To assess the effect of Pistacia Lentiscus extract in Patients with Diabetic Gastroparesis
Phase 2
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2024/03/063741
- Lead Sponsor
- Dr Rashi Mittal and Dr Ravi Kant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Type 2 diabetes patients more than 18 years of age and diagnosed as Diabetic gastroparesis with increased small bowel transit time
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 drugTimepoint: At baseline, 2 weeks, 4 weeks, 6 weeks and 8 weeks
- Secondary Outcome Measures
Name Time Method To calculate GCSI score pre and post intervention in both groupsTimepoint: Baseline at 0 weeks then at completion of 8 weeks;To find out the change in small intestinal transit time by using pistacia lentiscus plant extractTimepoint: AT completion of 8 weeks;To find out the effect of mastic gum on Hba1C, blood sugars, lipid profileTimepoint: Baseline data compared to data at 8 weeks;To Find the proportion of patients having Diabetic Gastroparesis by using GSCI score and Gastric Emptying ScintigraphyTimepoint: at the time of screening