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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Dietary supplement: Vernonia cinerea; Dietary supplement: 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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10600
    • Krittin Bunditanukul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 (defined as no asthmatic exacerbation for the preceding 4 weeks necessitating oral prednisolone or an increased use of inhaled corticosteroid, the use of rescue treatment no more than three times a week, and with no clinical indication for change in treatment medication) 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vernonia cinerea group; 1 lozenges 3 times per day	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.
Placebo Comparator: Placebo group; 1 placebo lozenges 3 times per day	Dietary supplement: Placebo; Sweetener

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
continuous abstinence rate	self-report of no cigarette smoking, not even a puff since target quit date, plus passed biochemical validation	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
continuous abstinence rate (CAR) and point prevalence rate	self-report of no cigarette smoking, not even a puff since target quit date, plus passed biochemical validation	3,6 and 12 months

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Smoking cessation; Non-communicable disease; Vernonia Cinerea
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Noncommunicable Diseases
• Other Study ID Numbers: 5876557033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No