Efficacy of herbal drug that is composed of essential oil of Zataria multiflora Boiss, Trachyspermum ammi and Anethum graveolens L, in treatment of Irritable bowel syndrome (IBS).
This is a randomized, double-blind clinical trial with the aim to study the influence of a herbal drug that is composed of essential oil of Zataria multiflora Boiss, Trachyspermum ammi and Anethum graveolens L, in treatment of Functional dyspepsia. Study population is the patients that referred to gastroenterology clinic and sample size for study is 50 person. The inclusion criteria are written consent, complete knowledge about the study and being diagnosed with Irritable bowel syndrome based on the ROME III criteria. The exclusion criteria are the participants’ lack of consent to continue their participation in the study, warning symptoms and signs of gastric and intestinal cancers, other chronic gastrointestinal diseases and peptic ulcer disease, also, kidney or liver diseases based on patient history, physical examination and medical records. The study will last for 14 days, and the participants will be randomly divided into two groups; namely, the intervention group (receiving capsules containing the essential oil of the plant), and the control group (receiving hyoscine 20 mg tablet three times a day for 2 weeks). Moreover, patient characteristics such as severity of disease symptoms, and quality of life will enter into a form ( prepared in advance) at the beginning, at the end, and two weeks after completion of treatment in order to assess treatment outcome. After completion of the treatment, the safety of the treatment regimen will also be assessed by doing laboratory tests and through recording adverse drug reactions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072629026N3
Registration date:2016-12-29, 1395/10/09
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-12-29, 1395/10/09
Registrant information
Name
Ghasem Bordbar
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 3280
Email address
ghasem.bordbar@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences.Hormozgan Science & Technology Park.
Expected recruitment start date
2016-07-05, 1395/04/15
Expected recruitment end date
2017-01-14, 1395/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of herbal drug that is composed of essential oil of Zataria multiflora Boiss, Trachyspermum ammi and Anethum graveolens L, in treatment of Irritable bowel syndrome (IBS).
Public title
Herbal drug for treatment of Irritable bowel syndrome (IBS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written consent and complete knowledge about the study;
being diagnosed with Irritable bowel syndrome based on the ROME III criteria.
Exclusion criteria:
The participants’ lack of consent to continue their participation in the study;
warning symptoms of gastric and intestinal cancers, other chronic gastrointestinal diseases and peptic ulcer disease;
kidney and liver diseases based on patient history, physical examination, and medical records.
Age
From 17 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The randomization method in this study will be simple randomization and by using the random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellery for research of Hormozgan University of Medical Science.
Street address
Vice-chancellery for research, Shahid Mohamadi hospital, Bandar Abbas, Iran.
City
Bandar Abbas
Postal code
Approval date
2015-07-07, 1394/04/16
Ethics committee reference number
HUMS.REC.1394.012
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
Quality of life
Timepoint
Before intervention, end of intervention, 2 weeks after intervention
Method of measurement
(IBS-QOL)
2
Description
Relife of symptoms
Timepoint
end of intervention, 2 weeks after intervention
Method of measurement
IBS Adequate relief (IBS-AR)
3
Description
Relife of symptoms
Timepoint
end of intervention, 2 weeks after intervention
Method of measurement
IBS Global Assessment improvement(IBS-GAI)
4
Description
average score of Irritable bowel syndrom
Timepoint
Before intervention, end of intervention, 2 weeks after intervention
Method of measurement
(IBS-SSS)IBS Symptom Severity Scale
Secondary outcomes
1
Description
Amount of drug consumption
Timepoint
after intervention
Method of measurement
By checking the residual amount of drug after intervention
2
Description
Elevation of liver enzymes
Timepoint
after intervention
Method of measurement
labratory test(AST,ALT,ALP,Billi T,D)
3
Description
Dysfunction of kidney
Timepoint
after intervention
Method of measurement
labratory tests (BUN,Cr)
4
Description
Drug side effects
Timepoint
During and after intervention
Method of measurement
Entry the side effects by patient and Responsible for study in side effects form
Intervention groups
1
Description
Intervention group: Prescription of edible capsule containing 60mg of essential oil of Ajwain fruit,zataria multifora,dill oil , 4 times a day for 2 weeks.
Category
Treatment - Drugs
2
Description
Control group: Prescription of hyoscine 20 mg tablet three times a day for 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohamadi hospital
Full name of responsible person
Ghasem Bordbar
Street address
Shahid Mohamadi hospital, Bandar abbas, Hormozgan, Iran
City
Bandar abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan Science & Technology Park
Full name of responsible person
Majid Sarnay zade
Street address
Health Technology Incubation Center, Azadegan, Bandar Abbas, Iran.
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan Science & Technology Park
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Majid Sarnay zade
Street address
Vice Chancellor for research of Hormozgan University of Medical Sciences, Shahid Mohamadi hospital,Bandar Abbas, Iran
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan University of Medical Sciences
Proportion provided by this source
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
Hormozgan University of Medical Science
Full name of responsible person
Ghasem Bordbar
Position
Medical student
Other areas of specialty/work
Street address
Student research comitte, Vice-chancellery for research, Shahid Mohamadi hospital, Iran.