Explaining tonsil enlargement in Persian medicine and study the effect of blackberry paste on tonsil hypertrophy
Design
The clinical trial is two-blind and random. The random assignment of patients to intervention and control is done by the method of quadruple random blocks and by a statistical consultant. 72 envelopes are prepared and in each envelope, the letter A or B is placed and will be numbered from 1 to 72. The letter A will belong to the intervention group and the letter B will belong to the control group. The sample size in each group is 36 people and in total 72 people.
Settings and conduct
Clinical trials in the field of traditional medicine will be performed in patients of Toobi Clinic in Sari and Bouali Specialized Clinic in Sari. Random assignment of patients to intervention and control is done by a statistician who does not have access to patients. There is no medicine or placebo inside.
Participants/Inclusion and exclusion criteria
Conditions for patients with tonsillar hypertrophy older than 5 years and younger than 15 years who want to participate in this project and use traditional medicine products. Withdrawal conditions include acute tonsillitis, tonsillar abscess, unstable clinical condition, systemic corticosteroid use or antibiotics from 4 weeks ago, allergy to blackberry and honey, symptoms of incompatibility with consumption of blackberry product, inability to communicate and unwillingness of the patient to Continuation of cooperation in the study
Intervention groups
Includes intervention and control groups. In the intervention group, patients were given blackberry oral syrup for 4 weeks and the control group was given placebo for 4 weeks.
Main outcome variables
Tonsil size, Dysphagia, nasal speech, mouth breathing during sleep, snoring at night before and 4 weeks after intervention; Tonsillectomy was performed 4 and 12 weeks after the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220315054291N1
Registration date:2022-08-10, 1401/05/19
Registration timing:registered_while_recruiting
Last update:2022-08-10, 1401/05/19
Update count:0
Registration date
2022-08-10, 1401/05/19
Registrant information
Name
Mohammadali Pourabbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3324 3117
Email address
dr_pourabbasi.ma@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of blackberry syrup on reducing hypertrophy of tonsils and its clinical symptoms in patients aged 5 to 15 years
Public title
Effect of blackberry syrup on tonsil hypertrophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic tonsillar hypertrophy
Being in the age range of 5 to 15 years
Willingness to participate in this research
Tendency to consume traditional medicine medicinal products
Exclusion criteria:
Having Acute tonsillitis
Having tonsillar abscess
Having unstable clinical conditions
Take systemic corticosteroids 4 weeks before the intervention
Take antibiotics 4 weeks before the intervention
Sensitivity to blackberry
Sensitivity to honey
Demonstrate signs of incompatibility with the consumption of blackberry syrup
Inability to communicate
Patient's unwillingness to continue cooperating in the study
Age
From 5 years old to 15 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
In this study, random assignment of patients to experimental and control groups will be done using the quadruple random blocks method. We know that the number of possible blocks of four of the two letters A and B is equal to 6; As follows:
(AABB-ABAB-ABBA-BAAB-BABA-BBAA)
If we denote them by the numbers 1 to 6, to randomly assign them using blocks of 4, first by throwing 18 regular hexagons, a random sequence of numbers 1 to 6 into 18 blocks of 4 from the sub-generated blocks Will: In the desired sequence, there will be 36 letters from each letter A and B. According to the above blocks, 72 envelopes will be prepared and in each envelope, the letter A or B will be placed and will be numbered from 1 to 72. The person delivering the envelopes to the patients does not know what is inside. The production of a random sequence is done by a statistics and methodology consultant who does not have access to patients and only he knows what is in each issue. Patients who received the letter A will be in the intervention group and patients who received the letter B will be in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients with tonsillar hypertrophy are randomly divided into intervention and placebo groups according to the inclusion criteria. After random sampling and determining whether the patient belongs to the intervention or control group, it is justified by the clinical caregiver and The required training is provided and the package containing the guide and medication brochure will be delivered to patients. In addition to oral explanations about how to study, how to use the drug, the amount and time of use and frequency and duration of treatment are explained. Intervention and control groups will be performed using the quadruple random blocks method.
According to the above blocks, 72 envelopes will be prepared and in each envelope, the letter A or B will be placed and will be numbered from 1 to 72. The person delivering the envelopes to the patients does not know what is inside. The production of a random sequence is done only by a "statistics and methodology consultant" who does not have access to patients and only he knows what is in each issue. Patients who received the letter A in the intervention group and patients who received the letter B. All patients will not be aware of the type of drug in the package, including one of the placebo or the main drug under study.
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
Khazar Boulevard, next to Touba Clinic, Faculty of Traditional Medicine, second floor
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۸۹۵۴۷۵
Approval date
2022-03-19, 1400/12/28
Ethics committee reference number
IR.MAZUMS..REC.1400.11548
Health conditions studied
1
Description of health condition studied
Tonsil hypertrophy
ICD-10 code
J35.1
ICD-10 code description
Hypertrophy of tonsils
Primary outcomes
1
Description
The size of the tonsils according to the Brodsky scale
Timepoint
Beginning of the study (before the intervention)
Method of measurement
Tonsil size classification with Brodsky scale
Secondary outcomes
1
Description
The size of the tonsils according to the Brodsky scale
Timepoint
4 weeks after intervention (after taking blackberry syrup or placebo)
Method of measurement
Tonsil size classification with Brodsky scale
Intervention groups
1
Description
Intervention group: patients slowly eat blackberry syrup for 4 weeks by taking one tablespoon of 5 cc in patients three times a day including morning, noon and night (about 10 seconds) should be kept in the mouth and not swallowed quickly to provide more contact between the syrup and the pharynx and tonsils. Blackberries and 30% honey are prepared by a reputable pharmaceutical factory under sterile conditions and during the pharmaceutical and pharmaceutical processing stages in 120 cc jars. Honey is used as a reformer of blackberries in this product. Blackberries are rich in polyphenols. Among them is anthocyanin, which is a strong antioxidant. Anthocyanin has strong antioxidant, anti-proliferative, and anti-inflammatory properties that can be used in the treatment or prevention of inflammatory diseases and prevent the inappropriate growth and proliferation of cells. Patients are treated by the assistant of traditional medicine. justified and provide the necessary training and recommendations Parents of the patients are explained and trained on how to conduct the study, how to use the drug under study. In addition, during one month, they should observe the necessary precautions in case of tonsillitis, including avoiding drinking very cold liquids, ice water, consuming vinegar, and pickles. Outside the house and washing hands and face after entering the house will be emphasized. In addition to providing verbal explanations, a brochure containing necessary recommendations has been prepared and will be delivered to the patients along with the medicine.
Category
Treatment - Drugs
2
Description
Control group: For 4 weeks, patients slowly eat the placebo oral syrup by taking one tablespoon of 5 cc, three times a day including morning, noon and night after meals, and it will be recommended to take the syrup a little longer (about 10 seconds) should be kept in the mouth and not swallowed quickly. Placebo oral syrup is a combination of water, glucose and permitted food coloring, which is prepared by a reputable pharmaceutical factory under sterile conditions and during the pharmaceutical and pharmaceutical processing stages in 120 cc bottles.The patients are justified by the traditional medicine assistant and the necessary training and recommendations are provided. The parents of the patients are taught that during one month, the necessary precautions for tonsillitis, including avoiding drinking very cold liquids, ice water, and consuming vinegar Also, it will be emphasized on the necessity of following health protocols in order to prevent the occurrence of infections such as colds, including wearing a mask outside the house and washing hands and face after entering the house. It includes the necessary recommendations that will be delivered to the patients along with the medicine Headed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Touba Sari Specialized Clinic
Full name of responsible person
Pourabbasi Mohammadali
Street address
Sari, Khazar Boulevard, Toobi Specialized Clinic
City
Sari
Province
Mazandaran
Postal code
4816895476
Phone
+98 11 3565 5939
Fax
+98 11 3565 5939
Email
dr_pourabbasi.ma@yahoo.com
Web page address
https://www.mazums.ac.ir
2
Recruitment center
Name of recruitment center
Bu Ali Sina Hospital, Sari
Full name of responsible person
Pourabbasi Mohammadali
Street address
Sari, Pasdaran Boulevard, Bu Ali Sina Hospital
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3018
Fax
+98 11 3334 3018
Email
dr_pourabbasi.ma@yahoo.com
Web page address
https://boalihospital.mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Sari, Vice Chancellor for Research and Technology, Mazandaran University of Medical Sciences, Moallem St., Moallem Sq.,
City
Gorgan
Province
Mazandaran
Postal code
4815858477
Phone
+98 11 3325 7230
Fax
+98 11 3325 7230
Email
dr_pourabbasi.ma@yahoo.com
Web page address
https://research.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
Yousefi Seyedeh Sedigheh
Position
Profesor asistente
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Khazar Square, Khazar Boulevard, Center for Traditional and Complementary Medicine, Mazandaran University
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4893
Fax
+98 11 3324 4894
Email
s.yousefi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Yousefi Seyedeh Sedigheh
Position
Profesor asistente
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Khazar Square, Khazar Boulevard, Center for Traditional and Complementary Medicine, Mazandaran University
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4893
Fax
+98 11 3324 4894
Email
s.yousefi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pourabbasi Mohammadali
Position
PhD student in Iranian medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Khazar Square, Khazar Boulevard, Center for Traditional and Complementary Medicine, Mazandaran University
City
Gorgan
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4893
Fax
+98 11 3324 4894
Email
dr_pourabbasi.ma@yahoo.com
Web page address
https://www.mazums.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