Role of individualized homoeopathic medicine in modulating gut microbiota dysbiosis in patient with Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in gastrointestinal and dysbiosis symptoms, assessed using the Self-Dysbiosis Severity Score (SDSS) and laboratory parameters (Urine Indican Test or/and Stool Culture through MacConkey Agar Media and MRS Agar Media).
研究概览
简要总结
This research proposal focuses on investigating the role of individualized homoeopathic medicine in modulating gut microbiota dysbiosis in patients with Type 2 Diabetes Mellitus (T2DM). Background: T2DM is a chronic metabolic disease characterized by hyperglycemia that affects millions of people worldwide. Gut microbiota dysbiosis is associated with the development of T2DM. Justification: Conventional T2DM treatments often overlook underlying microbial imbalances. This study explored the potential of homoeopathy in addressing both glycemic control and gut microbiota dysbiosis. Research question: This study aimed to determine whether individualized homoeopathic medicine can significantly modulate gut microbiota dysbiosis in T2DM patients. Objectives: To evaluate the effect of individualized homoeopathic medicine on gut microbiota dysbiosis in T2DM patients using Dys-R) and Self Dysbiosis Severity Score (SDSS) as primary objectives and changes in glycemic parameters and other related outcomes as secondary outcomes. Methodology: The study will likely involve clinical assessments and laboratory tests to measure changes in the gut microbiota and diabetes-related parameters. The study will follow up with the enrolled cases monthly or as needed. Outcome: The primary assessment will use the Self-Dysbiosis Severity Score (SDSS) at baseline, 3 months, and 6 months, along with fasting blood sugar monitoring. Statistical analyses will be used to compare the data from these time points. Changes in gastrointestinal and dysbiosis symptoms using the SDSS and Laboratory parameters, such as the Urine Indican Test and, or Stool Culture (MacConkey Agar Media and MRS Agar Media), are the primary outcome measures. Measurements were taken at baseline, 3 months, and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Diagnosed Case of Type 2 Diabetes Mellitus (blood glucose level fasting more than 126mg per dl to less than 200 mg per dl Postprandial Blood glucose more than 200 mg per dl to less than 300 mg per dl HbA1C more than 6.5 percent to 8 percent) 2 Presence of gastrointestinal and dysbiosis symptoms suggestive of gut dysbiosis based on Dys R and Self Dysbiosis Severity Score (SDSS) In Dys R Scale maximum score is 14 (Score more than 8 Risk of dysbiosis and score less than or equal to 8 No risk of dysbiosis) Self-Dysbiosis Symptom Severity score Based on important symptoms of dysbiosis.
- •Total number of questions is
- •Each question symptom may get value from 0 to 3 according to their intensity.
- •Maximum number of total scores will be 45 and symptom severity classified as 1 to 15 Mild Dysbiosis 16 to 30 Moderate Dysbiosis 31 to 45 Severe Dysbiosis.
- •Total score exceeding 30 will be considered for study.
- •3 Urine Indican test positive and or stool culture through MacConkey Agar Media and MRS Agar Media showing evidence of dysbiosis.
- •4 Participants willing to give consent for participating in the study.
- •5 Participants who can understand Bengali or Hindi or English language.
排除标准
- •1 Recent use (within 3 month) of antibiotics probiotics or prebiotics that could alter gut microbiota.
- •2 History of inflammatory bowel disease (IBD) irritable bowel syndrome (IBS) or chronic liver disease.
- •(based on previous medical diagnosis or by red flag signs for example rectal bleeding weight loss fever).
- •3 Ongoing treatment with corticosteroids and immunosuppressants.
- •4 Alcohol or other substance abuse.
- •5 Pregnant and lactating mothers.
结局指标
主要结局
Changes in gastrointestinal and dysbiosis symptoms, assessed using the Self-Dysbiosis Severity Score (SDSS) and laboratory parameters (Urine Indican Test or/and Stool Culture through MacConkey Agar Media and MRS Agar Media).
时间窗: Baseline, 3rd month and 6th months.
次要结局
- Changes in fasting blood glucose level in individual with T2DM while observing changes in dysbiosis during homoeopathic treatment.(Baseline, 3rd month and 6th months.)
研究者
Dr Shantanu Satpathy
National Institute Of Homoeopathy