Investigating the effect of oral administration of Pistacia Atlantica Kurdica gum on the eradication of H.pylori in patients with dyspepsia symptoms: a randomized clinical trial
Objective
Evaluating performance of Pistacia Atlantica Kurdica Gum on the eradication of H. pylori infection and improving dyspepsi symptoms.
Design
180 patients were referred to the Gastroenterology center that 111 people were UBT positive. 11 patients were excluded due to lack of follow up. A sample of 100 people is divided in 4 groups of 25. Blinding was the consistency of the drug in 500 mg capsules. There have been randomized by the random number table. This study is a one center and single phase.
Setting
Patients divided into 4 groups. Group A: three drugs including 500 mg of Amoxicillin bd, Clarithromycin 500 mg bd and Omeprazole 20 mg bd for 14 days. Group B: Group A drugs plus the capsule containing 1g of powdered PAKG bd for 14 days. Group C: the capsule inclosing 1g of powdered PAKG bd for 14 days. Group D: this group took placebo-enclosing capsule bd for 14 days. Dyspeptic symptoms before and after healing period and the UBT results two days before the start of treatment and 30 days after the completion were compared in 4 groups.
Participants
Inclusion criteria
UBT positive;symptoms of indigestion; avoiding use of antibiotics
Conditions exclusion
Pregnancy and lactation; having ulcers or stomach cancer; appearing side effects; the patient withdrawal study
Intervention
The use of tree gum turpentine for groups and a placebo for control group.
Pulmonary function changes as the primary outcome variable and secondary outcomes include headache - abdominal pain - diarrhea - nausea
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042527599N1
Registration date:2016-05-25, 1395/03/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-25, 1395/03/05
Registrant information
Name
Hamidullah Afrasiabian
Name of organization / entity
Traditional Medicine, Research Center for Traditional Persian Medicine, Shiraz University of Medical
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 7589
Email address
afrasiabian@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Shiraz University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of oral administration of Pistacia Atlantica Kurdica gum on the eradication of H.pylori in patients with dyspepsia symptoms: a randomized clinical trial
Public title
The effect of natural turpentine Kurdica on Helicobacter pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
Gastrointestinal clinic patients 20 to 40 years old; UBT positive symptoms of indigestion; avoiding the use of antibiotics
Exclusion criteria
Pregnancy and lactation; the development of pharmaceutical agents stopped the study; travel or unwillingness to continue treatment; lack of medication; taking the wrong medication
Age
From 20 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Street headquarters Shiraz University of Medical Sciences
City
Shiraz
Postal code
71345-1978
Approval date
2015-06-21, 1394/03/31
Ethics committee reference number
IR.SUMS.REC.1394.48
Health conditions studied
1
Description of health condition studied
H. pylori infection of the stomach
ICD-10 code
B99
ICD-10 code description
Other and unspecified infectious diseases
Primary outcomes
1
Description
Pulmonary function changes
Timepoint
2 days before and 30 days after the intervention
Method of measurement
According to the DOB
Secondary outcomes
1
Description
Headache - abdominal pain - diarrhea - nausea
Timepoint
During the intervention
Method of measurement
Qualitative
Intervention groups
1
Description
Control group: Two placebo capsules, 500 mg (bd) for 14 days
Category
Placebo
2
Description
Intervention group 1: 500 mg of Amoxicillin bd, Clarithromycin 500 mg bd and Omeprazole 20 mg bd, obtained from Pharmaceutical Sobhan for 14 days
Category
Treatment - Drugs
3
Description
Intervention group 2: intervention group 1 drugs plus two capsules containing 500mg of powdered Pistacia Atlantica kurdica bd for 14 days.
Category
Treatment - Drugs
4
Description
Intervention group 3: two capsules containing two 500mg of powdered Pistacia Atlantica kurdica obtained from Department of Pharmacology, Shiraz University of Medical Sciences bd for 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid Motahhari professional clinic of Namazi hospital of Shiraz University of Medical Sciences
Full name of responsible person
Hamidollah Afrasiabian
Street address
Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basire Hashemi
Street address
Shiraz University of Medical Sciences
City
Shiraz
Grant name
--
Grant code / Reference number
--
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Scien
Full name of responsible person
Hamidollah Afrasiabian,MD
Position
Ph.D. candidate
Other areas of specialty/work
Street address
Zand st Shiraz University of Medical Sciences
City
Shiraz
Postal code
71356-44144
Phone
+98 21 2273 0456
Fax
Email
afrasiabian@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Scien
Full name of responsible person
Mohammad Hadi Imanieh,MD
Position
Specialty in Gastroenterology
Other areas of specialty/work
Street address
Central Organization of Shiraz University of Medical Sciences
City
Shiraz
Postal code
71356-44144
Phone
+98 712112325
Fax
Email
imanieh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Gastroenterology, Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Mohammad Ali Nejati,MD
Position
Speciality in gastroenterology
Other areas of specialty/work
Street address
Zand st, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
71356-44144
Phone
+98 71 3233 7589
Fax
Email
Nejati@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)