Efficacy Of Individualized Homoeopathic Medicines In Treatment Of Lactose Intolerance - A Randomized Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Reduction in symptoms of lactose intolerance, such as abdominal pain, bloating, flatulence, nausea in patients receiving individualized homoeopathic treatment
研究概览
简要总结
Aim-
To evaluate the efficacy of individualized homoeopathic medicines in the treatment of lactose intolerance and their role in improving the quality of life of affected individuals.
Objectives-
To determine which homoeopathic medicine is most effective in treating lactose intolerance.
To monitor changes in Visual Analog Scale : Lactose-intolerance-related symptoms (VAS), Bristol stool scale after giving homoeopathic medicines.
**Introduction:**Lactose intolerance primarily refers to having different symptoms upon the consumption of foods containing lactose. It is one of the most common form of food intolerance and occurs when lactase activity is reduced in the brush border of the small bowel mucosa. Individuals may be lactose intolerant to varying degrees, depending on the severity of these symptoms. When lactose is not digested, it can be fermented by gut microbiota leading to symptoms of lactose intolerance that include abdominal pain, bloating, flatulence, and diarrhea with a considerable intra-individual and inter-individual variability in the severity of clinical manifestations. Homoeopathy is a vital philosophy in that it interprets diseases and sickness as caused by disturbance in a vital force or life force. Homoeopathic cure is mild, gentle, developed through growth, is dynamic in nature. This study aims to evaluate the efficacy of individualized homoeopathic medicines in managing lactose intolerance, adopting a holistic approach to address the manifestations of the condition.
**Study Design :**Randomized control trial – Single blind method Randomization method – coin flip method
Heads-Group- A (treatment group ) , Tails – Group- B (control group)
Study procedure: The study begins with a target sample size of 92 children diagnosed with lactose intolerance. Each participant undergoes detailed case taking, which includes medical history, general physical examination, and confirmation of lactose intolerance as per ICD-10 diagnostic criteria. Once eligibility is confirmed based on inclusion and exclusion criteria, the participants are randomized into two groups of 46 each: one receiving individualized homoeopathic treatment and the other receiving a placebo. Prior to the initiation of treatment, baseline scoring is conducted using the Visual Analogue Scale (VAS) for lactose intolerance symptoms, the Bristol Stool Scale, and the KIDSCREEN-10 index to assess quality of life. Following this, the individualized treatment or placebo is administered according to group allocation. Participants are then followed up at intervals of 15 days, and at 1, 2, and 3 months—though this may vary depending on the patient’s clinical condition. At the end of the study, a final evaluation is conducted, including repeat case taking, physical examination, and reassessment of lactose intolerance
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Clinically diagnosed patients with lactose intolerance 2 Age range- 5 to 12 years of age 3 Children of Both sexes 4 Willingness to participate- Patient’s parents willing to participate in the study and provide informed consent.
排除标准
- 未提供
结局指标
主要结局
Reduction in symptoms of lactose intolerance, such as abdominal pain, bloating, flatulence, nausea in patients receiving individualized homoeopathic treatment
时间窗: Before final exams of part 2
次要结局
未报告次要终点
研究者
BANMEET KAUR
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute
