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Helping Women Quit Mishri: A New Program vs. the Usual Approach in Maharashtra

Comparison of a Tailormade high intensity with routine Tobacco cessation support program for Indian Women aged 18 45 Years in a district in Maharashtra: -Double-blind parallel armed cluster randomized controlled trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087063
Enrollment
284
Registered
2025-05-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

None listed

Interventions

Intervention1: Tailormade High-Intensity Tobacco Cessation Support Program: Intervention Details: Tailored Tobacco Cessation Program for Women Using Mishri The intervention was a multi-component, high

Sponsors

Kadambari Ambildhok
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women aged 18 to 45 years Current Mishri (smokeless tobacco) users with a minimum daily use for at least the past 6 consecutive months Resident of the selected Primary Health Centre (PHC) area in Pune district, Maharashtra Able to understand and communicate in Marathi or Hindi Willing and able to provide written informed consent

Exclusion criteria

Exclusion criteria: Details: Pregnant or lactating women Women currently enrolled in any other tobacco cessation program Women with severe psychiatric illness or cognitive impairment that may interfere with participation or consent Women unwilling or unable to provide informed written consent

Design outcomes

Primary

MeasureTime frame
Biochemically validated tobacco cessation at 6 months, measured by self-reported abstinence from Mishri use, confirmed using salivary cotinine testingTimepoint: Time Points for Outcome Assessment The primary outcome was assessed at the following time points: Baseline (0 months): To record initial Mishri use status and establish cotinine levels 3 months: Intermediate follow-up to monitor progress and reinforce cessation motivation 6 months: Final follow-up and endpoint, used for determining the primary cessation outcome This timeline allowed the evaluation of both short-term behavioral change and sustained abstinence from Mishri.

Secondary

MeasureTime frame
naTimepoint: na

Countries

India

Contacts

Public ContactDr KADAMBARI AMBILDHOK

Sinhgad Dental College and Hospital

dr.kadambari.phd@gmail.com8378999073

Outcome results

None listed

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