Clinical study to evaluate efficacy and safety of Smotect Azaadi Rich Granules for its effect on nicotine (tobacco) de-addition in gutka users
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in nicotine (chewable tobacco) addiction (average amount of gutka consumed between study visits and number of days required for reduction or complete cessation)
研究概览
简要总结
It is a clinical study to evaluate efficacy and safety of Smotect Azaadi Rich Granules for its effect on nicotine (tobacco) de-addition in gutka users. The study will be carried out in one to two centers in India. Subjects will be asked to consume Smotect Azaadi Rich Granules as and when required (having urge to chew tobacco). Subjects will be asked to use not more than 6 pouches (not more than one at a time) daily for 30 days. The primary objective of the study will be to assess change in nicotine (chewable tobacco) addiction (average amount of gutka consumed between study visits and number of days required for reduction or complete cessation). The secondary objectives of the study will be to assess quality of life (QOL) on WHO QOL Questionnaire, level of Energy, level of stamina and physical strength on a 7- point scale, level of stress using VAS, change in daytime fatigue on VAS, clinical symptoms related to chewable tobacco or gutka, oral health (mouth opening capacity) and mouth ulcers, global evaluation for overall change on CGI-I Scale as per physician and subjects, adverse events and change in global assessment of overall safety of study drug as per the physician and subjects on screening visit (Day -3), Baseline visit (Day 0), Visit 1 (day 15), and Visit 2 (Day 30)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects consuming a minimum of 4 packets (approx.
- •10 gm) gutka daily for more than 5 years
- •Subjects not suffering from any significant illness (medical or surgical)
- •Subjects of female gender or non-pregnant, non-lactating females.
- •A urine pregnancy test is required for all female subjects of childbearing potential unless female subject has had a hysterectomy, tubal ligation, or is greater than or equal 2 years postmenopausal.
- •Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
排除标准
- •Known cases of Severe or Chronic disease
- •Known subject of any active malignancy.
- •Subjects giving history of significant cardiovascular event less than or equal to 12 weeks prior to randomization.
- •Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
- •Subjects with uncontrolled Diabetes and Hypertension.
- •Subjects using any other investigational drug within 1 month prior to recruitment.
- •Known hypersensitivity to any of the ingredients used in study drug.
- •Pregnant and Lactating females.
- •Subjects currently participating in any other Clinical study.
- •Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria.
结局指标
主要结局
Change in nicotine (chewable tobacco) addiction (average amount of gutka consumed between study visits and number of days required for reduction or complete cessation)
时间窗: Screening visit (Day -3), Baseline visit (Day 0), Visit 1 (day 15), and Visit 2 (Day 30)
次要结局
- 1 Assessment of quality of life (QOL) on WHO QOL Questionnaire.(2. Assessment of level of Energy, level of stamina and physical strength on a 7- point scale)
研究者
Dr Narendra Mundhe
KVTR Ayurvedic College and Hospital Boradi