CTRI/2023/07/055111 [Registered on: 12/07/2023] Trial Registered Prospectively
Last Modified On:
20/02/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A Clinical Study on SMOTECT-AZAADI granules
Scientific Title of Study
A Two Arm, Open Label, Randomized, Multi centric, Interventional, Prospective, Clinical Study to Evaluate Efficacy and Safety of SMOTECT-AZAADI granules in comparison with Nicotine Replacement Therapy (NRT) in Tobacco users (Chewing)
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
SMOTECTAZAADI/NRT/2023/1, Version 1.0, 11th April 2023
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
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 Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai 400064
Mumbai (Suburban) MAHARASHTRA 400064 India
Phone
09322522252
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 Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai 400064
Khemdas Ayurveda Hospital, Parul Institute of Ayurved and Research
Department of Kayachikitsa, OPD No. 8. Ground, Floor, Khemdas Ayurveda Hospital,
Parul Institute of Ayurved and Research, Parul University, AP
Limda, Tal – Waghodia, Vadodara, Gujarat -391760. Vadodara GUJARAT
9096082950
dr.vaishalid@gmail.com
Dr Narendra Mundhe
KVTR Ayurvedic College and Hospital Boradi
Department of Kayachikitsa, OPD No 5, Ground Floor, KVTR Ayurvedic College and Hospital, Boradi, Tal. Shirpur, Dist Dhule, 425428 Dhule MAHARASHTRA
Institutional Ethics Committee, Ayurved seva Sangh’s Ayurved Mahavidyalaya, Nashik
Approved
Institutional Ethics Committee, Khmedas Ayurved College and Hospital, Parul University
Approved
Institutional Ethics Committee, KVTR Ayurved College and Hospital, Boradi
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy Volunteers
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Intervention Arm
Drug
Other than Classical
(1) Medicine Name: SMOTECT AZAADI GRANULES , Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Subjects will be asked to chew 5 gm granules twice daily after food for 3 months. The total study duration will be 120 Days of which 90 days will be study drug administration period. After stopping the study interventions subjects will be followed up for further 30 days for evaluating relapse of use of Gutka (Tobacco)
2
Comparator Arm (Non Ayurveda)
-
NRT
Subjects will be asked to take NRT in a dose of 2 mg twice daily for 3 months. The total study duration will be 120 Days of which 90 days will be study drug administration period. After stopping the study interventions subjects will be followed up for further 30 days for evaluating relapse of use of Gutka (Tobacco)
Inclusion Criteria
Age From
18.00 Year(s)
Age To
70.00 Year(s)
Gender
Both
Details
1. Subjects habituated to a minimum of 3 times of Tobacco Chewing daily (Gutka etc.) for the last 1-year.
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; 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 any severe/chronic disease which in the opinion of the investigator will be detrimental to the subject for participating in the study.
2. Known case of any active malignancy.
3. Subjects giving history of significant cardiovascular event 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 the 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 stated in the exclusion criteria.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Difference in cessation of chewing of tobacco/gutka etc. (reduction or complete cessation, with respect to number of users & frequency of usage)
1. Difference in effect on mouth opening capacity
2. Change in oral health-related parameters
3. Change in quality of life (QOL) assessed using WHO QOL BREF Questionnaire
4. Change in level of Energy, level of stamina & physical strength
5. Assessment of onset & duration of action with respect to levels of energy, freshness, and alertness
6. Change in level of stress using PSS
7. Changes in symptoms related to digestive system
8. Change in sleep quality assessed using PSQI
9. Assessment of physician’s and subject’s global evaluation for overall change
10. Changes in clinical symptoms related to Chewing Tobacco including
11. Assessment of relapse of use of Gutka (Tobacco)
12. Assessment of Adverse Drug Reaction and laboratory investigations
13. Global assessment of overall safety of study products
14. Assessment of overall sensorial feeling on the consumption of IP
It is a two arm, open label, randomized, multi centric, interventional, prospective, clinical study to evaluate efficacy and safety of SMOTECT-AZAADI granules in comparison with Nicotine Replacement Therapy (NRT) in Tobacco users (Chewing). Subjects will be randomized to one of the two study groups in 1:1 ratio. Subjects in the SMOTECT-AZAADI granules will be asked to chew 5 gm granules twice daily after food for 3 months. Subjects in the NRT group will be asked to take NRT in a dose of 2 mg twice daily for 3 months. The total study duration will be 120 Days of which 90 days will be study drug administration period. After stopping the study interventions subjects will be followed up for further 30 days for evaluating relapse of use of Gutka (Tobacco). The study will be carried out at 2 to 3 centers in India. The primary objective of the study is to assess difference in cessation of chewing of tobacco/gutka etc. (reduction or complete cessation, with respect to number of users and frequency of usage). The secondary objectives of the study will be to assess difference in effect on mouth opening capacity, change in oral health-related parameters including ulcers, coloration, taste, change in quality of life (QOL) assessed using WHO QOL BREF Questionnaire, change in level of energy, level of stamina and physical strength, assessment of onset and duration of action with respect to levels of energy, freshness, and alertness after consumption of study drug, change in level of stress using PSS, changes in symptoms related to digestive system, change in sleep quality, physician’s and subject’s global evaluation for overall change, changes in clinical symptoms related to Chewing Tobacco, relapse of use of Gutka (Tobacco) after stopping the study product after 90 days, adverse drug reaction and laboratory investigations, global assessment of overall safety of study products and overall sensorial feeling on the consumption of IP on screening Visit (Up to 7 days), Baseline visit (Day 0), Visit 1 (Day 15), Visit 2 (Day 30), Visit 3 (Day 45), Visit 4 (Day 60), Visit 5 (Day 75), Visit 6 (Day 90), Visit 7 (Day 120)
Results and Conclusion:
The study concludes that
consumption of Azaadi granules helps reduction in oral chewable tobacco
addiction as well as complete cessasation. The results with the use of Azaadi
granules were comparable with nicotine replacement therapy (NRT). It was also observed
that there was significant improvement in overall quality of life, energy
levels, stamina levels. Azaadi granules showed significant reduction in stress
levels. Azaadi granules were well tolerated and did not produce any adverse
effects. Laboratory related parameters also showed non-significant change with
the use of Azaadi granules