Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT05782166
Eligibility Criteria:
Inclusion Criteria:
1. A self-reported betel quid chewer who has been practising chewing habit for the past 6 months with atleast 2-3 chewing episodes per week. The ingredient of betel quid must include areca nut without or without smokeless tobacco.
2. Other optional ingredients such as inclusion of slaked lime and betel leaf in the betel quid are allowed.
3. Age of participant must be 18 years old and above
4. Participants must be residing in study location (Kota Belud, Sabah)
5. Ability to comprehend, converse and read in Bahasa Melayu and their local language (Bajau)
6. Participants who are able to provide written consent and agree to comply with all protocol-specified procedures such as providing saliva samples, participating in five 1-2 hours sessions of intervention over 22 days and agree to attend follow-up session on the third month
Exclusion Criteria:
1. Non-Malaysian citizen
2. Participants who are not willing to quit the betel quid chewing habit at the time of the study
3. Women chewers who are pregnant or nursing at the time of study
4. Individuals with psychiatric illness or special social situations that would limit their compliance with study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05782166
Study Brief:
Protocol Section:
NCT05782166