| CTRI Number |
CTRI/2022/06/043253 [Registered on: 14/06/2022] Trial Registered Prospectively |
| Last Modified On: |
20/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Chandra Avaleha and Tagaradi Kwath Ghana Vati along with
Eladi Gutika in Tobacco Chewing withdrawal symptoms |
|
Scientific Title of Study
|
“A Comparative study of Chandra Avaleha and Tagaradi Kwath
Ghana Vati along with Eladi Gutika in Tobacco Chewing
Withdrawal : -A Randomized Clinical Trial†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Anita Sharma MD Ayu PhDAyu |
| Designation |
Professor & HOD Dept. of Agad Tantra, NIA Jaipur |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Room No- 206
Academic Building 2nd floor National Institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414078653 |
| Fax |
|
| Email |
anita31sharma@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kishore Das |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
PG Department of Agadtantra
National Institute of Ayurveda, jaipur
Room No- 209
Jaipur
RAJASTHAN
302002
India |
| Phone |
8876918050 |
| Fax |
|
| Email |
kishore112d@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kishore Das |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
PG Department of Agadtantra
National Institute of Ayurveda, jaipur
Room No- 209
Jaipur
RAJASTHAN
302002
India |
| Phone |
8876918050 |
| Fax |
|
| Email |
kishore112d@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
Amer Road, Near Jorawar Singh Gate, National Institute of Ayurveda,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 Kishore Das |
OPD, National Institute of Ayurveda |
OPD No- 25, Jorawar singh Gate
Amer Road
Jaipur
RAJASTHAN |
8876918050
kishore112d@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee, National Institute of Ayurveda, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F172||Nicotine dependence. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tagaradi Kwath Ghan Vati with Eladi Gutika, Reference: Yogratnakar ralapak Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chandraveleha with Eladi Gutika, Reference: Rasatantrasaara Siddhayoga Sangraha, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. 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. |
|
| ExclusionCriteria |
| Details |
1.Tobacco addicted patient suffering from cancer of lung, oral
cavity, larynx, oesophagus.
2. Patients undergoing Chemotherapy and radiotherapy.
3. 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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Changes in clinical Manifestation in tobacco chewing
withdrawal symptoms. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in parameters in tobacco chewing withdrawal
symptoms.
2. Change in quality of life of the patients |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/07/2022 |
| 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="0"
Months="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 –
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 |