The effect of treatment regimen containing natural Iranian honey on the eradication of Helicobacter pylori infection
Design
Clinical trial with parallel control group, non-blind, randomized, phase 3 on 200 patients. A sealed envelope was used for randomization.
Settings and conduct
In this study, all patients referred to the gastrointestinal clinic of Shahid Beheshti Hospital in Kashan according to the endoscopy and biopsy results, peptic ulcer or gastritis as well as Helicobacter pylori infection were included in the study. Four weeks after the end of treatment, eradication of the infection will be checked by a stool antigen test for Helicobacter Pylori. Also from patients about the rate of adherence to the treatment regimen will be questioned.
Participants/Inclusion and exclusion criteria
Inclusion criteria: refer to the gastrointestinal clinic of Shahid Beheshti Hospital in Kashan; endoscopic and biopsy-confirmed peptic ulcer or gastritis; infection with Helicobacter Pylori confirmed by biopsy and fecal antigen test.
Exclusion criteria: previous history of treatment for Helicobacter Pylori; history for diabetes mellitus; existence of gastrointestinal anomalies.
Intervention groups
After controlling the entry and exit criteria of patients by selecting sealed envelopes, the study population are divided into case and control groups. Both groups are under treatment with the standard four-drug regimen of omeprazole, clarithromycin, bismuth and amoxicillin for two weeks. The case group in addition to receiving the standard drug regimen will receive every 8 hours 21 grams of natural honey Iran, produced by Mehram Company.
Main outcome variables
Helicobacter pylori infection eradication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151106024901N4
Registration date:2021-03-24, 1400/01/04
Registration timing:retrospective
Last update:2021-03-24, 1400/01/04
Update count:0
Registration date
2021-03-24, 1400/01/04
Registrant information
Name
Seyyed Mehdi Rasoolimanesh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
m_rasulimanesh@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-08, 1399/11/20
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect of Iranian natural honey on H. pylori infection
Public title
Evaluation of therapeutic effect of Iranian natural honey on H. pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Refer to the gastrointestinal clinic of Shahid Beheshti Hospital in Kashan
Endoscopic and biopsy-confirmed peptic ulcer or gastritis
Infection with Helicobacter Pylori infection confirmed by biopsy and fecal antigen test
Exclusion criteria:
Reluctance to participate in the project
Previous history of treatment for Helicobacter pylori
Having diabetes mellitus
Existence of gastrointestinal anomalies
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method and description of each method: simple randomization; randomization unit: individual; randomization tool: sealed envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Hekmat 56, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Approval date
2011-11-30, 1390/09/09
Ethics committee reference number
IR.TBZMED.REC.1399.786
Health conditions studied
1
Description of health condition studied
Gastric or duodenal ulcers
ICD-10 code
K25
ICD-10 code description
Gastric ulcer
Primary outcomes
1
Description
Helicobacter pylori eradication
Timepoint
Before treatment, 4 weeks after the end of treatment
Method of measurement
Stool antigen test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: omeprazole capsules 20 mg daily, clarithromycin 500 mg tablets every 12 hours, bismuth tablets 2 tablets daily and amoxicillin capsules 1 gram every 12 hours and Iranian natural honey made by Mehram company for 2 weeks daily 2 tablespoons
Category
Treatment - Drugs
2
Description
Intervention group: omeprazole capsules 20 mg daily, clarithromycin 500 mg tablets every 12 hours, bismuth tablets 2 tablets daily and amoxicillin capsules 1 g every 12 hours