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临床试验/CTRI/2025/07/091670
CTRI/2025/07/091670尚未招募不适用

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

Vinoth C1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月11日最近更新:

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

发起方
Vinoth C
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Vinoth C

AIIMS, Rishikesh

研究点 (1)

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