Effect of Vernonia cinerea lozenges as a smoking cessation aid in patients with non-communicable diseases

Phase 3

Completed

• Conditions: on-communicable disease patients who are active smoking; Vernonia Cinerea lozenge; non-communicable diseases; Smoking cessation

• Registration Number: TCTR20180823002
• Lead Sponsor: TOBACCO CONTROL RESEARCH AND KNOWLEDGE MANAGEMENT CENTER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-23
• Study Completion: 2021-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

Age at least 18 years old
- Have at least 1 underlying non-communicable disease include hypertension, diabetes, dyslipidemia, cardiovascular diseases, cerebrovascular diseases, stable asthma, COPD stage A-C according to GOLD guideline, chronic kidney diseases
- Smoke 10 cigarettes or over per day at least 1 month prior to study
- Desired to quit smoking
- Consent to participate in study

Exclusion Criteria

- Renal dysfunction (GFR < 30 ml/mins/1.73m2)
- Liver dysfunction (Child-Pugh score C)
- Hyperkalemia (serum potassium <=5 mEq/L)
- Documented of active depression or psychosis
- Active cancer
- History of acute coronary syndrome in previous 4 weeks
- Known case of pregnancy or lactation
- Use other tobacco products or other addictive substances except alcohol
- Use other smoking cessation drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
continuous abstinence rate 1 and 3 months after quit date Stop smoking is defined by self-reported on smoking cessation plus exhaled CO measurement

Secondary Outcome Measures

Name	Time	Method
continuous abstinence rate (CAR) and point prevalence rate (PAR) 1,3, 6 and 12 months Stop smoking is defined by self-reported on smoking cessation plus exhaled CO measurement