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Efficacy of an Ayurvedic herbal lozenge for nicotine withdrawal

Efficacy of an Ayurvedic herbal lozenge for nicotine withdrawal A Preclinical and Pilot clinical study for tobacco cessation - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/095609
Enrollment
15
Registered
2025-10-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

All India Institute of Ayurveda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Decrease in severity and frequency of withdrawal symptoms assessed by POMS (Profile of Mood State) and questionnaire using the Likert scale.Timepoint: Intervention period - 1 month Follow up - 15 days

Secondary

MeasureTime frame
Reduction in smoking (number of cigars taken per day) assessed using the Fagerstrom Test for Nicotine Dependence (FTND) scale.Timepoint: Intervention period - 1 month follow up - 15 days

Countries

India

Contacts

Public ContactShivakumar S Harti

All India Institute of Ayurveda

shivakumarsharti@gmail.com9611275434

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026