Smoking CessationNCT06268002
Effect of Vernonia Cinerea Lozenges as a Smoking Cessation Aid in Patients With Non-communicable Diseases
A study testing Vernonia cinerea in people with Smoking Cessation, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Vernonia cinerea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Known case of pregnancy or lactation
- Use other tobacco products or other addictive substances except alcohol
- Use other smoking cessation drugs
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Vernonia cinerea, Placebo
- Keywords
- Smoking cessation, Vernonia Cinerea, Non-communicable disease
- Medical subject headings
- Smoking Cessation, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vernonia cinereaDietary 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.
PlaceboDietary supplement
Sweetener
| Study group | Role | What they receive |
|---|---|---|
| Vernonia cinerea group | Experimental | 1 lozenges 3 times per day Receives: Dietary Supplement: Vernonia cinerea |
| Placebo group | Placebo comparator | 1 placebo lozenges 3 times per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
continuous abstinence rate
self-report of no cigarette smoking, not even a puff since target quit date, plus passed biochemical validation
Measured: 1 month
Secondary outcomes (1)
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
Measured: 3,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Sep 2017
- Primary completion30 Sep 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was a multicenter randomized, paralleled, double-blind, controlled trial at 5 hospitals and 2 community pharmacies in Thailand
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268002
- Sponsor's protocol ID
- 5876557033
- Status last verified
- Jan 2018
- First submitted
- 12 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vernonia Cinerea Lozenges as a Smoking Cessation Aid in Patients With Non-communicable Diseases
- ClinicalTrials.gov ID
- NCT06268002
- Acronym / sponsor ID
- 5876557033
- Conditions
- Smoking Cessation
- Keywords
- Smoking cessation, Vernonia Cinerea, Non-communicable disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study was a multicenter randomized, paralleled, double-blind, controlled trial at 5 hospitals and 2 community pharmacies in Thailand
| Arm | Type | Receives |
|---|---|---|
| Vernonia cinerea group | Experimental | Dietary Supplement: Vernonia cinerea1 lozenges 3 times per day |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo1 placebo lozenges 3 times per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vernonia cinereaVernonia 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 | Vernonia cinerea group |
| PlaceboSweetener | Dietary supplement | Placebo group |
Primary outcome
continuous abstinence rate
Time frame: 1 month
self-report of no cigarette smoking, not even a puff since target quit date, plus passed biochemical validation
1 secondary outcome
continuous abstinence rate (CAR) and point prevalence rate
Time frame: 3,6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vernonia cinerea in people with Smoking Cessation, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
continuous abstinence rate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.