| CTRI Number |
CTRI/2025/04/084290 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the Effectiveness of Modified Tambul Churna in Reducing Chewing Tobacco Use – A Single-Arm Clinical Trial |
|
Scientific Title of Study
|
Evaluation of efficacy of modified Tambul Churna for minimizing the frequency of chewing tobacco products – A single arm clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumit Dhote |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Salod Wardha |
| Address |
Department of Agadtantra Evum Vidhivaidyaka Datta Meghe Institute of Higher Education And Research centre Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9370607518 |
| Fax |
|
| Email |
sumitdhote12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Chalakh |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Salod Wardha |
| Address |
Department of Agadtantra Evum Vidhivaidyaka Datta Meghe Institute of Higher Education And Research centre Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9850366073 |
| Fax |
|
| Email |
spchalakh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Dhote |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Salod Wardha |
| Address |
Department of Agadtantra Evum Vidhivaidyaka Datta Meghe Institute of Higher Education And Research centre Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9370607518 |
| Fax |
|
| Email |
sumitdhote12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha Maharashtra 442001 India |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha |
| Address |
Department of Agadtantra Evum Vidhivaidyaka Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha Maharashtra 442001 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sumit Dhote |
Mahatma Gandhi Ayurved College Salod Wardha |
Department of Agadtantra Evum Vidhivaidyaka Datta Meghe Institute of Higher Education And Research centre Salod Wardha
Wardha
MAHARASHTRA |
09370607518
sumitdhote12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MGACH And RC Salod Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified. Ayurveda Condition: DUSHIVISHOPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tambul Churna, Reference: Astang sangraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 1 Weeks, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Paricipants of either gender between age of 18 to 40 years willing to get de-addicted.
Paricipants suffering from tobacco product consumption , who will be ready to participate in the study and willing to give written consent.
|
|
| ExclusionCriteria |
| Details |
Participants is not willing.
Participants with oral pathology like(stomatitis oral cancer submucosal fibrosis) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the efficacy of a modified Tambul Churna formulation in minimizing the frequency of chewing tobacco products in habitual users |
Three Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decline in craving intensity among participants. Improvements in urine cotinine levels were observed indicating potential detoxification benefits |
Three Months |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria |