Efficacy of Pistacia lentiscus plant extract (Mastic gum) in comparison to Prucalopride in Type 2 diabetic patients with constipation- A randomized open label controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the improvement in CTT (colon transit
研究概览
简要总结
Gastrointestinal manifestations in type 1 and 2 diabetes are common and represent substantial causes of morbidity and health care costs as well as diagnostic and therapeutic challenge. Prucalopride, a selective serotonin agonist has been proved to have effect in both colon transit time as well as gastric emptying time and is an approved drug for constipation and is used in diabetic gastrointestinal neuropathies. There are some tolerable side effects of this drug in chronic use. Because of this, there is a need to find a drug, which can help to improve gastroparesis symptoms with sustainable effects. Mastic gum is not only a natural product with minimum or no side effects but also easily acceptable for most geriatric as well as younger diabetic population. Currently patients are being screened. Eligible patients will be recruited after obtaining clearance.
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
- •• Type 2 Diabetes Mellitus with constipation satisfying Rome IV Criteria.
- •• Age 18-60 Years.
排除标准
- •Pregnancy and Lactating Mothers
- •Allergy to egg/ any component of meal taken before the nuclear scan
- •Known organic gastrointestinal disorder
- •History of gastrointestinal surgery
- •On drugs interfering gastrointestinal motility like prokinetics, domperidone, tricyclic antidepressants, thyroxine, anti-thyroid drugs.
结局指标
主要结局
To compare the improvement in CTT (colon transit
时间窗: At baseline | 4 weeks after intervention
time) and GSRS (Gastrointestinal Symptom Rating
时间窗: At baseline | 4 weeks after intervention
Scale) in diabetic patients with constipation among
时间窗: At baseline | 4 weeks after intervention
those receiving Pistacia lentiscus extracts (group1)
时间窗: At baseline | 4 weeks after intervention
and prucalopride (group2)
时间窗: At baseline | 4 weeks after intervention
次要结局
- 1. To monitor side effects & compliance with Pistacia lentiscus extract & Prucalopride(At baseline)
- 2. To compare the improvement in GSRS (Gastrointestinal Symptom Rating Scale) score & correlate it with improvement in colon transit time(At baseline)
研究者
Vinoth C
AIIMS, Rishikesh
