“A Comparative study of Chandra Avaleha and Tagaradi KwathGhana Vati along with Eladi Gutika in Tobacco ChewingWithdrawal : -A Randomized Clinical Trialâ€
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Changes in clinical Manifestation in tobacco chewing
研究概览
简要总结
NEED & SIGNIFICANCE OF STUDY:
Tobacco addiction has grown to be a huge public health issue
all over the world. Roughly 7 million people worldwide are
killed by tobacco use. The use of tobacco in India accounted
for half of all male and fourth of women’s cancer.
Tobacco includes nicotine and 4000 other chemicals . Nicotine
has a powerful tendency to addict, when taken again and again.
Excessive use of tobacco products leads to clinical changes in
the oral mucosa resulting in Gum disease, oral cancers such as
leukoplakia, and tumours.
ï‚—
It is evident that the incident of tobacco abuse was less
alarming during the ancient period. So very less description has
been given in Ayurvedic classics though vivid description on
alcohol addiction, withdrawal is found under the heading of
madatyaya. But the description of tobacco abuse and the
clinical features of withdrawal and management is not found in
most of the Ayurvedic Classics except a brief description is
found in Yogratnakar.
As there is a lack of description in this field the need of
study about tobacco abuse and its
withdrawal management is very much important.
Aim –
To compare the clinical efficacy of Chandra Avleha and
Tagaradi Kwath Ghanavati along with Eladi Gutika in
tobacco chewing withdrawal.
Hypothesis:-
Null hypothesis (H0):- There is no significant difference
between the effect of Chandra Avleha and Tagaradikwath
Ghanavati along with Eladi Gutika in tobacco chewing
withdrawal symptoms.
Alternate hypothesis (H1):-There is a significant difference
between the effect of Chandra Avleha and Tagaradikwath
Ghanavati along with Eladi Gutika in tobacco chewing
withdrawal symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having history of tobacco chewing addiction and other similar products e.g khaini, zarda, pan masala.
- •2.Clinical manifestation of tobacco withdrawal patient including craving for nicotine, anxiety, depression, restlessness etc which will be presented at that time 3.Patient willing to give consent for clinical trial.
- •4.Patients having history of Tobacco chewing Addiction more than 1 year up to 30 years.
排除标准
- •1.Tobacco addicted patient suffering from cancer of lung, oral cavity, larynx, oesophagus.
- •Patients undergoing Chemotherapy and radiotherapy.
- •Tobacco addicted patients who are suffering from major psychiatric disorders.
- •4.Tobacco addicted patients suffering from major systemic illness like myocardial infarction, ischemic heart disease, pulmonary tuberculosis etc.
- •5.Patients suffering from Diabetes Mellitus.
结局指标
主要结局
1. Changes in clinical Manifestation in tobacco chewing
时间窗: 30 days
withdrawal symptoms.
时间窗: 30 days
次要结局
- 1. Changes in parameters in tobacco chewing withdrawal(symptoms.)