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CTRI Number  CTRI/2025/10/095609 [Registered on: 06/10/2025] Trial Registered Prospectively
Last Modified On: 04/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Efficacy of an Ayurvedic herbal lozenge for nicotine withdrawal  
Scientific Title of Study   Efficacy of an Ayurvedic herbal lozenge for nicotine withdrawal – A Preclinical and Pilot clinical study for tobacco cessation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sree Lakshmi J 
Designation  PG Scholar 
Affiliation  All India Institute of Ayurveda 
Address  Room number 622(Seminar hall), 6th floor Academic block, Department of Swasthavritta All India Institute of Ayurveda Gauthampuri Awas, Sarita Vihar, New Delhi South Delhi 110076

South
DELHI
110076
India 
Phone  8248059649  
Fax    
Email  sreejanarthanan1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shivakumar S Harti 
Designation  Additional professor, HOD , Department of Swasthavritta 
Affiliation  All India Institute of Ayurveda 
Address  Room number 602, 6th floor Department of Swasthavritta Academic block All India Institute of Ayurveda Gauthampuri Awas, Sarita Vihar, New Delhi

South
DELHI
110076
India 
Phone  9611275434  
Fax    
Email  shivakumarsharti@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shivakumar S Harti 
Designation  Additional professor, HOD , Department of Swasthavritta 
Affiliation  All India Institute of Ayurveda 
Address  Room number 602, 6th floor, Department of Swasthavritta Academic block All India Institute of Ayurveda Gauthampuri Awas, Sarita Vihar, New Delhi

South
DELHI
110076
India 
Phone  9611275434  
Fax    
Email  shivakumarsharti@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda Gauthampuri Awas, Sarita Vihar, New Delhi South Delhi 110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  All India Institute of Ayurveda Gauthampuri Awas, Sarita Vihar, New Delhi, South Delhi 110076 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sree Lakshmi J  All India Institute of Ayurveda  Screeing OPD,OPD number 8 B, 5, 7 Room no. 622, 6th floor, Academic block All India Institute of Ayurveda Gauthampuri Awas, Sarita Vihar, New Delhi South Delhi 110076
South
DELHI 		 8248059649

sreejanarthanan1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Participants who are tobacco users (smokers) intending to quit. 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Ayurvedic herbal Lozenge, Reference: NA, Route: Oral, Dosage Form: Lozenges, Dose: 4(mg), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Maximum of 6 lozenges of 4 mg per day
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Male and female participants having a history of smoking a minimum of 5 cigarettes daily.
2. Willing to quit (assessed by RCQ greater than 5) and provide written consent for intervention and follow-up of 45 days in the study. 
 
ExclusionCriteria 
Details  1. Participants with major illness.
2. Those having associated addiction or substance abuse, and smokeless tobacco users.
3. Uncontrolled hypertension(greater than 160 mmHg) or diabetes.
4. Pregnant and lactating women.
5. Any significant psychiatric illness or mood disorders.
6. Those taking any anti-smoking medication or nicotine replacement therapy(NRT) in the previous month.
7. Those who are taking any other medications interfering with the treatment protocol.
8. Those with known hypersentivity to any ingredients of the study drug.
9. Those who are not willing to participate.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Decrease in severity and frequency of withdrawal symptoms assessed by POMS (Profile of Mood State) and questionnaire using the Likert scale.   Intervention period - 1 month
Follow up - 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in smoking (number of cigars taken per day) assessed using the Fagerstrom Test for Nicotine Dependence (FTND) scale.  Intervention period - 1 month
follow up - 15 days 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study aims to evaluate the efficacy of an Ayurvedic herbal lozenge in managing nicotine withdrawal and supporting tobacco cessation. Tobacco use is a major global health problem, responsible for millions of deaths annually, and current pharmacological options for de-addiction have limitations.

Ayurvedic texts describe concepts like Dushi Visha (chronic toxins) and Dhumopahat (smoke-induced disorders), which parallel the modern understanding of long-term tobacco toxicity. Based on classical references and contemporary evidence, a novel herbal lozenge formulation has been developed, containing herbs with dopaminergic, nootropic, antioxidant, and mucosal-soothing properties.

The research will be conducted in two phases:

  1. Preclinical phase – assessing safety and preliminary efficacy in animal models.

  2. Pilot clinical study – testing the lozenge in human participants with tobacco dependence, focusing on withdrawal symptoms, craving reduction, and safety.

The expected outcome is to generate preliminary scientific evidence supporting the use of an Ayurvedic herbal lozenge as a safe, effective, and integrative option for tobacco cessation, paving the way for larger controlled clinical trials.

 
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