A Clinical Study on SMOTECT-AZAADI granules
- Conditions
- Healthy Volunteers
- Registration Number
- CTRI/2023/07/055111
- Lead Sponsor
- Gurseet Singh,Project Happiness Pvt Ltd
- Brief Summary
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 thatconsumption of Azaadi granules helps reduction in oral chewable tobaccoaddiction as well as complete cessasation. The results with the use of Azaadigranules were comparable with nicotine replacement therapy (NRT). It was also observedthat there was significant improvement in overall quality of life, energylevels, stamina levels. Azaadi granules showed significant reduction in stresslevels. Azaadi granules were well tolerated and did not produce any adverseeffects. Laboratory related parameters also showed non-significant change withthe use of Azaadi granules
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
- Subjects habituated to a minimum of 3 times of Tobacco Chewing daily (Gutka etc.) for the last 1-year.
- 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.
- Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
- 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.
- Known case of any active malignancy.
- Subjects giving history of significant cardiovascular event 12 weeks prior to randomization.
- Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
- Subjects with uncontrolled Diabetes and Hypertension.
- Subjects using any other investigational drug within 1 month prior to recruitment.
- Known hypersensitivity to any of the ingredients used in the study drug.
- Pregnant and Lactating females 10.
- Subjects currently participating in any other Clinical study.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in cessation of chewing of tobacco/gutka etc. (reduction or complete cessation, with respect to number of users & frequency of usage) 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)
- Secondary Outcome Measures
Name Time Method 1. Difference in effect on mouth opening capacity 2. Change in oral health-related parameters
Trial Locations
- Locations (3)
Ayurved Seva Sangh’s, Ayurved Mahavidyalaya, Ganeshwadi
🇮🇳Nashik, MAHARASHTRA, India
Khemdas Ayurveda Hospital, Parul Institute of Ayurved and Research
🇮🇳Vadodara, GUJARAT, India
KVTR Ayurvedic College and Hospital Boradi
🇮🇳Dhule, MAHARASHTRA, India
Ayurved Seva Sangh’s, Ayurved Mahavidyalaya, Ganeshwadi🇮🇳Nashik, MAHARASHTRA, IndiaDr Shishir PandePrincipal investigator9146030818shishir.nsk@gmail.com