| CTRI Number |
CTRI/2025/07/090758 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Jyotishmati Lozenges (Polyherbal) in habitual Tobacco Smokers. |
|
Scientific Title of Study
|
Randomised Comparative Clinical Trial Of Jyotishmati Lozenges For The Withdrawal Effects Due To Tobacco Smoking Addiction |
| 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 Yadunath Waykole |
| Designation |
Associate Professor |
| Affiliation |
Dr. D. Y. Patil College Of Ayurved And Research Centre, Pimpri, Pune, 18 |
| Address |
OPD NO 15 department of Agadtantra Dr d Y Patil college of Ayurved and hospital Research centre Pimpri Pune
OPD NO 15 department of Agadtantra Dr d Y Patil college of Ayurved and hospital Research centre Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8308858827 |
| Fax |
|
| Email |
vd.yadunath55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arati Shinde |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil College Of Ayurved And Research Centre, Pimpri, Pune, 18 |
| Address |
OPD NO 15 department of Agadtantra Dr d Y Patil college of Ayurved and hospital Research centre Pimpri Pune
OPD NO 15 department of Agadtantra Dr d Y Patil college of Ayurved and hospital Research centre Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9689933614 |
| Fax |
|
| Email |
abhayarati@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yadunath Waykole |
| Designation |
Associate Professor |
| Affiliation |
Dr. D. Y. Patil College Of Ayurved And Research Centre, Pimpri, Pune, 18 |
| Address |
OPD NO 15 department of Agadtantra Dr d Y Patil college of Ayurved and hospital Research centre Pimpri Pune
OPD NO 15 department of Agadtantra Dr d Y Patil college of Ayurved and hospital Research centre Pimpri Pune
Pune
MAHARASHTRA
411039
India |
| Phone |
8308858827 |
| Fax |
|
| Email |
vd.yadunath55@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Yadunath Waykole |
| Address |
Associate Professor department of agadtantra Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune 18 |
| Type of Sponsor |
Other [self sponsor ] |
|
|
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 Yadunath Waykole |
Dr D Y Patil ayurved hospital pimpri pune OPD No 15 Department of Agadtantra |
OPD NO 15 department of Agadtantra Dr d Y Patil college of Ayurved and hospital Research centre Pimpri Pune 411018
Pune
MAHARASHTRA |
8308858827
vd.yadunath55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr D Y Patil College Of Ayurved and Research Centre Pimpri Pune 18 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F172||Nicotine dependence. Ayurveda Condition: GARAVISHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Jyotishmatyadi lozenges, Reference: NA, Route: Oral, Dosage Form: Lozenges, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -chewing after food | | 2 | Comparator Arm (Non Ayurveda) | | - | nicotine gum | nicotine gum 2 mg |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. individuals from 15 to 60 years will be included
2. individuals of both sexes will be included
3. Only tobacco smokers will be selected |
|
| ExclusionCriteria |
| Details |
1. All types of known malignancies
2. All types of oral lesions having any known underlying systemic pathology, such as syphilis, systemic lupus erythematous
3. Without a history of tobacco smoking addiction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Jyotishmati lozenges in tobacco smokers in reduction of withdrawal effects |
baseline 0 day assessment
15th day
30th day
45th day and 60th day assessment Total 4 follow ups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess palatability of jyotoshmati lozenges
To assess adverse events if any
|
baseline 0 day assessment
15th day
30th day
45th day & 60th day assessment Total 4 follow ups |
|
|
Target Sample Size
|
Total Sample Size="67"
Sample Size from India="67"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Very little work has been done on the role of natural herbal agents in smoking cessation. This clinical trial was designed to determine the effectiveness and mode of action of natural herbal agents in smoking cessation. To assess the effect of Jyotishmatyadi lozenges on the withdrawal effect due to tobacco smoking, a randomized comparative clinical trial of Jyotishmatyadi lozenges for the Withdrawal effect due to tobacco smoking addiction is designed. The objective of the study is to assess the effect of Jyotishmatyadi lozenges on the withdrawal effect due to tobacco smoking. |