A Clinical Trial to compare the effectiveness of herbal hard candy lozenges and Nicotine lozenges to help in tobacco cessation and healing of tobacco related oral lesions.

Development of a novel innovative herbal formulation to reduce tobacco withdrawal symptoms and promote healing of tobacco related oral lesions. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072674

Enrollment

Registered

2024-08-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: F172- Nicotine dependence

Interventions

Intervention1: Herbal hard candy lozenges consisting of Tulsi leaves extract 50 mg, Turmeric extract 50 mg, Oats extract 37.5 mg, and Guava leaves extract 25 mg.: The lozenges will be administered 3

Eligibility

Inclusion criteria

Inclusion criteria: Patients in the age group of 18 to 65 years with a history of tobacco use both smoking and smokeless forms of tobacco. History of tobacco use for at least 6 months. Tobacco users with related non malignant oral lesions. Willingness to reduce daily use of tobacco based on Richmond test. Patients willing to give informed consent. Fagerstrom test for Nicotine dependence score of 4 points and more.

Exclusion criteria

Exclusion criteria: Patients on antidepressant or antipsychotic medication. Patients with known allergy to any of the herbs used in the formulation. Patients using any other medication for tobacco or alcohol dependence.

Design outcomes

Primary

Measure	Time frame
The efficacy of the intervention in reducing the tobacco withdrawal symptoms will be assessed using the Minnesota Tobacco Withdrawal Scale and the tobacco dependence will be assessed using Fagerstrom Test for Nicotine Dependence. Complete abstinence and partial reduction in tobacco use will be assessed. To determine the healing of tobacco related oral lesions three-point rating scale for pain and size of the lesion in millimeters will be recorded.Timepoint: At baseline, at the end of each month for a period of 3 months.	—

Measure

Time frame

The efficacy of the intervention in reducing the tobacco withdrawal symptoms will be assessed using the Minnesota Tobacco Withdrawal Scale and the tobacco dependence will be assessed using Fagerstrom Test for Nicotine Dependence. Complete abstinence and partial reduction in tobacco use will be assessed. To determine the healing of tobacco related oral lesions three-point rating scale for pain and size of the lesion in millimeters will be recorded.Timepoint: At baseline, at the end of each month for a period of 3 months.

—

Secondary

Measure	Time frame
Salivary Cotinine tests will be done to confirm a reduction in tobacco use.Timepoint: At baseline and at the end of 3 months.	—

Countries

India

Contacts

Public ContactDr Nishath Khanum

JSS Dental College and Hospital

drchandrashekarbr_dch@jssuni.edu.in8197705773

Outcome results

None listed

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