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Evaluation of the effect of an artificial saliva produced from aqueous extract of Okra ( Abelmoschus Esculentus) on the xerostomia symptoms in diabetic patients

Protocol summary

Study aim
To determine the effect of artificial saliva derived from aqueous extract of okra (Abelmoschus Esculentus) on symptoms of dry mouth in diabetic patients.
Design
A controlled, parallel-group, double-blind, block-based randomized, clinical trial, phase 3, on 80 patients
Settings and conduct
In Birjand Dental School, 80 patients who meet the inclusion criteria will participate in the study with their consent. They will be randomly divided into two groups, complete the Persian version of the Fox questionnaire, receive different combinations, and to investigate the effect of these combinations in different groups after the end of the intervention (day 15 of the study), the Persian version of the Fox questionnaire will be used to determine the effect of the interventions on dry mouth. Blinding: Using identical coded packaging. Blinded individuals: researcher, patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range 18-65 years; dry mouth based on completion of the Fox questionnaire with a positive answer (yes) to at least 4 questions of the questionnaire; diabetes based on the criteria for diagnosing diabetes. Exclusion criteria: Pregnancy; use of saliva-reducing drugs, using other artificial saliva products; history of autoimmune disorders; pneumonia; presence of oral or perioral lesions; sensitivity to okra, death; development of oral and perioral lesions; decision of the individual or their legal guardian to withdraw from the study.
Intervention groups
(Case group): People in this group included 40 patients, using aqueous extract of okra fruit 3 times a day for two weeks (Positive control group): People in this group included 40 patients, using carboxymethyl cellulose solution 3 times a day for two weeks
Main outcome variables
The score obtained in the Fox questionnaire is measured before the start of the intervention and after the end of the intervention on the 15th day

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250311065040N1
Registration date: 2025-04-22, 1404/02/02
Registration timing: prospective

Last update: 2025-04-22, 1404/02/02
Update count: 0
Registration date
2025-04-22, 1404/02/02
Registrant information
Name
Hossein Shirmehenji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3246 9257
Email address
h.shirmehenji@bums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-05-05, 1404/02/15
Expected recruitment end date
2025-12-06, 1404/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of an artificial saliva produced from aqueous extract of Okra ( Abelmoschus Esculentus) on the xerostomia symptoms in diabetic patients
Public title
Evaluation of the effect of an artificial saliva produced from aqueous extract of Okra ( Abelmoschus Esculentus) on the xerostomia symptoms in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be between the ages of 18 and 65 years old Patients must have dry mouth, based on the Fox questionnaire with at least a positive response to 4 of the 9 questions on the questionnaire Diabetes based on diabetes diagnosis criteria
Exclusion criteria:
Pregnancy Taking medications that reduce salivation Use of other artificial saliva products History of autoimmune diseases History of pneumonia Presence of oral or perioral lesions
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups 1 (intervention) and 2 (control) using a block randomization method, for this purpose, blocks of four are formed including A, B. (For example: AABB, BABA, ABAB) Then, until the sample is completed, the blocks are selected by simple random selection. Also, A will be the intervention group (artificial saliva containing aqueous extract of okra) and B will be the control group (artificial saliva containing carboxymethyl cellulose).
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants and the principal investigator (student performing the intervention and collecting the data) will be blinded by packaging the artificial saliva in the same way and not being aware of the assignment of individuals to the study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghafari
City
Birjand
Province
South Khorasan
Postal code
91717853076
Approval date
2025-03-15, 1403/12/25
Ethics committee reference number
IR.BUMS.REC.1403.469

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
Score obtained on the Fox questionnaire
Timepoint
Days 0 and 14 of the study
Method of measurement
Fox Dry Mouth Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: People in this group, including 40 patients, will rinse their mouths with 2 ml of aqueous extract of okra fruit (30 g sorbitol, 11.7 g aqueous extract of okra, 804 mg dipotassium mono hydrogen phosphate, 625 mg potassium chloride, 366 mg potassium dihydrogen phosphate, 166 mg calcium chloride, 59 mg magnesium chloride, and sodium benzoate at a rate of 0.05% of the total solution as a preservative in 1000 g distilled water) 3 times a day for 2 weeks.
Category
Treatment - Drugs

2

Description
Control group: People in this group, including 40 patients, will rinse their mouths with 2 ml of carboxymethylcellulose solution with the formula (30 g sorbitol, 11.7 g carboxymethylcellulose, 804 mg dipotassium mono hydrogen phosphate, 625 mg potassium chloride, 366 mg potassium dihydrogen phosphate, 166 mg calcium chloride, 59 mg magnesium chloride and sodium benzoate at a rate of 0.05% of the total solution as a preservative in 1000 g distilled water) 3 times a day for 2 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic, Vali-Asr Hospital, Birjand
Full name of responsible person
Dr. Hossein Dehghani
Street address
South Khorasan, Birjand, Ghaffari Street, Vali Asr Educational and Medical Center
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3162 2001
Fax
+98 56 3204 1088
Email
valiasr@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Masoud Yousefi
Street address
South Khorasan, Birjand , Ghafari Street, Birjand University of Medical Sciences, Education and Research Building - Second Floor - Research and Technology Office
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Fax
+98 56 3238 1220
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Hossein Shirmehenji
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Birjand Dental School, Corner of Pasdaran 3, Pasdaran Blvd.
City
Birjand
Province
South Khorasan
Postal code
1713643135
Phone
+98 56 3238 1700
Email
h.shirmehenji@bums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Parvin Parvaie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Birjand Dental School, Corner of Pasdaran 3, Pasdaran Blvd.
City
Birjand
Province
South Khorasan
Postal code
1713643135
Phone
+98 56 3238 1700
Email
parvin.parvaie@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hossein Shirmehenji
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Birjand Dental School, Corner of Pasdaran 3, Pasdaran Blvd.
City
Birjand
Province
South Khorasan
Postal code
1713643135
Phone
+98 56 3238 1700
Fax
Email
h.shirmehenji@bums.ac.ir

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
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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