NCT06268002

Effect of Vernonia Cinerea Lozenges as a Smoking Cessation Aid in Patients With Non-communicable Diseases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Vernonia cinerea is an herbal which has been recorded in many Thai herbal formulation and Thai traditional medicine has used this herbal for treating various diseases included hypertension, asthma, fever, hepatitis, kidney stone and smoking cessation. Now aday there are more interest for using Vernonia cinerea as a medication to aid smoker to quit smoking because it is cheaper than other current therapeutic medications. The objective of this study is to evaluate efficacy and safety of Vernonia cinerea lozenge for smoking cessation when compared to placebo.

Detailed description

This study is a multicenter randomized, paralleled, double blind, controlled trial. This study will include 260 patients from Lerdsin hospital, Chest institute, Phramongkutklao hospital, Maharaj Nakorn Chiang Mai Hospital and Paolo Memorial Phaholyothin hospital who would like to quit smoke. Patients will be assigned into two groups, Vernonia cinerea group (n=130) and placebo group (n=130), both groups will be instructed to take one lozenge three times a day for three months. The two groups will receive individual counseling about smoking cessation technique by trained healthcare professional on every visit. The main primary outcome for this study is continuous abstinence rate (CAR), define as self-report of no cigarette smoking, not even a puff since target quit date, plus passed biochemical validation for 1 month.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vernonia cinerea	Vernonia cinerea is an herb that is claimed in many Thai medicinal formulas. In traditional medicines, they use this herbal to treat diseases such as hypertension, asthma, fever, hepatitis, gallstones, including use to help smoker quit smoking.
DIETARY_SUPPLEMENT	Placebo	Sweetener

Timeline

• Start date: 2017-09-01
• Primary completion: 2021-09-30
• Completion: 2021-12-31
• First posted: 2024-02-20
• Last updated: 2024-02-28

Locations

1 site across 1 country: Thailand