| CTRI Number |
CTRI/2025/01/079753 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on Azaadi Rich Granules in gutka users |
|
Scientific Title of Study
|
Clinical study to evaluate efficacy and safety of Smotect Azaadi Rich Granules for its effect on nicotine (tobacco) de-addition in gutka users |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SMOTECTAZAADI/RG/2024/1, Version 1.0, 26th Dec 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narendra Mundhe |
| Designation |
Assistant Professor |
| Affiliation |
KVTR Ayurvedic College and Hospital Boradi |
| Address |
KVTR Ayurvedic College and Hospital Boradi
Department of Kayachikitsa, OPD No 5, Ground Floor,
KVTR Ayurvedic College and Hospital, Boradi,
Tal. Shirpur, Dist. Dhule
Dhule
MAHARASHTRA
425428
India |
| Phone |
9850378206 |
| Fax |
|
| Email |
drnbmundhe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt Ltd |
| Address |
Target Institute of Medical Education and Research Pvt Ltd
A wing 402 A, B, C, Jaswanti Allied Business Centre,
Ramchandra Lane Extension,
Kachpada, Malad West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt Ltd |
| Address |
Target Institute of Medical Education and Research Pvt Ltd
A wing 402 A, B, C, Jaswanti Allied Business Centre,
Ramchandra Lane Extension,
Kachpada, Malad West, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Project Happiness Pvt Ltd
275/2184, Motilal Nagar
No.1, Goregaon (W) Mumbai 400104
|
|
|
Primary Sponsor
|
| Name |
Project Happiness Pvt Ltd |
| Address |
275/2184, Motilal Nagar
No.1, Goregaon (W) Mumbai 400104
|
| Type of Sponsor |
Other [Healthcare Industry] |
|
|
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 Narendra Mundhe |
KVTR Ayurvedic College and Hospital Boradi |
Department of Kayachikitsa, OPD No 5, Ground Floor,
Tal. Shirpur, Dist. Dhule 425428
Dhule
MAHARASHTRA |
9850378206
drnbmundhe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KVTR Ayurved College and Hospital, Boradi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Gutka or tobacco Users |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | NIL | NIL | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Smotect-AZAADI Rich Granules , Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 1(NA), Frequency: sos, Bhaishajya Kal: Samudga, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Subjects will be asked to consume Smotect Azaadi Rich Granules as and when required (having urge to chew tobacco). Subjects will be asked to use not more than 6 pouches (not more than one at a time) daily for 30 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects consuming a minimum of 4 packets (approx. 10 gm) gutka daily for more than 5 years
2. Subjects not suffering from any significant illness (medical or surgical)
3. Subjects of female gender or non-pregnant, non-lactating females. A urine
pregnancy test is required for all female subjects of childbearing potential unless
female subject has had a hysterectomy, tubal ligation, or is greater than or equal 2 years postmenopausal.
4. Subjects willing to follow the procedures as per the study protocol and
voluntarily sign an informed consent form
|
|
| ExclusionCriteria |
| Details |
1. Known cases of Severe or Chronic disease
2. Known subject of any active malignancy.
3. Subjects giving history of significant cardiovascular event less than or equal to 12 weeks prior to randomization.
4. Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
5. Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
6. Subjects with uncontrolled Diabetes and Hypertension.
7. Subjects using any other investigational drug within 1 month prior to recruitment.
8. Known hypersensitivity to any of the ingredients used in study drug. 9. Pregnant and Lactating females.
10. Subjects currently participating in any other Clinical study.
11. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in nicotine (chewable tobacco) addiction (average amount of gutka consumed between study visits and number of days required for reduction or complete cessation) |
Screening visit (Day -3), Baseline visit (Day 0), Visit 1 (day 15), and Visit 2 (Day 30) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Assessment of quality of life (QOL) on WHO QOL Questionnaire.
2. Assessment of level of Energy, level of stamina and physical strength on a 7- point scale
3. Assessment of level of stress using VAS
4. Assessment of change in daytime fatigue on VAS
5. Change in clinical symptoms related to chewable tobacco or gutka
6. Assessment of oral health (mouth opening capacity) and mouth ulcers
7. Change in Global evaluation for overall change on CGI-I Scale as per physician and subjects
8. Assessment of adverse events
9. Change in global assessment of overall safety of study drug as per the physician and subjects
|
Screening visit (Day -3), Baseline visit (Day 0), Visit 1 (day 15), and Visit 2 (Day 30) |
|
|
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)
|
10/02/2025 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It is a clinical
study to evaluate efficacy and safety of Smotect Azaadi Rich Granules for its
effect on nicotine (tobacco) de-addition in gutka users. The study will be
carried out in one to two centers in India. Subjects
will be asked to consume Smotect Azaadi Rich Granules as and when required
(having urge to chew tobacco). Subjects will be asked to use not more than 6 pouches
(not more than one at a time) daily for 30 days. The primary objective of the
study will be to assess change in nicotine (chewable
tobacco) addiction (average amount of gutka consumed between study
visits and number of days required for reduction or complete cessation). The
secondary objectives of the study will be to assess quality of life (QOL) on WHO QOL Questionnaire,
level of Energy, level of stamina and physical strength on a 7- point scale,
level of stress using VAS, change in daytime fatigue on VAS, clinical symptoms
related to chewable tobacco or gutka, oral health (mouth opening capacity) and
mouth ulcers, global evaluation for overall change on CGI-I Scale as per
physician and subjects, adverse events and change in global assessment of
overall safety of study drug as per
the physician and subjects on screening visit (Day -3), Baseline visit (Day 0),
Visit 1 (day 15), and Visit 2 (Day 30) |