The aim of this study was to determine the effect of traditional medicine product based on rose on gastroesophageal reflux disease (GERD).
Design
Controlled clinical trial with parallel groups. A randomized, double-blind, phase 3 study is performed on 70 patients.
Settings and conduct
Patients referred to the gastrointestinal clinic of Imam Hossein Hospital are randomly divided into two groups. Roses and placebo capsules for the same package and will be encrypted. Coding is done blindly. Placebo is used for medicinal corn starch. Patients in the drug group use rose capsules and placebo capsules. Both groups received Abaidi omeprazole capsules. In the beginning, after two weeks and in the fourth week, the patients have visited, and the reflux questionnaire is completed.
Participants/Inclusion and exclusion criteria
Patients with Gastro-Esophageal Reflux Disease aged 18 to 80 years. Exclusion criteria: having a history of Barrett's esophagus, history of esophageal or gastric surgery; History of esophageal, gastric, or abdominal cancer; Having coagulation problems that prevent them from stopping their medication.
Intervention groups
Intervention group: Rose capsule, this capsule is prepared in Tuba Green Gold Pharmaceutical Company. Patients take one rose capsule 3 times a day after each meal for 4 weeks.
Control group: Placebo, this capsule is prepared in Tuba Green Gold Pharmaceutical Company. Patients take one capsule 3 times a day after each meal for 4 weeks.
Main outcome variables
Heartburn؛ Reflux throat؛ Pain in the middle and upper stomach ؛Nausea؛ Difficulty in falling asleep due to reflux symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200303046677N5
Registration date:2021-01-16, 1399/10/27
Registration timing:prospective
Last update:2021-01-16, 1399/10/27
Update count:0
Registration date
2021-01-16, 1399/10/27
Registrant information
Name
rasool choopani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
rchoopani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of traditional medicine product based on Rosa damascena on gastroesophageal reflux disease (GERD): a double-blind clinical trial
Public title
Effect of traditional medicine product based on Rosa damascena on gastroesophageal reflux disease (GERD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
With reflux at the age of 18 to 80 years
Exclusion criteria:
Having a history of Barrett's esophagus
History of esophageal or gastric surgery
History of esophageal, gastric or abdominal cancer
Having coagulation problems that prevent them from stopping their medication
Patients receiving regular glucocorticoids and nonsteroidal anti-inflammatory drugs more than three days a week for the past 28 days
Receiving sucralfate three days before enrollment
Take aspirin daily at a dose of more than 150 mg
Acute peptic ulcer or its complications
Receive antibiotic treatment to eradicate Helicobacter Pylori in the last 28 days
Smoking or Alcohol
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
A randomization table was created with the Excel software rand option. It was already clear that the process of reading random numbers was from top to bottom. Therefore, 35 random codes were assigned to the drug group and written on the drug, and the next 35 codes were written on the placebo, and the codes were kept confidential for use at the time of conclusion. The drugs were packed in the same containers, coded, and given to the researcher and the physician in an identical. Patients randomly received one of the containers of medication or placebo.
Randomization unit: individual
Randomization tool: Random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization is done by Excel software and by a researcher who has no involvement in the study. The codes are then written on the same container of medicine and placebo and will be kept confidentially in an envelope until the end of the study. The prescribing physician, assistant, And the patient will not be aware of the capsules' contents until the end of the study (double-blind).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences
Difficulty in falling asleep due to reflux symptoms
Timepoint
On arrival, the second week and fourth week
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Placebo, this capsule is prepared in Tuba Green Gold Pharmaceutical Company and medicinal corn starch is used as a placebo, which is filled in capsules of the same color and size of the drug and packed in similar containers. Patients take one capsule 3 times a day after each meal for 4 weeks.
Category
Placebo
2
Description
Intervention group: Rose capsule, this capsule is prepared in Tuba Green Gold Pharmaceutical Company. It contains 10 units of rose (petals), 2 units of licorice (dry extract), valerian (root) and 1 part of turpentine (gum) each. The drug components are ground and filled in 500 mg capsules. Quality control of product components, microbial and fungal tests of components and the final product are performed based on valid pharmacopoeias. Patients take one rose capsule 3 times a day after each meal for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology Clinic of Imam Hossein Hospital
Full name of responsible person
Habib Malekpour
Street address
Shahid Madani Ave - Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
habib.malekpour@gmial.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Somayeh Esmaeili
Street address
No.8, shams Ali, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
sesmaeili@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rasool Choopani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.8, Valiasr Ave., Shams Ali
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
rchoopani@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rasool Choopani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Valiasr
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Fax
Email
rchoopani@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rasool Choopani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.8, Valiasr Ave., Shams Ali
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
rchoopani@sbmu.ac.ir
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
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