Role of Chandra Avaleha and Tagaradi Kwath Ghana Vati along withEladi Gutika in Tobacco Chewing withdrawal symptoms

Phase 2

Not yet recruiting

Conditions: Nicotine dependence. Ayurveda Condition: MANOVAHASROTOVIKARAH,

Registration Number: CTRI/2022/06/043253

Lead Sponsor: National Institute of Ayurveda Jaipur

Brief Summary: 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 â€“

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Changes in clinical Manifestation in tobacco chewing	30 days
withdrawal symptoms.	30 days

Secondary Outcome Measures

Name	Time	Method
1. Changes in parameters in tobacco chewing withdrawal	symptoms.

Trial Locations

Locations (1): OPD, National Institute of Ayurveda
🇮🇳
Jaipur, RAJASTHAN, India
OPD, National Institute of Ayurveda
🇮🇳Jaipur, RAJASTHAN, India
Dr Kishore Das
Principal investigator
8876918050
kishore112d@gmail.com