Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12613000584730
Ethics application status
Approved
Date submitted
16/05/2013
Date registered
24/05/2013
Date last updated
9/12/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
Effects of a traditional Persian medicine syrup (Jollab) on Functional Dyspepsia patients
Query!
Scientific title
Survey on a traditional Iranian medicine syrup (Jollab) in relieving gastrointestinal symptoms in Functional Dyspepsia (FD) patients: a randomized double-blind placebo-controlled clinical trial
Query!
Secondary ID [1]
282518
0
None
Query!
Universal Trial Number (UTN)
U1111-1143-1766
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Functional Dyspepsia
289181
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
289502
289502
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Alternative and Complementary Medicine
289571
289571
0
0
Query!
Other alternative and complementary medicine
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
A traditional Persian medicine syrup named Jollab, is administered orally 3 times daily, 45 milliliters totally, during 4 weeks. this syrup is a combination of distilled water, Rose water, Saffron and Sugar as mentioned in Avicenna's book (Al-Qanoon fil-teb). As the active agents have synergistic effect, there isn't way to specify the active ingredients amount.
In order to monitor adherence, patient should check a form and render this form in follow-up meetings.
Query!
Intervention code [1]
287178
0
Treatment: Other
Query!
Comparator / control treatment
A combination of distilled water, Standard dye material and 5% Rose water
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
289607
0
Relief in Gastrointestinal symptoms in functional dyspepsia patients assessed by Leeds Questionaire
Query!
Assessment method [1]
289607
0
Query!
Timepoint [1]
289607
0
0- Baseline
1- At two weeks after the beginning of trial
2- At one month after the beginning of trial
3- At two months after the beginning of trial
Query!
Secondary outcome [1]
302839
0
Depression as assessed using Beck Questionaire
Query!
Assessment method [1]
302839
0
Query!
Timepoint [1]
302839
0
Baseline, and at 4 weeks after the beginning of intervention
Query!
Secondary outcome [2]
302842
0
Quality of life as assessed using SF-36 Questionaire
Query!
Assessment method [2]
302842
0
Query!
Timepoint [2]
302842
0
Baseline, and 2 months after the beginning of intervention
Query!
Eligibility
Key inclusion criteria
1- Functional Dyspepsia (FD) patients according to Rome III criteria, based on general exam and gastrointestinal endoscopy
2- Normal range of lab data (CBC, LFT, Stool exam)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1- Steatorrhoea 2- Celiac disease 3- Night Diarrhea 4- Beginning of FD after the age of 40 years 5- Cancer (any form) 6- Liver disease 7- Pulmonary disease 8- Auto-immune disease 9- Psychiatry disease 10- pregnancy 11- Lactation 12- Irritable Bowl Syndrome (IBS) 13- History of Abdominal Surgery 14- Treatment with Lactolose or similar drugs 15- Consumption of drugs contributed to FD simultaneously 16- Consumption of Analgesic or Narcotic drugs
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
1/06/2013
Query!
Actual
1/06/2013
Query!
Date of last participant enrolment
Anticipated
31/12/2013
Query!
Actual
16/10/2013
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
150
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
5084
0
Iran, Islamic Republic Of
Query!
State/province [1]
5084
0
Fars
Query!
Funding & Sponsors
Funding source category [1]
287300
0
University
Query!
Name [1]
287300
0
Shahid Beheshti University of Medical Science
Query!
Address [1]
287300
0
Tehran State,
Tehran,
Velenjak Str. , Shahid Chamran Highway,
Postcode: 1985717443
Query!
Country [1]
287300
0
Iran, Islamic Republic Of
Query!
Primary sponsor type
University
Query!
Name
Shahid Beheshti University of Medical Science
Query!
Address
Tehran State,
Tehran,
Velenjak Str. , Shahid Chamran Highway,
Postcode: 1985717443
Query!
Country
Iran, Islamic Republic Of
Query!
Secondary sponsor category [1]
286053
0
None
Query!
Name [1]
286053
0
Query!
Address [1]
286053
0
Query!
Country [1]
286053
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
289276
0
Shahid Beheshti University of Medical Science Ethics Committee
Query!
Ethics committee address [1]
289276
0
Tehran State,
Tehran,
Velenjak Str. , Shahid Chamran Highway,
Postcode: 1985717443
Query!
Ethics committee country [1]
289276
0
Iran, Islamic Republic Of
Query!
Date submitted for ethics approval [1]
289276
0
Query!
Approval date [1]
289276
0
Query!
Ethics approval number [1]
289276
0
Query!
Summary
Brief summary
Functional Dyspepsia (FD) is a widespread disease in community. The pathophysiology of Fd is not clearly evident, yet. The disease has a huge expense for health system and the treatments aren't sufficient unfortunately.
Traditional Persian Medicine originated from the knowledge of great physicians like Avicenna, presented herbal drugs which have been used by people for hundreds years.
An inexpensive accessible Persian herbal syrup named as Jollab has been introduced in Traditional Persian Medicine books repeatedly.
The aim of this study is to evaluate the efficacy of Jollab in relieveing symptoms of FD.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
40130
0
Dr Mehdi Pasalar
Query!
Address
40130
0
Postal Code:71888-37187
no. 2
Nikan Building,
Lane 21/2,
Mirzay-e-Shirazi Bulvard,
Shiraz
Shiraz University of Medical Sciences
Query!
Country
40130
0
Iran, Islamic Republic Of
Query!
Phone
40130
0
+989173121345
Query!
Fax
40130
0
Query!
Email
40130
0
[email protected]
Query!
Contact person for public queries
Name
40131
0
Dr Mehdi Pasalar
Query!
Address
40131
0
Postal Code:71888-37187
no. 2
Nikan Building,
Lane 21/2,
Mirzay-e-Shirazi Bulvard,
Shiraz
Shiraz University of Medical Sciences
Query!
Country
40131
0
Iran, Islamic Republic Of
Query!
Phone
40131
0
+989173121345
Query!
Fax
40131
0
Query!
Email
40131
0
[email protected]
Query!
Contact person for scientific queries
Name
40132
0
Prof Kamran Bagheri Lankarani
Query!
Address
40132
0
Shiraz University of Medical Sciences,
Health policy Research Center, Building No 2, Eighth Floor, School of Medicine, Zand Avenue, Shiraz, Iran, Postal code: 7134853185
Query!
Country
40132
0
Iran, Islamic Republic Of
Query!
Phone
40132
0
+987112309615
Query!
Fax
40132
0
Query!
Email
40132
0
[email protected]
Query!
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Efficacy and safety of jollab to treat functional dyspepsia: A randomized placebo-controlled clinical trial.
2015
https://dx.doi.org/10.1016/j.explore.2015.02.007
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF