Protocol summary

Study aim
Determination of the effect of Rotarin drug on the symptoms and severity of sore throat in patients with bacterial and allergic sore throats compared with placebo
Design
Clinical trial study with control group, with parallel groups, double-blind, randomized by simple randomization method using random numbers table, 80 patients, phase 3
Settings and conduct
In this study, the samples were selected from patients with sore throat who went to the private doctor's office with the Convenience Sampling method and individuals were divided into groups by simple randomization. If patients wish to participate in this research, first the goals and method of conducting the study for patients were explained and then, a written consent was obtained from all volunteer patients. At the beginning of the visit, after recording the severity of the patient's sore throat and completing the quality of life questionnaire, patients were asked to mix 2 sachets of Rotarin in lukewarm water daily for 7 days and drink it in the morning and evening. After 7 days, visit again to record the severity of pain and quality of life questionnaire for each patient. In addition, all patients were asked to take the medication prescribed by their doctor in accordance with the instructions, in addition to taking this herbal medicine.
Participants/Inclusion and exclusion criteria
inclusion criteria: Aged 18-65 years; diagnosis of bacterial and allergic diseases by a physician. Exclusion criteria: Patients' reluctance to participate in the study; Pregnancy and lactation.
Intervention groups
rotarian group, placebo group
Main outcome variables
The severity of the pain; Daily activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140804018677N3
Registration date: 2020-05-04, 1399/02/15
Registration timing: retrospective

Last update: 2020-05-04, 1399/02/15
Update count: 0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
soodeh razeghi Jahromi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8500
Email address
razeghi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-02-09, 1396/11/20
Actual recruitment start date
2017-10-23, 1396/08/01
Actual recruitment end date
2018-02-09, 1396/11/20
Trial completion date
2018-02-20, 1396/12/01
Scientific title
Investigation of the effect of rotarin drug on the symptoms and severity of sore throat in patients with bacterial and allergic sore throats compared with placebo
Public title
Rotarin effect on sore throat in patients with bacterial and allergic sore throats
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of bacterial and allergic diseases by a physician Aged 18-65 years
Exclusion criteria:
Pregnancy and lactation Patients' reluctance to participate in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients were assigned to two groups of Rotarin and placebo based on a Simple randomization method. This means that all participants had an equal chance of being in each group. The first step is to create a random sequence. For this purpose, we used a table of random numbers. From the beginning, it was decided to go down to read the numbers in the table of random numbers, after selecting the starting point. We then determined that even numbers were assigned to the intervention group and individual numbers were assigned to the placebo group. Due to the fact that when using simple randomization methods, especially in low sample size, it is possible that the two groups do not equal at the same time, so if a group reaches its sample size earlier, then we must ignore the relevant figures, and complete the opposite group. One of the project's colleagues put his finger on a point in the table with his eyes closed, and then, as scheduled, moved down and wrote down the numbers until they reached the sample size in both groups. Each number, depending on whether they were even or odd, represented a group to which we assigned code A (intervention) and B (placebo). With this method, we had a specific sequence of 80 codes A and B at the end, indicating that the first to eightieth person to be included in the study should belong to each group. We wrote the code on a piece of paper in order and put it in an envelope, to use it during sampling. Thus, after reviewing the entry criteria and, if the client wishes, we entered each person into the groups according to our pre-determined list.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti medical university
Street address
No. 46, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2018-09-24, 1397/07/02
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.1172

Health conditions studied

1

Description of health condition studied
Patients with bacterial or allergic sore throat
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The severity of the pain
Timepoint
baseline and end of study
Method of measurement
Quality of Life Questionnaire

2

Description
The effect of disease severity on daily activity
Timepoint
baseline and end of study
Method of measurement
Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Rotarin (a combination of Plantago ovata forsk, plantago major, quince seed, basil seed and Merv egg), for 7 days, daily 2 sachets of Rotarin mixed with lukewarm water, morning and evening
Category
Treatment - Drugs

2

Description
Control group: placebo, for 7 days, daily 2 sachets of placebo mixed with lukewarm water, morning and evening
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
private clinic
Full name of responsible person
Soodeh Razeghi Jahromi
Street address
No. 46, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 22357
Email
soodehrazeghi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razeghi Jahromi
Street address
No. 46, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 22357
Email
soodehrazeghi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razghei Jahromi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 46, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 22357
Email
soodehrazeghi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razeghi Jahromi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Province
Tehran
Postal code
4741-19395
Phone
+98 21 22357
Email
soodehrazeghi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razeghi Jahromi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 46, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 22357
Email
soodehrazeghi@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
No - There is not 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
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