Study on the Effectiveness of Modified Tambul Churna in Reducing Chewing Tobacco Use – A Single-Arm Clinical Trial

Phase 3

Not yet recruiting

• Conditions: Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified. Ayurveda Condition: DUSHIVISHOPADRAVAH,

• Registration Number: CTRI/2025/04/084290
• Lead Sponsor: Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha

Brief Summary

The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-30
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Paricipants of either gender between age of 18 to 40 years willing to get de-addicted.
• Paricipants suffering from tobacco product consumption , who will be ready to participate in the study and willing to give written consent.

Exclusion Criteria

• Participants is not willing.
• Participants with oral pathology like(stomatitis oral cancer submucosal fibrosis).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to evaluate the efficacy of a modified Tambul Churna formulation in minimizing the frequency of chewing tobacco products in habitual users	Three Months

Secondary Outcome Measures

Name	Time	Method
Decline in craving intensity among participants. Improvements in urine cotinine levels were observed indicating potential detoxification benefits	Three Months

Trial Locations

Locations (1)

Mahatma Gandhi Ayurved College Salod Wardha; 🇮🇳 Wardha, MAHARASHTRA, India

Mahatma Gandhi Ayurved College Salod Wardha

🇮🇳Wardha, MAHARASHTRA, India

Dr Sumit Dhote

Principal investigator

09370607518

sumitdhote12@gmail.com