None listed
Conditions
Interventions
Intervention1: This study is conducted to assess the Effectiveness of the Herbal Sticks on tobacco smoking cessation: This study will be conducted over 28 days spanning over 3 visits to the trial site
Sponsors
EnergyStick India Limited
Eligibility
Inclusion criteria
Inclusion criteria: â?? Willingness to give written informed consent â?? Male and female in the age group of 21- 60 years. â?? Persons who described themselves as current smokers and smoke more than 4 bid is or cigarettes /day. â?? Motivated to quit smoking. â?? According to Fagerstrom Questionnaire subjects with score of 6 or more which indicate moderate to high dependence will be selected. â?? Only one member from a family will be included in the study. â?? Willingness to stop all other cigarettes â?? Willingness to follow the protocol requirements as evidenced by written informed consent. â?? Comprehension of the nature and purpose of the study and compliance with the requirement of the entire procedure
Exclusion criteria
Exclusion criteria: â?? Healthy Volunteers below the age of 21 years and above the age of 60 years. â?? Healthy Volunteers who is not willing to participate in the study â?? Serious or unstable cardiac, renal, hypertensive, pulmonary, endocrine or neurologic disorders â?? A current diagnosis of major depressive episode or a history of panic disorder. â?? Psychosis, bipolar disorder, eating disorder, use of nicotine replacement therapy within six months before study enrollment. â?? Abuse of alcohol or a non nicotine containing drug within the preceding year. â?? Prior use of Bupropion. â?? Current use of NRT with smoking. â?? Regular use of any non cigarette tobacco product. â?? Family history of seizures. â?? History of severe head trauma. â?? Participant who is under guardianship, or unable to understand the information (for linguistic or mental reason), or unwilling to give her/his informed consent to participate in the study. â?? A female volunteer who is breast-feeding, pregnant, or intends to become pregnant during the study â?? Participating in a clinical research trial within 30 days prior to screening â?? Individuals who are cognitively impaired and/or who are unable to give informed consent. â?? Any other health or mental condition that in the Investigatorâ??s opinion may adversely affect the volunteerâ??s ability to complete the study or its measures or that may pose significant risk to the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effectiveness of the Herbal Sticks on tobacco smoking cessationTimepoint: Improvement in comparison to baseline, determined by Cigarette Dependence Scale (CDS) Assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Herbal Sticks to cope nicotine withdrawal symptoms experienced during smoking cessation To evaluate effect of Herbal Sticks on Cotinine level in body between baseline and end of study To evaluate safety of Herbal Sticks Timepoint: Comparison of NDSS from baseline to end of treatment Comparison of NDSS from baseline to end of study Comparison of Cotinine level from baseline to end of treatment To assess the Total number of Treatment Emerged AE ( TEAE) through response for Nicotine Withdrawal Symptom Assessment. | — |
Countries
India
Contacts
Public ContactMr Sundar Ganesh
iDD Research Solutions Pvt. Ltd
Outcome results
None listed