The effect of Pistacia atlantica gum on diabetic gastroparesis

Phase 2

• Conditions: Diabetic gastroparesis.; Unspecified diabetes mellitus with unspecified complications ?; E14.8 ?

• Registration Number: IRCT2016110630739N1
• Lead Sponsor: Vice chancellor for research of Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Type 1 or 2 diabetic patients older than 18 years with clinical symptoms of ?gastroparesis for more than 3 months that determined by GCSI questionnaire. ?
Exclusion criteria: organic disorders in the upper endoscopy in patients with risk factors such as unexplained weight loss, ?odynophagia, dysphagia, gastrointestinal cancer, family history for gastrointestinal cancer and age over 55 years? evidence of mechanical obstruction of the stomach or bowel? History of gastrectomy, ?gastric bypass, gastroplasty, pyloroplasty and vagotomy? Patients with heart failure, kidney failure, ?hepatitis or liver failure? Uncontrolled thyroid disorders? Endoscopic botulinum toxin injection in ?the pylorus in the past 6 months? Patients who have been treated with electrical stimulation of the stomach? ?Consumers of medicines that induce delayed gastric emptying such as Acarbose, Miglitol, Exenatid, ?benzodiazepines, calcium channel blockers, narcotics, alpha-2 adrenergic receptor agonists such as ?clonidine, tricyclic antidepressants, dopamine agonists, cholinergic muscarinic receptor antagonists, ?Octreotide, phenothiazines, cyclosporine? Patients with dry mouth and dry tongue? History of allergy to Pistacia atlantica? ?Pregnancy and lactation? Patient's unwillingness to continue the project; incidence of possible side effects

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ausea and vomiting. Timepoint: At baseline and after 1,2,3,4 and 8 weeks. Method of measurement: GCSI questionnaire.;Postprandial fullness/early satiety. Timepoint: At baseline and after 1,2,3,4 and 8 weeks. Method of measurement: GCSI questionnaire.;Bloating. Timepoint: At baseline and after 1,2,3,4 and 8 weeks. Method of measurement: GCSI questionnaire.;Upper abdominal pain. Timepoint: At baseline and after 1,2,3,4 and 8 weeks. Method of measurement: GCSI questionnaire.;Lower abdominal pain. Timepoint: At baseline and after 1,2,3,4 and 8 weeks. Method of measurement: GCSI questionnaire.;Heartburn/regurgitation. Timepoint: At baseline and after 1,2,3,4 and 8 weeks. Method of measurement: GCSI questionnaire.