None listed
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Vinod P
Eligibility
Inclusion criteria
Inclusion criteria: Male and female participants between 18 to 70 years of age (both inclusive) Participants who smokes greater than or equal to 10 cigarettes per day for greater than or equal to 5 years. Participants with an exhaled carbon monoxide (eCO) concentration of greater than or equal to 7 ppm. Participants must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits. Willingness to provide written informed consent to participate in the study. Female Participants with negative pregnancy test during screening and enrollment
Exclusion criteria
Exclusion criteria: Personal / family history or presence of allergy or hypersensitivity to Inhalers (with essential oil of peppermint/black pepper). Suffering from any major illnesses, uncontrolled hypertension and diabetes, hepatic or renal impairment, central nervous system disorders and known hypersensitivity to any ingredient of the study drug. Participants who are on active NRT/cessation medications. Participants with presence of any chronic respiratory disorders and with history of lung conditions (eg. Asthma, COPD or bronchial). Female participants are currently breast-feeding. Consumption of alcohol within 48 hours prior to study enrolment. Known or suspected increased susceptibility to infection. History of use of recreational drug or a history of drug addiction. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of Liver Function Test (LFT), Renal (kidney) Function Test (RFT), etc. Any major illness in the past three months or any clinically significant on-going chronic medical illness e.g., congestive heart failure, hepatitis, pancreatitis etc. Presence of disease markers of HIV 1 and 2 and hepatitis B and C virus. History or presence of significant easy bruising or bleeding. Participant who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Quitci Flow with essential oil fuds of peppermint/black pepper flavour in smokers by assessing below mentioned parameters. Immediate craving relief after use. Reduction of cigarettes/day from baseline to Day 7, Day 14 and Day 30. Quit rate at Day 7, Day 14 and Day 30. Timepoint: Immediate craving relief after use. Reduction of cigarettes/day from baseline to Day 7, Day 14 and Day 30. Quit rate at Day 7, Day 14 and Day 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety/tolerability and basic usability/acceptabilityTimepoint: not applicable | — |
Countries
India
Contacts
Public ContactDr N Srikanth MBBS
AnaCipher Clinical Research Organization
Outcome results
None listed