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Evaluation of the effects of Pilocarpine gum on saliva secretion

Preparation of Pilocarpine gum formulation and its effect on saliva secretion

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191106045356N19
Enrollment
40
Registered
2023-08-29
Start date
2023-08-19
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry mouth caused by Sjogren's syndrome. Sicca syndrome [Sjogren]

Interventions

Intervention 1: Intervention group: includes 20 people with Sjogren's syndrome who meet the criteria for entering the study, and their order and type of intervention are randomized based on the (RND)

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Willingness to participate in the study and complete the ethical consent form Patients with Sjogren's syndrome under standard treatment

Exclusion criteria

Exclusion criteria: Irritation or allergic reaction to the drug Absence of specific systemic disease Absence of sores and inflammation or infection in the mouth and throat Not taking Pilocarpine or Cevimeline in the week before the test No glaucoma No respiratory disease such as asthma

Design outcomes

Primary

MeasureTime frame
The amount of saliva secretion. Timepoint: Measuring the volume of saliva secreted at the beginning of the study (before the start of the intervention) and after taking the first dose on the first day and the last dose on the third day. Method of measurement: Changing the weight of the dental cotton roll by absorbing the saliva secreted in the mouth.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Zabihi

Yazd University of Medical Sciences

mzabihi100@gmail.com+98 35 3820 3865

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026