CTRI/2022/03/041419尚未招募4 期
Efficacy of Pistacia Lenticus Plant (Rumi Mastagi) inComparison to Levosupiride in Patients with Diabetic Gastroparesis A Double BlindRandomized Control Trial Study
dr ravikant1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2022年4月15日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- 1 improvement or changes in gastric transit time in diabetic gastroparesis time point - 8 weeks
研究概览
简要总结
| This study is a randomised double blind parallel group trial to compare efficacy of pistacia lenticus plant (RUMI MASTAGI) 500mg PO BD and levosupiride 25 mg PO BD in patients with diabetic gastroparesis: a pilot study, that will be conducted in All India Institute Of Medical Sciences , Rishikesh . |
The expected primary outcome measures will be improvement or changes in gastric transit time (scintigraphy) and Gastroparesis cardinal symptom index (GCSI) after 8 weeks of administration of lenticus gum.
The expected secondary outcomes Improvemet in Hb1AC level ,improvement in lipid profile of patient , Improvement in general well being , Postprandial fullness/early satiety after 8 week of ayurvedic medicine.( Mastig gum)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •all diabetic patients who are between 19 to 65 years of age with not meting exclusion criteria.
排除标准
- •diabetic patients with following conditions will be excluded from study- 1)Patient with PUD.
- •Irritable bowel syndrome.
- •Any known organic gastrointestinal or systemic diseases.
- •Diabetes in pregnancy lactation.
- •History of breast diseases.
- •Abnormalities of the menstrual cycle.
- •Previous abdominal surgery.
- •Mental disorders.
- •The use of drugs interfering with gastrointestinal motility.
- •The above diseases shall be ruled out by appropriate clinical assessment and patient case sheet records.
结局指标
主要结局
1 improvement or changes in gastric transit time in diabetic gastroparesis time point - 8 weeks
时间窗: 8 weeks
2 improvement in Gastroparesis cardinal symptom index (GCSI) - time point- 8 weeks
时间窗: 8 weeks
次要结局
- Improvemnet in Hb1AC level(imrovement in lipid profile)
研究者
研究点 (1)
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