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Comparison of the effect of oral gel pilocarpine 2% and ginger 25% in patients with dry mouth after radiotherapy

Protocol summary

Study aim
Comparing the effect of oral gel pilocarpine 2% and ginger 25% in patients with dry mouth after radiotherapy
Design
30 people were divided into 2 groups of 15 people. The study was designed as a double-blind study
Settings and conduct
Determining the effect of pilocarpine 2% oral gel and ginger 25% in patients with dry mouth 3 months after radiotherapy in patients referred to the Department of Oral and Maxillofacial Diseases, Faculty of Dentistry, Tehran Islamic Azad University of Medical Sciences and Bo Ali Hospital in 1402-1403 The study will be conducted as a double blind/randomized controlled clinical trial on volunteer patients with dry mouth.
Participants/Inclusion and exclusion criteria
The samples are from people with dry mouth with a history of radiation treatment to the head and neck Exclusion criteria: pregnancy/breastfeeding, presence of oral infection or lesion, use of dentures, sensitivity or allergy to ginger/pilocarpine, connective tissue or systemic diseases affecting salivary gland function such as Sjogren's syndrome, rheumatoid arthritis, Lupus and..., history of HIV, hepatitis B and C, blood pressure higher than 90/140 mmHg, cardiovascular diseases, kidney, Parkinson's, asthma, COPD, glaucoma, use of chemical/herbal drugs, alcohol and tobacco compounds Except for cigarettes.
Intervention groups
Group 1: Pilocarpine oral gel 2% Group 2: Ginger oral gel 25%
Main outcome variables
Reduction of dry mouth in sufferers/ relief of dry mouth problems

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240502061625N1
Registration date: 2024-06-15, 1403/03/26
Registration timing: prospective

Last update: 2024-06-15, 1403/03/26
Update count: 0
Registration date
2024-06-15, 1403/03/26
Registrant information
Name
Tayebeh Alipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2213 2234
Email address
alipoorsetareh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-13, 1403/04/23
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral gel pilocarpine 2% and ginger 25% in patients with dry mouth after radiotherapy
Public title
Comparison of the effect of oral gel pilocarpine 2% and ginger 25% in patients with dry mouth after radiotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
dry mouth Head and neck radiotherapy
Exclusion criteria:
alcohol consumption Iodine therapy Systemic diseases affecting the function of salivary glands (sjogren's/rheumatoid arthritis/lupus...) Hypertension Cardiovascular disease Renal disease(Edited)Restore original Parkinson,s Asthma Glaucoma Hepatitis B, C HIV COPD Using chemical/herbal drugs pregnant milking Alhergy to pilocarpine Alhergy to ginger Infection or oral lesions Tissue disorders Denture wearing Use of tobacco compounds other than cigarettes
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 32
More than 1 sample in each individual
Number of samples in each individual: 3
1) Determining the amount of saliva in patients before the intervention on the first day 2) Determining the amount of saliva in patients after the intervention on days 14 and 28
Randomization (investigator's opinion)
Randomized
Randomization description
- In this study, 4 complete random blocks, 2 to A and 2 to B - Randomization unit: person - Randomization tool: Excel software - How to make a random sequence: we put the results in sealed envelopes numbered from 1 to 32, and during the intervention, the envelopes will be opened for the patients in order - The randomization operation is performed by the study methodology consultant, and the researchers do not know the method of intervention of each sample until the time of the intervention, i.e. opening the envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The oral gel of pilocarpine 2% and ginger 25% is prepared by the botanist and packed in 1cc syringes with a colored label, and only the botanist is aware of the contents of the gel, and the patient, clinical caregiver, and researcher do not know about the contents until the end of the study and summary.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran Islamic Azad University of Medical Sciences
Street address
Unit 8 ,No.84 ,East Aseman 4 Ave,Aseman St.,Sadat Abad,Tehran,IRAN
City
Tehran
Province
Tehran
Postal code
1998144988
Approval date
2024-04-22, 1403/02/03
Ethics committee reference number
IR.IAU.DENTAL.REC.1403.012

Health conditions studied

1

Description of health condition studied
xerostomia
ICD-10 code
K11.7
ICD-10 code description
Disturbances of salivary secretion

Primary outcomes

1

Description
amount of saliva
Timepoint
Day 1 before the intervention and days 14 and 28 after the intervention
Method of measurement
Spitting test/sterile test tube

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group (A): ginger oral gel, ginger identified by the botanist of the faculty of pharmacy, whose herbarium code is kept in the herbarium of the faculty, is prepared based on 80% hydroalcoholic extract (80% ethanol) with a concentration of 25% ginger. Also, auxiliary materials that are used to formulate the formulation and modify other characteristics of the formulation such as; taste, appearance, etc. are used include edible grade A gelatin, glycerin to create lubricant effects, peppermint plant essence to create taste, smell and appearance, vitamin C and alpha tocopherol as an antioxidant to increase stability The formulation is used. Gelatin A will be added as a gelling agent, sucrose as a sweetener and other excipients as fillers along with deionized water and thickeners.Medicines are packaged in the form of one milliliter syringes filled with plastic, and the method of use will be specified in the brochure that is delivered and taught to the patients. The day means half a cc every time in the cheek; Use the salivary gland area.In order to compare the changes in the amount of saliva flow on days 1, 14 and 28, the repeated measure ANOVA between subject factor method is used, considering the type of intervention.The samples are selected from among the volunteers (men and women) in the age range of 18-60 years who are literate and have dry mouth and have a history of radiation treatment to the head and neck and 3 months have passed since the completion of the treatment, according to the consultation with the radiotherapy specialist. After selecting the sample and entering the patient into the study and completing the demographic information form (form 1) and dry mouth questionnaire (form 2), the amount of unstimulated saliva is measured using the spitting technique for the patients.The Fox questionnaire is completed by the patient in order to evaluate dry mouth and is self-reported and contains 10 questions with yes/no answers. The questions are designed to measure the signs and symptoms of dry mouth. 4 of these 10 questions are related to the decrease in saliva secretion, which is the main cause of dry mouth. Other questions measure secondary symptoms such as difficulty swallowing and tasting food, nighttime thirst, and mouth burning. The validity and reliability of this questionnaire has been confirmed in various studies. If a person answers 4 or more questions positively, he is considered to have dry mouth.A person's positive answer to 4 questions and above is a sign of real dry mouth. For this purpose, the volunteers are asked to avoid eating, drinking, drinking coffee, smoking, and brushing their teeth at least 2 hours before participating in the study. Wash with 15 ml of distilled water. Then, in a quiet room with sufficient ventilation, rest for 1 minute and sit upright on the dental chair. The researcher asks the patient. Spitting is a simple and non-invasive technique used to measure the amount of saliva. In this method, a person collects his saliva in his mouth and then spits it for five minutes into a sterile polypropylene tube made by KTT ® Company.This method is used as a fast, non-invasive and simple method to measure the amount of saliva. Then, group B volunteers are asked to apply the gel 2 times a day, half a cc each time, locally on the cheek using a swap; Use in the area of ​​salivary glands, which is taught to the patients before starting the study. In addition, the amount of unstimulated saliva will be measured on day 1, 14 and 28 for both groups. Blood pressure, pulse will be measured for patients, and possible drug side effects will be recorded in the relevant information forms on the first day before the start of the study and on days 14 and 28.
Category
Treatment - Drugs

2

Description
The second intervention group (B) 2% pilocarpine gel: 50 grams of pilocarpine from Sina Daru Company was used to prepare 2% pilocarpine gel and added with additives such as edible gelatin, glycerin, mint essence, vitamin C and alpha tocopherol to improve taste, appearance and stability. The formulation is formulated with sucrose and excipients in deionized water. Medicines are packaged in the form of one milliliter syringes filled with plastic, and the method of use will be specified in the brochure that is delivered and taught to the patients. The day means half a cc every time in the cheek; Use the salivary gland area.In order to compare the changes in the amount of saliva flow on days 1, 14 and 28, the repeated measure ANOVA between subject factor method is used, considering the type of intervention.The samples are selected from among the volunteers (men and women) in the age range of 18-60 years who are literate and have dry mouth and have a history of radiation treatment to the head and neck and 3 months have passed since the completion of the treatment, according to the consultation with the radiotherapy specialist. After selecting the sample and entering the patient into the study and completing the demographic information form (form 1) and dry mouth questionnaire (form 2), the amount of unstimulated saliva is measured using the spitting technique for the patients.The Fox questionnaire is completed by the patient in order to evaluate dry mouth and is self-reported and contains 10 questions with yes/no answers. The questions are designed to measure the signs and symptoms of dry mouth. 4 of these 10 questions are related to the decrease in saliva secretion, which is the main cause of dry mouth. Other questions measure secondary symptoms such as difficulty swallowing and tasting food, nighttime thirst, and mouth burning. The validity and reliability of this questionnaire has been confirmed in various studies. If a person answers 4 or more questions positively, he is considered to have dry mouth.A person's positive answer to 4 questions and above is a sign of real dry mouth. For this purpose, the volunteers are asked to avoid eating, drinking, drinking coffee, smoking, and brushing their teeth at least 2 hours before participating in the study. Wash with 15 ml of distilled water. Then, in a quiet room with sufficient ventilation, rest for 1 minute and sit upright on the dental chair. The researcher asks the patient. Spitting is a simple and non-invasive technique used to measure the amount of saliva. In this method, a person collects his saliva in his mouth and then spits it for five minutes into a sterile polypropylene tube made by KTT ® Company.This method is used as a fast, non-invasive and simple method to measure the amount of saliva. Then, group B volunteers are asked to apply the gel 2 times a day, half a cc each time, locally on the cheek using a swap; Use in the area of ​​salivary glands, which is taught to the patients before starting the study. In addition, the amount of unstimulated saliva will be measured on day 1, 14 and 28 for both groups. Blood pressure, pulse will be measured for patients, and possible drug side effects will be recorded in the relevant information forms on the first day before the start of the study and on days 14 and 28.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Azad University of Medical Sciences/Faculty of Dentistry/Bu Ali Hospital
Full name of responsible person
Tayebeh Alipour
Street address
Unit 8 ,No.84 ,East Aseman 4 Ave,Aseman St.,Sadat Abad
City
Tehran
Province
Tehran
Postal code
1998144988
Phone
+98 21 2213 2234
Email
alipoorsetareh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arezoo Alaee
Street address
No.1,9Niastan Ave,pasdaran St
City
Tehran
Province
Tehran
Postal code
12329879540
Phone
+98 21 2256 4571
Email
arezoo.alaee@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tayebeh Alipour
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tayebeh Alipour
Position
ِDental Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Unit 8 ,No.84 ,East Aseman 4 Ave,Aseman St.,Sadat Abad
City
tehran
Province
Tehran
Postal code
1998144988
Phone
+98 21 2213 2234
Email
alipoorsetareh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arezoo Alaee
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No1, 9 Niastan , Pasdaran street
City
Tehran
Province
Tehran
Postal code
12329879540
Phone
+98 21 2256 4571
Email
arezoo.alaee@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tayebeh Alipour
Position
Dental Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Unit 8 ,No.84 ,East Aseman 4 Ave,Aseman St.,Sadat Abad
City
Tehran
Province
Tehran
Postal code
1998144988
Phone
009822132234
Email
alipoorsetareh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
I need advice
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
Not applicable
Data Dictionary
Not applicable
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