Determining the effect of Ardor syrup on the severity of functional bloating in the elderly
Design
Clinical trial with a control group, with a parallel group, double-blind, randomized, phase 3 on 72 patients for 4 weeks.
Settings and conduct
Samples that meet the enclusion criteria will be selected from those who refer to the specialized clinics of Mazandaran University of Medical Sciences located in Sari city, and the block method will be used to allocate the samples. 12 blocks of 6 will be created and the samples will be assigned to each of the blocks and groups accordingly. It should be noted that three samples from the drug group and three samples from the placebo group will be placed in each block
Participants/Inclusion and exclusion criteria
- People older than 60 years, whose Functional bloating has been confirmed by a Gastroenterologist based on Rome III criteria
- Consent of the individual for voluntary participation in research
- History of takes Anti H. pylori medicine in the last tree months
- Patients with a History of stomach or intestinal surgery
- Patients with diabetes or severe mental illness
- Patients who take antibiotics
- History of allergy to Herbal medicines
Intervention groups
Ardor syrup group
Placebo syrup group
Main outcome variables
Intensity of bloating
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230316057734N1
Registration date:2023-06-24, 1402/04/03
Registration timing:prospective
Last update:2023-06-24, 1402/04/03
Update count:0
Registration date
2023-06-24, 1402/04/03
Registrant information
Name
Mokhtar Hedayati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3330 9082
Email address
m@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Ardor syrup on the severity of functional bloating in the elderly
Public title
The effect of Ardor syrup on the severity of functional bloating in the elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People older than 60 years, whose Functional bloating has been confirmed by a Gastroenterologist based on Rome III criteria
Consent of the individual for voluntary participation in research
Exclusion criteria:
History of taking Anti H. pylori medicine in the last tree months.
Patients with a History of stomach or intestinal surgery
Patients with diabetes or severe mental illness
Patients who take antibiotics
History of allergy to Herbal medicines
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the samples will be determined and the blocking method will be used to allocate the samples. This process will be done with Random allocation software. With this software, 12 block of 6 will be created and the samples will be assigned to each of the blocks and groups accordingly. It should be noted that three samples from the drug group and three samples from the placebo group will be placed in each block with A or B signs.
Blinding (investigator's opinion)
Double blinded
Blinding description
The medicines and placebos will be prepared in the same color and packaging bottle, and before the intervention will be coded by a statistical expert cooperator, so that the researcher and the patient will not know the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences, Teacher Street, Teacher's Square
City
Sari
Province
Mazandaran
Postal code
48168-95474
Approval date
2023-06-10, 1402/03/20
Ethics committee reference number
IR.MAZUMS.REC.1402.114
Health conditions studied
1
Description of health condition studied
Bloating
ICD-10 code
R14
ICD-10 code description
Flatulence and related conditions
Primary outcomes
1
Description
Intensity of bloating
Timepoint
Measuring the intensity of bloating before the study (day zero), 7, 14, 21, 28
The day before starting the study (day zero), 7, 14, 21, 28
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Arder syrup, 5 cc every 12 hours until one hour after meals. (Arder syrup consists of Pimpinella anisum seed, Foeniculum vulgare seed, Apium graveolens seed, Rosa damascene petal and Crocus sativus stigma.
Category
Treatment - Drugs
2
Description
Control group: Placebo syrup, will be prepared in the same color and container as drug syrup, 5 cc every 12 hours until one hour after meals.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari, specialized clinic of Mazandaran University of Medical science
Full name of responsible person
Asieh Jokar
Street address
Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3014
Email
a.jokar@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Omran Habibi
Street address
Moalem St.Research and Technology Vice-Chancellor of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Asieh Jokar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Traditional and Complementary Medicine Research Center of Mazandaran University, Khazar Blvd, Khazar Square
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 4893
Email
a.jokar@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Asieh Jokar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Traditional and Complementary Medicine Research Center of Mazandaran University, Khazar Blvd, Khazar Square
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 3117
Email
a.jokar@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mokhtar Hedayati
Position
Persian Medicine student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Traditional and Complementary Medicine Research Center of Mazandaran University, Khazar Blvd, Khazar Square
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3310 9650
Email
dr.m.acur@gmail.com
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
Not applicable
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available