| CTRI Number |
CTRI/2024/09/073808 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Siddha poly herbal formulation in tobacco de addiction - A Pilot sutdy |
|
Scientific Title of Study
|
Effectiveness of Siddha poly herbal formulation (pugaiyilai nanju murivu kudineer) in tabacco de addiction a pilot study in tobacco deaddiction - A Pilot study |
| 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 S Thamodharan |
| Designation |
Assistant professor |
| Affiliation |
Government SIddha Medical College |
| Address |
Department of Nanju Maruthuvam
Government Siddha Medical College
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9655693102 |
| Fax |
|
| Email |
thamusiddha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Thamodharan |
| Designation |
Assistant professor |
| Affiliation |
Government SIddha Medical College |
| Address |
Department of Nanju Maruthuvam
Government Siddha Medical College
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9655693102 |
| Fax |
|
| Email |
thamusiddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Thamodharan |
| Designation |
Assistant professor |
| Affiliation |
Government SIddha Medical College |
| Address |
Department of Nanju Maruthuvam
Government Siddha Medical College
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9655693102 |
| Fax |
|
| Email |
thamusiddha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical college Arumbakkam Chennai 106 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 S Thamodharan |
Government Siddha Medical College |
Department of Nanju Maruthuvam
Government Siddha Medical College
Arumbakkam
Chennai
TAMIL NADU |
9655693102
thamusiddha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Siddha Medical college Arumbakkam Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Persons having habit of smoking 10-20 cigarette/day for more than a year along with or
without the symptoms of burning acid sensation, nausea, vomiting, abdominal pain,
hypersalivation, Tachycardia, hypertension, tachypnoea, bradycardia, hypotension, respiratory
depression, confusion, headache, sweating, agitation, restlessness, lethargy 3
Persons Willing to Undergo Routine Blood Investigation.
Persons Willing to Participate in Trial and Signing Consent Form. |
|
| ExclusionCriteria |
| Details |
Cerebro vascular accident
Myocardial infarction or Angina pectoris.
Pulmonary tuberculosis,
Bronchial Asthma,
Chronic obstructive pulmonary disease,
Any terminal illness
Pregnant and lactating women will be excluded from this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduce CRP to 0-3, reduced FTND score to 1 |
measure CRP, FTND score for 4th week, 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| increase lung capacities |
2 year |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/10/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Upon approval from the Institutional Ethics Committee (IEC) and registration with the Clinical
Trials Registry - India (CTRI), screening of potential participants will commence using a Screening
Proforma. Eligible individuals will be enrolled after providing informed consent, During the baseline visit, participants
will undergo a comprehensive clinical examination and history-taking, Additionally, urine critinine levels will be measured using test kits to assess tobacco
exposure. Lung function will be evaluated through Pulmonary Function Tests (PFT), and basic
laboratory investigations (Form-III) such as Complete Blood Count (CBC), Erythrocyte Sedimentation
Rate (ESR), Blood Sugar levels, Liver Function Tests (LFT), Renal Function Tests (RFT), Lipid
Profile, and C-Reactive Protein (CRP) will be conducted. Chest expansion will be measured by
assessing chest circumference. Participants daily cigarette consumption will be recorded at 15-day
intervals, and the intensity of nicotine addiction will be assessed using the Fagerström Test for Nicotine
Dependence (FTND) on a fortnight basis. Upon completion of the study period, all baseline assessments
will be repeated. urine samples will be analyzed. Any adverse events will be
recorded, irrespective of the relationship to the study intervention. In case of any serious adverse events,
the intervention will be immediately discontinued and will be reported to pharmacovigilance
centre.
|