CTRI Number	CTRI/2017/06/008787 [Registered on: 08/06/2017] Trial Registered Retrospectively
Last Modified On:	12/04/2021
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Ayurveda
Study Design	Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study Modification(s)	Clinical study of JPT-25 capsules in people with smoking habits
Scientific Title of Study	A Two Arm, Double Blind, Randomized, Prospective, Multi centric, Placebo controlled, Clinical Study to Evaluate Efficacy and Safety of JPT-25 in Smokers
Secondary IDs if Any	Secondary ID  Registry  JPT25-01/2016, Version 1.0, Dated 8.10.2016  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Narendrakumar Bhanudas Mundhe   Address  KVTR Ayurvedic College Boradi OPD No 5 Ground Floor Department of Kayachikitsa KVTR Ayurvedic College Boradi Tal Shirpur Dist Dhule Dhule MAHARASHTRA 425428 India  Phone  09850378206   Fax     Email  drnbmundhe@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Sanjay Tamoli  Address  Target Institute of Medical Education and Research 205, B Wing, Blue Diamond Society, Nayagoan, Dahisar West, Mumbai Mumbai (Suburban) MAHARASHTRA 400068 India  Phone  9322522252   Fax     Email  sanjaytamoli@hotmail.com
Details Contact Person Public Query Modification(s)	Name  Dr Sanjay Tamoli  Address  Target Institute of Medical Education and Research 205, B Wing, Blue Diamond Society, Nayagoan, Dahisar West, Mumbai Mumbai (Suburban) MAHARASHTRA 400068 India  Phone  9322522252   Fax     Email  sanjaytamoli@hotmail.com
Source of Monetary or Material Support Modification(s)	Gurseet Singh Flat No.1302/B-Wing Duplex Heights CHS, Tower No.6 Yamuna Nagar behind Millat Nagar Bus stop Oshiwara Mumbai Maharashtra 400053
Primary Sponsor Modification(s)	Name  Gurseet Singh  Address  Flat No.1302/B-Wing, Duplex Heights CHS, Tower No.6 Yamuna Nagar behind Millat Nagar Bus stop Oshiwara Mumbai Maharashtra 400053   Type of Sponsor  Other []
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 3   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Shishir Pande  Ayurved Seva Sangh, Ayurved Sanshodhan Vibhag, Ganeshwadi, Panchvati, Nasik  OPD No 9 Ground Floor Ayurved Seva Sanghs Ayurved Mahavidyalaya, Ganeshwadi, Panchvati, Nashik – 422003 Nashik   9420830818 shishir.nsk@gmail.com  Dr Maheshkumar Harit  D. Y. Patil University, School of Ayurveda, Nerul, Navi Mumbai   OPD No. 1 Ground Floor Department of Kayachiktsa D. Y. Patil University School of Ayurveda Nerul Navi Mumbai 400706 Mumbai   9322217607 drmaheshkharit@rediffmail.com  Dr Narendrakumar B Mundhe  KVTR Ayurvedic College Boradi  OPD No 5 Ground Floor Department of Kayachikitsa KVTR Ayurvedic College Boradi Tal Shirpur Dist Dhule Dhule   9850378206 drnbmundhe@gmail.com
Details of Ethics Committee	No of Ethics Committees= 3   Name of Committee  Approval Status  Institutional Ethics Committee, ASS Ayurved Mahavidyalaya, Nashik   Approved  Institutional Ethics Committee, D. Y. Patil University, School of Ayurveda, Nerul, Navi Mumbai  Approved  KVTR Ayurvedic College, Boradi, Institutional Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Smokers
Intervention / Comparator Agent	Type  Name  Details  Intervention  JPT -25 Tablet and or Capsules  JPT -25 Tablet and or Capsules contains Kaucha, Ashvagandha, Bala, Draksha, Sunthi, Yashtimadhu with permitted excipients, preservative etc. Dosage and Treatment Duration: 2 capsules or tablets twice daily orally after food with water for a period of 90 days   Comparator Agent  Placebo  Placebo contains permitted excipients, preservative etc. Dosage and Treatment Duration: 2 capsules or tablets twice daily orally after food with water for a period of 90 days
Inclusion Criteria	Age From  18.00 Year(s) Age To  70.00 Year(s) Gender  Both  Details  1. Subjects smoking a minimum of 5 cigarettes or bidis daily for at least 3 years and showing a high level of alveolar CO levels. 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 the 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 Severe/Chronic disease. 2. Known subject of any active malignancy. 3. Subjects giving a history of significant cardiovascular event less than 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. Pregnant and Lactating females.
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	Pre-numbered or coded identical Containers
Blinding/Masking	Participant and Investigator Blinded
Primary Outcome	Outcome  TimePoints  1. Assessment of cessation of smoking (reduction or complete giving up) 2. To assess changes in Lung capacity by using spirometry   Day -5, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
Secondary Outcome	Outcome  TimePoints  1. Monthly assessment lung capacity measured by a Spirometer 2. Assessment of monthly changes in CO and COHb levels 3. Assessment of quality of life on WHO QOL Questionnaire 4. Assessment of Cardiac risk markers 5. To assess level of Energy, stamina and physical strength 6. Level of stress using VAS 7. To assess serum cortisol and Total Testosterone 8. To assess anxiety on HAMA 9. Physician’s Global evaluation 10. Global assessment of overall safety of drugs  Day -5, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90
Target Sample Size	Total Sample Size="100" Sample Size from India="100"
Phase of Trial	Phase 2/ Phase 3
Date of First Enrollment (India) Modification(s)	15/11/2016
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	Not yet Done
Brief Summary Modification(s)	Brief Methodology: It is A Two Arm, Double Blind, Randomized, Prospective, Multi centric, Placebo controlled, Clinical Study to Evaluate Efficacy and Safety of JPT-25 (JPT -25 Tablet and or Capsules contains Kaucha, Ashvagandha, Bala, Draksha, Sunthi, Yashtimadhu with permitted excipients, preservative etc) in 100 Smokers. The study will be conducted at three sites in India. As per computer generated randomization list, subjects will be randomized to one of the two study groups either study drug or placebo. The dose of the drug or placebo would be 2 capsules or tablets two times daily orally after meals for 90 days. The primary outcome measures will be to assess cessation of smoking (reduction or complete giving up) and changes in Lung capacity by using spirometry on Day -5, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90. The secondary objectives will be to assess monthly changes in lung capacity measured by a Spirometer , monthly changes in CO and COHb levels, quality of life (QOL) on WHO QOL Questionnaire, Changes in the Cardiac risk markers (Apolipoprotein A and B), changes in level of Energy, level of stamina and physical strength, changes in level of stress using Visual Analogue Scale, changes in serum cortisol levels, changes in anxiety on HAMA scale , chest expansion by measuring chest circumference (Axilla and Xiphoid process) and chest diameter (AP and ML), changes in Total Testosterone levels, Physician’s Global evaluation for overall change on CGI-I Scale, clinical symptoms related to smoking, adverse Drug Reaction and post-treatment clinically significant abnormal laboratory parameters, Global assessment of overall safety of JPT-25 as per the physician and subject on Day -5, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90. Results: A total of 103 subjects completed the study (52 in JPT-25 group and 51 in placebo group). Statistical analysis was done to evaluate the changes form baseline to follow up visits within the group and between the groups. Results: A significant reduction (p<0.05) in smoking was observed in JPT-25 group as compared to placebo over a period of 90 days. Also there was a significant reduction in the CO and COHb level in JPT-25 group as compared to Placebo. Significant improvement was observed in Quality of Life, energy and stamina levels, reduction of stress level. No significant changes in safety laboratory parameters and adverse reaction were observed.  Conclusion:  Three months of treatment with JPT-25 tablet helps in cessation of smoking. JPT-25 helps to improve quality of life of smokers along with improvement in the levels of energy, stamina and physical strength and reduction in levels of stress. JPT-25 tablet, a nicotine free herbal composition, can be recommended as a safe and effective remedy for de-addiction of smoking along with improving health related problems arising due to smoking.