Abstract
Background Smokeless tobacco (SLT) poses a major public health risk, linked to cancer, heart disease, and stroke. Nicotine Replacement Therapy (NRT) is commonly used for tobacco cessation. However, it carries a high risk of relapse, which significantly limits its long-term effectiveness. Nicotine free Ayurvedic formulations (NFAF), having potential anti-stress and mood enhancing properties may offer a healthier promising alternative.
Purpose The study evaluated the efficacy and safety of the proposed Nicotine free Ayurvedic formulation compared to NRT in tobacco chewers.
Methods A two-arm, open-label, randomized, multicentric clinical trial involving 112 participants was conducted with one group receiving NFAF and the other NRT for 90 days with follow ups every 15 days till day 90 and a follow up on day 120 after 30 days of non intervention. Parameters such as frequency, duration of tobacco/gutka usage to evaluate dependency on nicotine, mouth opening capacity, quality of life, physiological measures and clinical symptoms were assessed. Safety assessment was also done based on clinical and laboratory parameters.
Results The proposed Nicotine free Ayurvedic formulation was observed to be as effective as NRT in reducing tobacco consumption and dependence. Significant and comparable reduction in stress, fatigue and improvement in energy strength, stamina and well-being were observed with the use of NFAF. Clinical symptoms such as headache, fatigue, and mood changes improved similarly in both groups. A higher percentage of NFAF users (21.56%) achieved complete cessation of tobacco consumption versus NRT users (17.77%). NFAF was observed to be well tolerated, with only minor, self-limiting adverse events.
Conclusion NFAF effectively reduced SLT dependence and improved quality of life and clinical symptoms, with good safety. It represents a healthier alternative for tobacco cessation.
Competing Interest Statement
The authors have declared no competing interest.
Clinical Trial
CTRI/2023/07/055111
Funding Statement
This study was funded by Gurseet Singh, Smotect Pvt. Ltd.
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Study was conducted after approval from the Institutional Ethical Committees of the respective study sites-
KVTR Ayurved College and Hospital - AMB/516/2023-24
Parul Institute of Ayurveda & Research - PAIR/IEC/04/2023
Seth Govindji Raoji Ayurved Mahavidyalaya - IEC/LTR/SGR/04/2023-24
Ayurved Seva Sangh Ayurvedic College & Hospital - 646
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Footnotes
Contact details: +91 9322522252, Email – sanjaytamolihotmail.com
Contact details: 020 24378088, Email – dr.vaishalidgmail.com
Contact details: 0253 2513112, Email – shishir.nskgmail.com
Contact details:+91 9850378206, Email – drnbmundhegmail.com
Contact details:+91 9422957234, Email – santoshswami2009gmail.com
Contact details:+91 9482249665, Email – eshwari.salianparuluniversity.ac.in
Contact details:+91 9881922218, Email – kamaleshmahajan2012gmail.com
Contact details:+91 9404582991, Email – sandipbirarigmail.com
Contact details:+91 9322522252, Email – shrutitarapuregmail.com
Contact details: +91 8975533215, Email – drrubydubeygmail.com
Contact details: +91 9867416430, Email – ninadmulyegmail.com
Contact details: +91 9820077161 Email – gurseetsmotect.com
Data Availability
All data produced in the present study are available upon reasonable request to the authors
Comments (0)