Evaluating the effects of standardized hydroalcoholic extract of marmotti (Salvia mirzayanii Rech. f. & Esfand) capsule as adjunctive treatment in patient with helicobacter pylori infection
Evaluating the effects of capsules containing standardized hydroalcoholic extract of marmotti (Salvia mirzayanii Rech. F. & Esfand) as adjunctive therapy in patients with Helicobacter pylori infection
Design
This study is a randomized, double-blind, controlled clinical trial with a parallel group design of 50 patients.
Settings and conduct
Patients are selected from Kerman Baysat Clinic. Participants and physicians are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with dyspepsia and gastrointestinal symptoms, and with Helicobacter pylori infection is diagnosed with stool antigen test.
Exclusion criteria: Previous treatment for Helicobacter pylori eradication; penicillin or bitter merov plant allergy and gastric cancer.
Intervention groups
The treatment group received two 500 mg capsules containing bitter extract twice daily and the control group received the same placebo in terms of shape, color, and packaging with the same dose of the treatment group.
Main outcome variables
Stool antigen test is performed at baseline and 4 weeks after treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110310006026N9
Registration date:2019-09-23, 1398/07/01
Registration timing:registered_while_recruiting
Last update:2019-09-23, 1398/07/01
Update count:0
Registration date
2019-09-23, 1398/07/01
Registrant information
Name
Fatemeh Dabaghzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5034
Email address
dabaghzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of standardized hydroalcoholic extract of marmotti (Salvia mirzayanii Rech. f. & Esfand) capsule as adjunctive treatment in patient with helicobacter pylori infection
Public title
Evaluating the effects of standardized hydroalcoholic extract of marmotti (Salvia mirzayanii Rech. f. & Esfand) capsule as adjunctive treatment in patient with helicobacter pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with dyspepsia and gastrointestinal symptoms with Helicobacter pylori infection who diagnosed with stool antigen test
Exclusion criteria:
Earlier treatment of Helicobacter pylori eradication
Allergic to penicillin or marmotti
Stomach cancer
Age
From 15 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible participants are allocated to one of the two study groups in a 1:1 ratio. Allocation is by block randomization with a block size of four. A person (not involved in the trial) generates allocation sequence
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and physician: marmotti and placebo capsules had the same shape, color and outer packaging.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Beginning of Jahad Blvd., Tahmasebad Fourways
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2019-08-25, 1398/06/03
Ethics committee reference number
IR.KMU.REC.1398.251
Health conditions studied
1
Description of health condition studied
Helicobacter pylori
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Stool antigen
Timepoint
The first and second weeks after the beginning of the study and 4 weeks after the end of the study
Method of measurement
Stool antigen test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The treatment group receive 2 capsules of 500 mg containing bitter mulberry extract twice daily for 14 days.
Category
Treatment - Drugs
2
Description
Control group: They receive two 500 mg capsules of placebo twice daily for 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Besaat Clinic
Full name of responsible person
Fatemeh Dabaghzadeh
Street address
Haft bagh high way
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5212
Email
fatemeh_dabaghzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhtyi
Street address
Beginning of Jahad Blvd., Tahmasebad Fourways
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Kerman University of Medical Sciences , Haft Bagh ave, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5034
Fax
+98 34 3132 5003
Email
fatemeh.dabaghzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Kerman University of Medical Sciences , Haft Bagh ave, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5034
Fax
+98 34 3132 5003
Email
fatemeh.dabaghzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Kerman University of Medical Sciences , Haft Bagh ave, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5034
Fax
+98 34 3132 5003
Email
fatemeh.dabaghzadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available