Efficacy of Pistacia Lentiscus plant extract in patients with diabetic gastroparesis –with increased small bowel transit time: A Randomized double blind control trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To determine the improvement in GCSI score in patients with increased Small bowel Transit Time with Pistacia lentiscus plant extracts(Chios mastic gum) in comparison with a Placebo drug
研究概览
简要总结
Diabetes is a group of metabolic diseases characterized by hyperglycemia due to insulin secretion or action defects. Gastrointestinal neuropathies in patients with diabetes represent vital aspects of the chronic course of the disease. This can be perceived as chronic delayed gastrointestinal emptying associated with nausea, vomiting, postprandial fullness, weight loss, anorexia, and abdominal pain without evidence of mechanical obstruction. Small Bowel Transit is often found to be abnormal in Diabetic patients and may lead to small intestinal bacterial overgrowth. Upto 80% patients with diabetic gastroparesis have abnormal small bowel motility. Traditional treatments for Diabetic Gastroparesis include dietary changes and medication, but severe cases may require surgery or gastric electrical stimulation (GES). Pistacia species extracts suggest alleviating gastrointestinal symptoms, yet no Indian studies support the evidence despite Pistacia plant species being present in the Great Himalayan regions. This study explores the therapeutic potential of Pistacia plants in treating Diabetic Gastroparesis, in a subset of patients with delayed small bowel transit, leveraging their natural antioxidants to enhance gut motility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Type 2 diabetes patients more than 18 years of age and diagnosed as Diabetic gastroparesis with increased small bowel transit time.
排除标准
- •Patients with age less than 18yrs Patients with any known or clinically suspected organic Gastrointestinal disorder Patients with history of gastric surgeries Patient with Irritable bowel syndrome Patients with delayed Gastric Emptying time.
- •Patient with using drugs interfering with gastrointestinal motility.
结局指标
主要结局
To determine the improvement in GCSI score in patients with increased Small bowel Transit Time with Pistacia lentiscus plant extracts(Chios mastic gum) in comparison with a Placebo drug
时间窗: At baseline, 2 weeks, 4 weeks, 6 weeks and 8 weeks
次要结局
- To calculate GCSI score pre and post intervention in both groups(Baseline at 0 weeks then at completion of 8 weeks)
- To Find the proportion of patients having Diabetic Gastroparesis by using GSCI score and Gastric Emptying Scintigraphy(at the time of screening)
- To find out the change in small intestinal transit time by using pistacia lentiscus plant extract(AT completion of 8 weeks)
- To find out the effect of mastic gum on Hba1C, blood sugars, lipid profile(Baseline data compared to data at 8 weeks)
研究者
RASHI MITTAL
AIIMS RISHIKESH