ANZCTR - Registration

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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

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

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1143-1766

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Functional Dyspepsia

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Alternative and Complementary Medicine

Other alternative and complementary medicine

Intervention/exposure

Study type

Interventional

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.

Intervention code [1]

Treatment: Other

Comparator / control treatment

A combination of distilled water, Standard dye material and 5% Rose water

Control group

Placebo

Outcomes

Primary outcome [1]

Relief in Gastrointestinal symptoms in functional dyspepsia patients assessed by Leeds Questionaire

Timepoint [1]

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

Secondary outcome [1]

Depression as assessed using Beck Questionaire

Timepoint [1]

Baseline, and at 4 weeks after the beginning of intervention

Secondary outcome [2]

Quality of life as assessed using SF-36 Questionaire

Timepoint [2]

Baseline, and 2 months after the beginning of intervention

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)

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

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

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

numbered containers

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation

Masking / blinding

Blinded (masking used)

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

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2013

Actual

1/06/2013

Date of last participant enrolment

Anticipated

31/12/2013

Actual

16/10/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

150

Accrual to date

Final

Recruitment outside Australia

Country [1]

Iran, Islamic Republic Of

State/province [1]

Fars

Funding & Sponsors

Funding source category [1]

University

Name [1]

Shahid Beheshti University of Medical Science

Address [1]

Tehran State,
Tehran,
Velenjak Str. , Shahid Chamran Highway,
Postcode: 1985717443

Country [1]

Iran, Islamic Republic Of

Primary sponsor type

University

Name

Shahid Beheshti University of Medical Science

Address

Tehran State,
Tehran,
Velenjak Str. , Shahid Chamran Highway,
Postcode: 1985717443

Country

Iran, Islamic Republic Of

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Shahid Beheshti University of Medical Science Ethics Committee

Ethics committee address [1]

Tehran State,
Tehran, 
Velenjak Str. , Shahid Chamran Highway,
Postcode: 1985717443

Ethics committee country [1]

Iran, Islamic Republic Of

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Mehdi Pasalar

Address

Postal Code:71888-37187
no. 2
Nikan Building,
Lane 21/2,
Mirzay-e-Shirazi Bulvard,
Shiraz
Shiraz University of Medical Sciences

Country

Iran, Islamic Republic Of

Phone

+989173121345

Fax

pasalar@sums.ac.ir

Contact person for public queries

Name

Mehdi Pasalar

Address

Postal Code:71888-37187
no. 2
Nikan Building,
Lane 21/2,
Mirzay-e-Shirazi Bulvard,
Shiraz
Shiraz University of Medical Sciences

Country

Iran, Islamic Republic Of

Phone

+989173121345

Fax

pasalar@sums.ac.ir

Contact person for scientific queries

Name

Kamran Bagheri Lankarani

Address

Shiraz University of Medical Sciences,
Health policy Research Center, Building No 2, Eighth Floor, School of Medicine, Zand Avenue, Shiraz, Iran, Postal code: 7134853185

Country

Iran, Islamic Republic Of

Phone

+987112309615

Fax

lankaran@sums.ac.ir

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.

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Documents added manually

Documents added automatically