To evaluate the efficacy of Z. multiflora essential oil (EO) against hepatic CE in comparison with albendazole.
Design
In this non randomized clinical study, 30 patients were divided into two groups and were treated with Z. multiflora essential oil and albendazole respectively. Since the patients were allowed to select their favorite drug (Albendazole or Z. multiflora essential oil), random distribution of the patients in two treatment groups was not feasible.
Settings and conduct
This non randomized clinical study was performed at Shiraz University of Medical Sciences (Shahid Faghihi Hospital) and Shiraz University, Shiraz, Iran.
Participants/Inclusion and exclusion criteria
1. Patients who accept the treatment protocol by signing the appropriate informed consent.
2. Patients aged 20 - 60 years old.
3. Patients with hepatic hydatid cysts smaller than 5 cm.
4. Patients with uncomplicated hydatid cysts (non calcified and non infected cysts).
5. Patients who were not simultaneously infected to pulmonary hydatid disease.
Intervention groups
30 patients , were divided into two groups (15 in each) and treated for 6 months (180 consecutive days) with Zataria multiflora essential oil (60 mg daily) and albendazole (800 mg daily) respectively. Z. multiflora essential oil soft capsules were produced by Barij Essence Pharmaceutical Company, Iran and albendazole tablets were produced by CIPLA LTD, India. Before the start of treatment and 2, 4 and 6 months after treatment, the size of the cysts were measured by sonography. Simultaneously, biochemical and hematological analysis were performed on the blood samples of patients. At the end of study, the mean size of the cysts and the results of the liver and kidney function tests were compared statistically between the patients of two treatment groups.
Main outcome variables
Reduction in the size of hydatid cysts.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180219038798N1
Registration date:2018-08-06, 1397/05/15
Registration timing:retrospective
Last update:2018-08-06, 1397/05/15
Update count:0
Registration date
2018-08-06, 1397/05/15
Registrant information
Name
Mohammad Moazeni
Name of organization / entity
Shiraz University
Country
Iran (Islamic Republic of)
Phone
+98 71 3613 8676
Email address
moazeni@shirazu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
2015-04-12, 1394/01/23
Actual recruitment end date
2017-09-05, 1396/06/14
Trial completion date
empty
Scientific title
Clinical efficacy of the essence oil of Zartaria multiflora on human liver hydatid cyst in comparison with Albendazole
Public title
Clinical efficacy of the essence oil of Zartaria multiflora on human liver hydatid cyst
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who accepted the treatment protocol by signing the appropriate informed consent,
Patients with hepatic hydatid cysts smaller than 5 cm,
Patients with uncomplicated hydatid cysts (non calcified and non infected to bacterial infections),
Patients who were not simultaneously infected to pulmonary hydatid disease
Exclusion criteria:
Refusal of treatment at each stage of the treatment period
Patients with symptoms of complicated cysts (infection, abscessation).
Enlargement of the cysts during the course of treatment.
Adverse drug reactions leading to discontinuation of the treatment
Patients who don’t refer for periodic examinations and necessary tests
Recurrence of the disease
Age
From 20 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.Sums.Rec.1396.335
Health conditions studied
1
Description of health condition studied
Hydatid disease (Hydatid cyst)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduction in the size of hydatid cysts
Timepoint
Before the start of treatment and after all treatment periods (totally 4 times)
Method of measurement
By sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 15 patients consumed orally the 20 mg soft capsules of Zataria multiflora essential oil (produced by Barij Essence Pharmaceutical Company, Iran) 3 times a day for 6 months (180 consecutive days). Before the start of treatment and 2, 4 and 6 months after the start of treatment, the size of the cysts were measured by sonography. Simultaneously, biochemical and hematological analysis was performed on the blood samples of patients to assess the possible side effects. At the end of study, the mean size of the cysts and the results of the liver and kidney function tests were compared statistically between the patients of two treatment groups.
Category
Treatment - Drugs
2
Description
Control group: The patients of this group (15 patients) consumed orally the 400 mg tablets of albendazole (produced by CIPLA LTD, India) 2 times a day for 6 months. All measurements and tests were performed exactly as in the intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Dr. Hajar Khazraei
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
44119 - 71348
Phone
+98 71 3235 1087
Fax
+98 71 3233 1634
Email
khazraee@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University
Full name of responsible person
Dr. Mohammad Moazeni
Street address
Bajgah area, School of Veterinary Medicine
City
Shiraz
Province
Fars
Postal code
71441-69155
Phone
+98 71 3228 6950
Fax
+98 71 3228 6940
Email
moazeni@shirazu.ac.ir
Web page address
http://shirazu.ac.ir/vet/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University
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
Shiraz University
Full name of responsible person
Dr. Mohammad Moazeni
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Parasitology
Street address
Bajgah area< School of Veterinary Medicine
City
Shiraz
Province
Fars
Postal code
71441-69155
Phone
+98 71 3228 6950
Fax
+98 71 3228 6940
Email
moazeni@shrazu.ac.ir
Web page address
http://shirazu.ac.ir/vet/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University
Full name of responsible person
Dr. Mohammad Moazeni
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Parasitology
Street address
Bajgah area, School of veterinary Medicine
City
Shiraz
Province
Fars
Postal code
71441-69155
Phone
+98 71 3228 6950
Fax
+98 71 3228 6940
Email
moazeni@shirazu.ac.ir
Web page address
http://shirazu.ac.ir/vet/
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University
Full name of responsible person
Dr. Mohammad Moazeni
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Parasitology
Street address
Bajgah area, School of Veterinary Medicine
City
Shiraz
Province
Fars
Postal code
71441-69155
Phone
+98 71 3228 6950
Fax
+98 71 3228 6950
Email
moazeni@shirazu.ac.ir
Web page address
http://shirazu.ac.ir/vet/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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