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

NCT06268002 | Completed

• 1 other identifier: 5876557033
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation

Keywords

Smoking cessation; Vernonia Cinerea; Non-communicable disease

Outcome Measures

Primary Outcomes (1)

• continuous abstinence rate

  self-report of no cigarette smoking, not even a puff since target quit date, plus passed biochemical validation

  1 month

Secondary Outcomes (1)

• continuous abstinence rate (CAR) and point prevalence rate

  3,6 and 12 months

Study Arms (2)

Vernonia cinerea group

EXPERIMENTAL

1 lozenges 3 times per day

Dietary Supplement: Vernonia cinerea

Placebo group

PLACEBO COMPARATOR

1 placebo lozenges 3 times per day

Dietary Supplement: Placebo

Interventions

Vernonia cinerea DIETARY_SUPPLEMENT

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.

Vernonia cinerea group

Placebo DIETARY_SUPPLEMENT

Sweetener

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Krittin Bunditanukul

Bangkok, 10600, Thailand

Location

MeSH Terms

Conditions

Smoking Cessation; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study was a multicenter randomized, paralleled, double-blind, controlled trial at 5 hospitals and 2 community pharmacies in Thailand

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: September 1, 2017
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: February 28, 2024

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)