跳至主要内容
临床试验/CTRI/2017/07/009173
CTRI/2017/07/009173进行中(未招募)不适用

to compare the effects of acotiamide on symptom profile and gastric emptying time with domperidone in diabetic gastroparesis: a double blind randomised control trial’

DRUSHA DUTTA1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年7月31日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
to compare the effects of Tablet Acotiamide on Gastric emptying time in patients with diabetic gastroparesis

研究概览

简要总结

Treatment with either drug is going to improve blood sugar levels and quality of life in diabetic patients

Patients will be regularly followed up during their one month therapy with either drug. Appearance of any untoward side effect will be taken into serious consideration. Patients will have the liberty to withdraw from the trial at any time.

At the end of one month therapy with either drug, patients will have to undergo repeat evaluation of gastric emptying time, small bowel transit time, gastric antral volume, gall bladder ejection fraction by the same aforementioned methods for comparison of the effects of the drugs.

Previous literature has shown the efficacy of Domperidone in diabetic gastroparesis without any serious side effect.

On the other hand, randomized control trials involving Acotiamide have shown promising results in functional dyspepsia without any significant side effect. Adequate trials in diabetic gastroparesis are awaited.

Assessment  and treatment of diabetic patient for gastroparesis is going to improve there quality of life and blood glucose control, So gastroparesis  requires pharmaceutical interventions for improvement of symptom profile and quality of life

Drugs available for gastroparesis have limited efficacy  ,tachyphylaxis (decreasing response with continued use )  ,and high rate of side effect profile .So there is urgent need of some novel drug bypassing all these limitations . So, if results of Acotiamide are found to be significantly beneficial in our trial, then it can be subjected to further analysis and it may be favourable for the population at large.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •Age above 18 years and below 65 years.
  • •Documented history of diabetes mellitus (type 2) for a duration of minimum 5 years.
  • •HbA1c 7-9gm% •Clinical evidence of gatroparesis with symptoms of post prandial fullness, early satiety, abdominal bloating, nausea, retching, vomiting of undigested food.

排除标准

  • Inability to obtain informed consent Pregnant or lactating women Patient with thyroid dydsfunction,renal failure ,parkinsons disease ,scleroderma Drug or alcohol abuse UGIE showing any mechanical obstruction Patient on GLP 1 analogues and pramlintides.

结局指标

主要结局

to compare the effects of Tablet Acotiamide on Gastric emptying time in patients with diabetic gastroparesis

时间窗: 4week drug duration

次要结局

  • Gatric antral volume bu USG of gastric antrum and gall bladder ejection fraction will be calculated

研究者

发起方
DRUSHA DUTTA
申办方类型
Research institution and hospital

研究点 (1)

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