Comparison of "Dosin" with triple therapy in eradication of helicobacter pylori infection in patients with helicobacter pylori infection and functional dyspepsia: A Randomized Controlled Clinical Trial.
Mixture of "Dosin" is a combination of Nigella sativa seeds and honey that has been advised in Islamic medicine to subside abdominal pain, bloating, nausea and anorexia. The main objective of this study is to compare the effect of “Dosin” with triple therapy in eradication of helicobacter pylori infection. At first, a pilot study on 10 patients with H. pylori infection and functional dyspepsia will be conducted. Diagnosis of infection is based on Urea Breath Test (UBT). Diagnosis of functional dyspepsia is based on one or more of the following symptoms in the absence of organic diseases: a burning sensation or discomfort in the upper abdomen or lower chest, sometimes relieved by food or antacids, early satiation and bothersome postprandial fullness. They will take mixture of “Dosin” 1 teaspoon/tds for 14 days by mouth. UBT will be repeated 4 weeks after the end of intervention. If “Dosin”can eradicate H. pylori in more than 60 % of cases, the next phase of study will be conducted. At this stage, ninety patients with H. pylori infection and dyspepsia will be allocated in 3 groups randomly. Patients in the first group will take mixture of “Dosin” 1 teaspoon/tds for14 days by mouth. Patients in the second group will take Amoxicillin 1 g/bd, clarithromycin 500 mg/bd and pantoprazole 20 mg/bd for 14 days by mouth. Patients in the third group will take mixture of “Dosin” 1 teaspoon/tds , pantoprazole(20 mg/bd) for 14 days by mouth. The second UBT will be repeated four weeks after the end of interventions. Three groups will be compared for H. pylori eradication rate and symptoms of dyspepsia
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209041957N3
Registration date:2012-09-24, 1391/07/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-09-24, 1391/07/03
Registrant information
Name
Fataneh Hashem Dabaghian
Name of organization / entity
Research Institute for Islamic and Complementary Medicine
Country
Iran (Islamic Republic of)
Phone
+98 21 3395 0152
Email address
fatanehdabaghian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Research Institute for Islamic and Complementary Medicine, Tehran University of Medical Sciences
Expected recruitment start date
2012-10-01, 1391/07/10
Expected recruitment end date
2013-12-01, 1392/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of "Dosin" with triple therapy in eradication of helicobacter pylori infection in patients with helicobacter pylori infection and functional dyspepsia: A Randomized Controlled Clinical Trial.
Public title
Effects of "Dosin" in Helicobacter pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 20-60 years old, documented helicobacter pylori infection and functional dyspepsia.
Exclusion criteria: pregnancy, breast feeding, duodenal or gastric ulcer, cancer or bleeding, usage of NSAIDs, corticosteroids, bismuth, antibiotics, proton pomp inhibitors and anticoagulants 4 weeks before the study.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be conducted by the table of random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Research Institute for Islamic and Complementary Medicine
Helicobacter pylori [H.pylori] as the cause of diseases classified
Primary outcomes
1
Description
Helicobacter pylori infection
Timepoint
Six weeks after beginning of intervention
Method of measurement
Urea Breath Test
Secondary outcomes
1
Description
Dyspepsia
Timepoint
Six weeks after beginning of intervention
Method of measurement
Dyspepsia questionnaire
Intervention groups
1
Description
Intervention: Mixture of
Category
Treatment - Drugs
2
Description
Control group 1: Mixture of
Category
Treatment - Drugs
3
Description
Control group 2: Amoxicillin capsule 1 g/bd, Clarithromycin capsule 500 mg/ bd and Pantoprazole tablet 20 mg/bd by mouth for 14 days. Amoxicillin of Farabi company and clarithromycin and pantoprazole of Tehran shimi company will be bought from Red Crescent pharmacy of Tehran.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoole Akram Hospital
Full name of responsible person
Mansureh Tavusi
Street address
Niayesh St., Sattarkhan Ave., Tehran, IRAN
City
Tehran
2
Recruitment center
Name of recruitment center
Added at 2012-12-31: Shahid Taleghani Hospital
Full name of responsible person
Added at 2012-12-31: Ramin Tavafzadeh, Babak Gholamin
Street address
Added at 2012-12-31: Shahid Taleghani Hospital,Shahid Beheshti Blv., Kermanshah, IRAN
City
Added at 2012-12-31: Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute for Islamic and Complementary Medicine, Tehran Unive