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临床试验/NCT01896375
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Impact of 'Gutkha and Pan Masala Ban' in the State of Maharashtra on Users and Vendors

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
1
主要终点
Gutkha or Pan Masala Habit Quit

研究概览

简要总结

Present study is conducted on Gutkha and Pan Masala users to find out the impact of ban on them. It will also try to find out awareness about ban and source of information for the same. Availability of Gutkha and Pan Masala in post ban period will also be assessed.

详细描述

Background: Based on the various reports indicating health hazards of gutka and pan masala there are various efforts to ban the production, consumption, sale, storage and transportation of these products by various states in India. The situation had gone to such an extent that government had no other option than to ban these products. In India gutka is classed as a food item and falls within the purview of Prevention of Food Adulteration act. The Central Committee on Food Standards (CCFS) had already reported a complete ban to the Central Government a decade ago itself. The reasons unanimously given by CCFS for a complete ban on Gutka were 1) Children are getting addicted to these products in large numbers; 2) Users develop Oral Submucous Fibrosis and cancer over a relatively shorter duration and die earlier compared to smokers; 3) Women prefer smokeless tobacco due to social disapproval of their smoking and therefore may be particularly vulnerable to gutka addiction. Tamil Nadu had banned Gutka in 2001 itself. Andhra Pradesh, Goa, Maharashtra & Rajasthan had also followed the same in August 2002.4 Subsequently following some legal battles ban on Gutka in Maharashtra was lifted. But now following the example of eight other states in India, Government of Maharashtra has finally banned the manufacture, storage, distribution or sale of Gutka and Pan masala, containing either tobacco and/or nicotine or Magnesium Carbonate as ingredients by whatsoever name these are available in the market and any other products marketed separately to constitute as Gutka and Pan Masala, etc. as final products from July 19, 2012.8 The appeal filed by some manufacturers in Bombay High Court has been quashed and the ban is to continue now unless it is reversed by the Supreme Court of India. Sensing the possibility of Supreme Court (SC) appeal by gutka and pan masala manufacturers the Government of Maharashtra has already filed an caveat there so that there plea will be heard first by SC before passing any order in this matter.

There is a large population addicted to Gutkha and pan-masala all over India. We would like to study the impact of this ban on the users of this product and on the tobacco vendors. Even if the ban is reversed by the Supreme Court, we would still like to study its impact in the interim period when the ban was imposed.

Rationale: Seeing the addictive potential of the contents of gutka and pan masala, it will be interesting to record the effect of ban of these products on the regular consumers. Whether they have stopped the consumption or are still getting the products (by smuggled routes) is an important issue. If they have shifted to other tobacco products, it will be important to study the shift pattern. If at all some withdrawal symptoms are reported by them, it will be helpful to record it so as to devise our cessation strategies. If the previous regular consumers have stopped the consumption of gutka and pan masala because of ban, it is positive sign in support of legal ban for the maintenance of proper public health. The response of gutka and pan masala users to the ban has to be studied. To what extent they have accepted the ban and what reaction they are giving are important issues to be studied. In depth analysis of all these points will be helpful in the development of further public health strategy as far as use of gutka and pan masala is concerned.

The second aspect of this study is to investigate the response and implications of tobacco vendors to the ban. In last few years there was tremendous increase in vendors of tobacco especially Gutka and Pan-masala. These products being cheaply available were marketed in almost all corners of cities and villages. Even public transport vehicle were also flooded by the presence of many street vendors. Ultimately all these vendors were working as the merchants of deadly tobacco products. So the study of the response of these people to ban is an issue of interest. The implication of the ban on them if studied in depth can help us to devise some strategy for their rehabilitation and preventive programmes to deter them from indulging into such type of business. We may also get some newer insights to strengthen the ban.

Aim and Objectives:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For survey : All tobacco users
  • Part I-All the persons (≥ 18 years) using gutkha and/or pan masala (at the time of implementation of ban) in the selected community.
  • Part-II All tobacco vendors (≥ 18 years) in the selected locality

排除标准

  • Those dead, shifted out of the area, unwilling to give consent and severely ill

结局指标

主要结局

Gutkha or Pan Masala Habit Quit

时间窗: After 3 months

The person who has quit consuming Gutkha / Pan Masala (has not consumed it at least for a month) after 3 months will be considered as quitter of the habit.

次要结局

  • Decrease in consumption of Gutkha and / or Pan Masala(After 3 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gauravi Ashish Mishra

Associate Professor

Tata Memorial Hospital

研究点 (1)

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