Diabetic gastroparesis. Unspecified diabetes mellitus with unspecified complications ?
Conditions
Interventions
Intervention 1: In the intervention group, patients are provided with appropriate dietary advice. In addition, Pistacia Atlantica in the form of 2 gram Chewing gum is given to the patients, twice a da
Treatment - Drugs
Placebo
In the intervention group, patients are provided with appropriate dietary advice. In addition, Pistacia Atlantica in the form of 2 gram Chewing gum is given to the patients, twice a day, after meals,
Control group: in this group, the diet suitable for diabetic gastroparesis and Placebo will be given to the patients.
Sponsors
Vice chancellor for research of Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nausea 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Low-density lipoprotein. Timepoint: Baseline, the end of the study. Method of measurement: Blood test.;High-density ?lipoprotein. Timepoint: Baseline, the end of the study. Method of measurement: Blood test.;Aspartate aminotransferase. Timepoint: Baseline, the end of the study. Method of measurement: Blood test.;Alanine aminotransferaseh. Timepoint: Baseline, the end of the study. Method of measurement: Blood test.;Blood urea nitrogen. Timepoint: Baseline, the end of the study. Method of measurement: Blood test.;Glycated hemoglobin. Timepoint: Baseline, the end of the study. Method of measurement: Blood test.;Triglycerides. Timepoint: Baseline, the end of the study. Method of measurement: Blood test.;Cholesterol. Timepoint: Baseline, the end of the study. Method of measurement: Blood test.;?Complete blood count. Timepoint: Baseline, the end of the study. Method of measurement: Blood test.;Fasting blood sugar. Timepoint: Baseline, the end of the study. Method of measurement: Blood test.;Creatinine. Timepoint: Baseline, the end of the study. Method of measurement: Blood test. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh mahjoub
School of complementary and Persian medicineof Mashhad University of Medical Sciences
Outcome results
None listed