactorial, involving motility disorders, visceral hypersensitivity, brain-gut axis dysregulation, and psychosocial factors. Irritable Bowel Syndrome (IBS) is typically characterized by abdominal pain or discomfort, accompanied by altered bowel habits, which may include constipation, diarrhoea, or a combination of both. Patients with IBS often report additional symptoms such as bloating, abdominal distention, symptoms triggered by food intake, and changes in pain location and stool patterns over time. Since IBS is a symptom-based disorder, treatment goals focus on alleviating symptoms such as pain, bloating, cramping, and diarrhoea or constipation. It mainly affects young and female individuals, and it tends to overlap with other functional gastrointestinal diseases (FGIDs) and causing a huge burden on life and society’s economy. It is a chronic relapsing condition that affects up to 11% of the global population and 16.7–24.2% of the United States population. The prevalence of IBS in North Indian people is around 4%, which poses a considerable burden on rural adults. Overall reported prevalence in different parts of India varies from 4.2 to 14%.
Despite the numerous publications on various IBS treatment strategies in modern medicine, there is no universally accepted protocol. Hence, satisfaction with modern treatment is often an unmet need for patients. IBS does not impose life-threatening complications, but it significantly affects the patient’s quality of life, impairing daily functioning and contributing to high work absenteeism, and imposes an economic burden on the health care system. Homoeopathy, being a holistic system of medicine, always treats the patients individually by acting in the psychosomatic sphere, making it very effective in cases of IBS, where physical symptoms and mental symptoms go hand in hand. IBS is a psychosomatic illness that affects both the body and the mind. IBS is brought on by psychological issues such as emotional stress, rage, fear, etc., as well as unusual sensitivity to particular foods. Homoeopathy emphasizes a holistic approach and addresses a patient’s interaction with their mind and body. Currently, there is no agreement on the best form of treatment for IBS. The homoeopathic system of medicine is based on a holistic approach in which both mental and physical symptoms are considered in each individual case, so we are able to find out the efficacy of Homoeopathy in the management of Irritable Bowel Syndrome. Also, 50-millesimal potencies compared with centesimal dynamization have more beneficial effects, with just sufficient homoeopathic aggravation required for the cure of the patient. Literature review reveals that homoeopathic treatment is effective in cases of IBS, with some conclusions regarding the effectiveness and safety of homeopathy for the treatment of IBS can be drawn. Hence, through this study, we aimed to evaluate the role of individualised homoeopathic medicines in 50-millesimal potencies using the Irritable Bowel Syndrome-Symptom Severity Scale (IBS-SSS) and the Irritable Bowel Syndrome-Quality of Life (IBS-QOL) scores as the primary and secondary outcome measures, respectively, at baseline and every month up to 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients fulfilling Rome IV diagnostic criteria for IBS (recurrent abdominal pain that occurs an average of at least 1 day/week and is associated with two or more of the following three features: (1) related to defecation (relief or worsening), (2) associated with a change in frequency of stool, or (3) associated with a change in form (appearance) of stool)
- •Literate patients with the ability to read Bengali, Hindi, and/or English.
排除标准
- •Patients having clinical features like unexplained weight loss, bleeding PR, and persistent diarrhoea.
- •Patients having disease symptoms secondary to organic causes like celiac disease, Inflammatory bowel disease and lactose malabsorption, etc.
- •Any major gastrointestinal surgery in the last 6 months
- •Currently receiving standard therapy for IBS and/or homeopathic treatment for any chronic condition(s) especially in last 6 weeks
- •Diagnosed cases of unstable psychiatric complaints or other systemic diseases affecting the quality of life
- •Pregnant, lactating, and puerperal women
- •Self-reported immune-compromised conditions and
- •Substance abuse and/or dependence.
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
IBS- Severity Scoring System(IBS-SSS)
时间窗: At baseline, and every month, up to 3 months
次要结局
- IBS-Quality of Life(IBS-QOL)(At baseline, and every month, up to 3 months)
