The Comparison of the effect of Psyllium seed on the resolution and recurrence of Gastroesophageal Reflux Disease (GERD) with oral omeprazole in patients with functional constipation: A Randomized Clinical Trial study
The patients with three years history of refractory gastroesophageal reflux disease (GERD) and functional constipation will undergo upper endoscopy. The patients (132 individuals) with esophagitis based on the Los Angeles classification will be participated in the study. According to random numbers table, the patients will be divided into two groups. One group will recieve omeprazole capsules (67 patients) and the other psyllium powder (65 patients). The two groups will be compared in terms of relieving GERD symptoms including burning sensation in the epigastrium and regurgitation and also the disease recurrences. The omeprazole group will receive twenty milligram omeperazole capsules half an hour before breakfast and dinner for two months. The population who will be treated with psyllium powder will be given five gram of the bulking agent solved in warm water, one hour before breakfast and dinner for two months, with a goal of bowel movements and a complete sense of defecation. All patients will be visited weekly for two months and questioned about the symptoms of GERD. Those who experience complete resolution of symptoms at the end of second month will be followed every week, for another 3 months, to evaluate the symptoms recurrences, given scores based on visual scales. Patients will be regarded as complete responders if they receive the score of zero, partial responders (scores 1-4) and Non-responders (≥ scores 5) who will be excluded from the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040315122N2
Registration date:2015-10-26, 1394/08/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-26, 1394/08/04
Registrant information
Name
Masoumeh Salari
Name of organization / entity
Mashhad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2742
Email address
salarim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2015-02-28, 1393/12/09
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the effect of Psyllium seed on the resolution and recurrence of Gastroesophageal Reflux Disease (GERD) with oral omeprazole in patients with functional constipation: A Randomized Clinical Trial study
Public title
Effect of Psyllium seed on the gastric reflux in patients with constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Symptomatic patients with minimum three years history of gastroesophageal reflux disease and functional constipation whose esophagitis in upper endoscopy will be confirmed.
Exclusion criteria: History of or current gastrointestinal cancer; Hiatal hernia; Irritable bowel syndrome; Endocrine diseases (e.g., hypothyroidism); Drug-induced constipation; Psychological disorders; Cardiovascular diseases; Liver diseases; Renal diseases; Opiums abuse
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The assessor and the statistical analyst were unaware of the two groups.
According to random numbers table, the patients will be divided into two groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashad University Of Medical Sciences
Street address
Goreyshi Building, Doktora Square, Daneshgah Street, Mashhad
City
Mashhad
Postal code
Approval date
2015-02-28, 1393/12/09
Ethics committee reference number
930965
Health conditions studied
1
Description of health condition studied
Gastro-esophageal reflux disease
ICD-10 code
K21.0
ICD-10 code description
Gastro-esophageal reflux disease with esophagitis
Primary outcomes
1
Description
Assessment reflux disease remission with constipation improvement
Timepoint
First day, 7th day, 14th day, 21th day, 28th day, 35th day,42th day, 49th day and 56th day after intervention.
Method of measurement
History of heart burn and regurgitation(clinical symptoms of GERD) was taken. Then the visual scale was used for evaluation.
Secondary outcomes
empty
Intervention groups
1
Description
Psyllium: The population treated with psyllium will be given 5 mg of the bulking agent solved in hot tap water one hour before breakfast and dinner with a goal of bowel movements and a complete sense of defecation twice daily.
Category
Treatment - Drugs
2
Description
Omeprazole: The omeprazole group will receive twenty-milligram omeprazole capsules half an hour before breakfast and dinner.