Determining the effect of licorice-based product on hoarseness
Design
Randomized, placebo-controlled, single-blind, parallel-group clinical trial, phase 3 on 80 patients, the card shuffle method was used for simple individual randomization
Settings and conduct
Participants with chief complaint of hoarseness who meet the inclusion criteria, are divided into two groups and coded and listed with the letters A (control group) and B (experimental group) by shuffling the cards. The main drug and placebo are delivered to the relevant group in the renamed box with labels A and B, respectively, so that the participants do not know the name of the drug
Participants/Inclusion and exclusion criteria
entry conditions;
- Having a clinical diagnosis of hoarseness
- Despite conventional medical treatment, there is no
satisfactory recovery
- No previous diagnosis of laryngeal mass and malignancy
- Absence history of chronic diseases in which licorice is
contraindicated
-Do not take drugs that interact with licorice
No entry conditions;
- Diagnosis of mass and malignancy or factors suspected of
laryngeal malignancy
- Taking drugs that interact with licorice
- Presence of hypertension, heart disease with edema, kidney
and liver diseases
- Pregnancy
- Smoking
- Hypersensitivity to licorice
Intervention groups
The intervention group will receive 4 tablets containing one gram of licorice extract daily for two weeks; and the control group will receive the placebo, which is completely similar to the herbal product in terms of color, appearance, taste and size, for two weeks with the same number and conditions
Main outcome variables
Hoarseness Score in VHI Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210906052391N1
Registration date:2021-11-29, 1400/09/08
Registration timing:retrospective
Last update:2021-11-29, 1400/09/08
Update count:0
Registration date
2021-11-29, 1400/09/08
Registrant information
Name
Mostafa Solati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3337 2715
Email address
solati.mostafa@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
2018-11-03, 1397/08/12
Actual recruitment end date
2021-02-25, 1399/12/07
Trial completion date
2021-02-25, 1399/12/07
Scientific title
Evaluation of the effect of licorice-based lozenge on hoarseness/dysphonia
Public title
licorice in hoarseness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a clinical diagnosis of hoarseness
Despite conventional medical treatment, there is no satisfactory recovery
No previous diagnosis of laryngeal mass and malignancy
Absence history of chronic diseases in which licorice is contraindicated
Do not take drugs that seriously interfere with licorice
Exclusion criteria:
Diagnosis of mass and malignancy or factors suspected of laryngeal malignancy
Taking drugs that seriously interfere with licorice
Presence of hypertension, heart disease with edema, kidney and liver diseases
Pregnancy
Smoking
Hypersensitivity to licorice
Age
From 18 years old to 55 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Actual sample size reached:
39
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization by shuffling cards In such a way that; 40 cards are considered as the experimental group with the letter B and the same number of cards for the control group with the letter A; Then, by shuffling the cards, a card is taken out and its allocation is recorded. Then the cards are dealt again and another card is taken out. This process continues until a random sequence is reached according to the sample size
Blinding (investigator's opinion)
Single blinded
Blinding description
The intervention group will receive 4 tablets containing one gram of licorice extract daily for two weeks; and the control group will receive the placebo, which is completely similar to the herbal product in terms of color, appearance, taste and size, for two weeks with the same number and conditions
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Faculty of Iranian Medicine, Intersection of Hafez St. with Behesht St
The effect of hoarseness on daily life, before the intervention
Timepoint
At the beginning of the study, before the intervention
Method of measurement
Mean score of quality of life using voice disability index (VHI) questionnaire before intervention
2
Description
The degree of change in hoarseness and its effect on daily life after the intervention
Timepoint
14 days after the intervention
Method of measurement
Mean score of quality of life using vocal disability index (VHI) questionnaire after intervention
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group takes 4 lozenges one after another in one meal every day. Without consuming it with water or food. The duration of use is 14 days. Each tablet contains 250 mg of licorice extract, so the total consumption of licorice extract will be one gram per day. This drug has been prepared as a pilot research in collaboration with Touba Green Gold Institute in the tablet factory
Category
Treatment - Drugs
2
Description
Control group: The control group takes 4 placebo lozenges one after the other in one meal every day. Without consuming it with water or food. The duration of use is 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of the Faculty of Iranian Medicine
Full name of responsible person
Mostafa Solati
Street address
Faculty of Iranian Medicine, Behesht St., Islamic Vahdat St.
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5558 0388
Email
solati.mostafa@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Soleimani
Street address
Faculty of Iranian Medicine, Behesht St., Islamic Vahdat St.
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5558 0388
Email
Solati.Mostafa@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mostafa Solati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian Medicine, Behesht St., Islamic Vahdat St.
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5558 0388
Email
Solati.Mostafa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mostafa Solati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian Medicine, Behesht St., Islamic Vahdat St.
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5558 0388
Email
Solati.Mostafa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mostafa Solati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian Medicine, Behesht St., Islamic Vahdat St.
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5558 0388
Email
Solati.Mostafa@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
All data related to biographical information and self-reported scores of patients can be shared with the potential voice disability questionnaire after identifying individuals.
When the data will become available and for how long
6months after the publication of the results
To whom data/document is available
Everyone can access the data
Under which criteria data/document could be used
There are no other special conditions for accessing the documents
From where data/document is obtainable
Applicants for correspondence can contact Dr. Mostafa Solati via the following email address. Solati.Mostafa@yahoo.com
What processes are involved for a request to access data/document
After sending the request via email, the request will be reviewed and answered within a week or so