| CTRI Number |
CTRI/2024/06/069089 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The Effect of Devdarvyadi dhoomra in Tobacco Smoking Withdrawal Syndrome |
|
Scientific Title of Study
|
A Clinical Study To Evaluate the Efficacy of Devdarvyadi Dhoomra in Tobacco Smoking Withdrawal Syndrome |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| National Institute of Ayurveda Agad Tantra Room 212 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Professor Anita Sharma |
| Designation |
Head of Department Agad Tantra |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda Jorawar Singh Gate Madhav Villas Jaipur Agad Tantra Room 212
Jorawar Singh Gate Madhav Villas Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414078563 |
| Fax |
|
| Email |
anita31sharma@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Anita Sharma |
| Designation |
Head of Department Agad Tantra |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda Jorawar Singh Gate Madhav Villas Jaipur Agad Tantra Room 212
Jorawar Singh Gate Madhav Villas Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414078563 |
| Fax |
|
| Email |
anita31sharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubhangi Sharma |
| Designation |
M D Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda Jorawar Singh Gate Madhav Villas Jaipur Agad Tantra Room no 212
Jorawar Singh Gate Madhav Villas Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9509305067 |
| Fax |
|
| Email |
sharmashubhangi0307@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Johwra singh Gate Madhav villas , jaipur Agad tantra room 212 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawar Singh Gate Madhav Villas Jaipur |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Shubhangi Sharma |
National Institute of Ayurveda |
Jorawar Singh gate Madhav villas jaipur Agad Tantra room number 212
Jaipur
RAJASTHAN |
9509305067
sharmashubhangi0307@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J705||Respiratory conditions due to smoke inhalation. Ayurveda Condition: DHUMAPANA-ATIYOGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Devdarvyadi Dhoomra , Reference: Rastantra Sara Sangrah part 1 in Lepa Melham Prakaran , Route: Oral, Dosage Form: Varti/ Suppository, Dose: 10(NA), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -10 Devdarvyadi Dhoomra in divided doses 2 hourly in a whole day will be given |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patient of tobacco smoking addiction only.
Clinical manifestation of tobacco smoking withdrawal patient including craving for nicotine anxiety depression restlessness
Patient having history of Tobacco smoking more than 1 year
Either sex
Patient having Fagerstrom for Nicotine Dependence score ranging 5 to 10
|
|
| ExclusionCriteria |
| Details |
Tobacco smoking addicted patient suffering from cancer
Tobacco smoking addicted patient who are suffering from major psychiatric disorders
Tobacco smoking addicted patients suffering from major systemic illness like myocardial infraction ischemic heart disease pulmonary tuberculosis diabetes mellitus hypertension
Patient having Fagerstrom for Nicotine Dependence score ranging 0 to 4 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in clinical manifestation of Tobacco smoking withdrawal syndrome on the basis of DSM 5 criteria |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in Liver Function Test, Lipid profile
Changes in Spirometry Volume and Capacity |
45 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 tumors . As there is a lack of description in this field of concern, the need of the study about toabcco abuse and its withdrawal management is very much important . So it is hypothesised that with the dhoomra ( herbal smoking ) can produce the good feel effect and it will produce placebo effect . Simultaneously it will subside the tobacco dependence. As the content of this dhoomra having medhya effect so it can correct the altered brain function caused by tobaccco consumption . |