Determining the effect of a traditional Iranian herbal compound in treatment of functional dyspepsia.
Design
A double-blind clinical trial with parallel groups is performed on 150 patients (105 in the drug group and 45 in the placebo group); Randomization is done by block randomization. Random Sequence generation will also be done using Randomizer software.
Settings and conduct
Patients of dyspepsia who have not responded to common treatments of internist or gastroenterologist in Imam Reza specialized clinic in Shiraz will be referred to enter the plan.
After the patient enters, the block related to him is determined by the questioner and from that block he gives a code to the patient and delivers 28 sachets with that code to the patient.The place of questioning and providing medicine is Imam Reza specialized clinic in Shiraz.
Participants & service providers are blinded to the intervention. The pharmacologist and statistician are aware of the contents of the sachets (drug or placebo).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women with one of the symptoms of ROME4 criteria for dyspepsia those are between 18-65 years old. Exclusion criteria: dyspepsia with organic causes, pregnant women, having plan to conceive through the study duration, lactating women, positive history of chronic liver diseases, renal diseases, malignancies and diabetes, taking anticoagulants including warfarin, Plavix, aspirin and other chemical agents, and herbal remedies that may be considered as confounding factors for this study؛ History of allergic reaction to components of drug and placebo.
Intervention groups
Drug group that receive sachets containing the drug composition.
Placebo group that receive the sachet containing the placebo.
Main outcome variables
Reduction of "postprandial fullness", "postprandial satiety", "epigastric pain" and "epigastric burning"
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220304054179N1
Registration date:2022-04-13, 1401/01/24
Registration timing:registered_while_recruiting
Last update:2022-04-13, 1401/01/24
Update count:0
Registration date
2022-04-13, 1401/01/24
Registrant information
Name
soodabeh samimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3624 8075
Email address
samimisoodabeh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-12, 1400/12/21
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the efficacy of an iranian traditional herbal compound in treatment of functional dyspepsia, add-on double blind randomized controlled trial
Public title
The efficacy of an iranian traditional herbal compound in treatment of dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 years old
Men and women
Patients with one of the symptoms of ROME4 dyspepsia.
Exclusion criteria:
Dyspepsia with organic causes
Pregnant women, having plan to conceive through the study duration
Lactating women
Positive history of chronic liver diseases, renal diseases, diabetes and malignancies
Taking anticoagulants including warfarin, Plavix, aspirin and other chemical agents, and herbal remedies that may be considered as confounding factors for this study.
Positive history of allergic reaction to "Anise", "Fennel", "Trachyspermum", "Caraway" and "Placebo composition"(Corn and wheat and barley).
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
This study is an add-on double blind randomized controlled trial study, and only statisticians know which code is drug or placebo and the questioner and patient are blinded. randomized allocation is done using block randomization; In blocking, variables such as age and sex and routine drug use and severity of symptoms will be considered. Random Sequence generation will also be done using Randomizer software.
After the patient enters, the necessary explanations about the plan are provided to him and then his consent is received in the form of consent and his registration is done, based on the variables related to blocking (such as age, sex and routine medication) He is assigned, and from the codes in that block, a code is randomly assigned to the patient and the sachet with that code is delivered to the patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants & Questioner are blinded by the end of the project.
The pharmacologist is aware of the contents of the sachets (drug or placebo).
The statistician who prepares the blocks and tables of random numbers is aware of the content of the codes (drug or placebo).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand Ave.
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2022-01-17, 1400/10/27
Ethics committee reference number
IR.SUMS.MED.REC.1400.570
Health conditions studied
1
Description of health condition studied
Dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia
Primary outcomes
1
Description
Postprandial fullness
Timepoint
2 weeks
Method of measurement
Gastrointestinal Symptoms Severity Questionnaire
Secondary outcomes
1
Description
Epigastric pain&burning sensation
Timepoint
2 weeks
Method of measurement
Gastrointestinal Symptoms Severity Questionnaire
Intervention groups
1
Description
Intervention group: This group receives the drug, which contains a traditional herbal composition. the components of the product include the seeds of the anise plant and the seeds of the fennel plant and the seeds of the Trachyspermum plant and the seeds of the caraway plant, which are grinded and placed in 8-gram sachets by traditional medicine pharmacist in the drug manufacturing center located in Emam Reza Clinic. Each patient is given 28 sachets. The method of taking the medicine is one sachet in the morning before breakfast and one sachet at night at bedtime, which is consumed with half a glass of water, and the treatment period is two weeks.
Category
Treatment - Drugs
2
Description
Control group: The group that receives placebo. The placebo includes corn starch, wheat bran and barley flakes and 10% of the herbal composition of the drug (to simulate the appearance of the drug), which is prepared by a traditional medicine pharmacist in the drug manufacturing center located in Emam Reza Clinic in Shiraz and placed in 8 gram sachets.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam-reza clinic
Full name of responsible person
Soodabeh samimi
Street address
Zand Ave.
City
Shiraz
Province
Fars
Postal code
۱۴۷۳۴-۷۱۳۴۸
Phone
+98 71 3212 7000
Fax
+98 71 3647 4673
Email
samimisoodabeh@sums.ac.ir
Web page address
https://emamreza.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Kamyar Zomorrodian
Street address
Zand Ave.
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3212 2430
Fax
+98 71 3212 2430
Email
samimisoodabeh@sums.ac.ir
Web page address
https://rde.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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 of Medical Sciences
Full name of responsible person
Soodabeh Samimi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Zand Ave., School of Medicine, 7th Floor, Department of Iranian Traditional Medicine