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CTRI Number  CTRI/2024/01/061028 [Registered on: 01/01/2024] Trial Registered Prospectively
Last Modified On: 27/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   Clinical effectiveness of Kasthuri Karuppu in the management of Eraippu Noi (Bronchial Asthma)  
Scientific Title of Study   A Pilot study on the Clinical effectiveness of Kasthuri Karuppu in the management of Eraippu Noi (Bronchial Asthma)  
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 G Dhivya 
Designation  PG SCHOLAR 
Affiliation   
Address  Room no 1 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Kancheepuram
National Institute of Siddha
Kancheepuram
TAMIL NADU
600047
India 
Phone  9500934305  
Fax    
Email  dhivyahema97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr H VETHA MERLIN KUMARI 
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Room no 1 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Kancheepuram

Kancheepuram
TAMIL NADU
600047
India 
Phone  9894782366  
Fax    
Email  dr.vetha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr G Dhivya 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Room no 1 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Kancheepuram

Kancheepuram
TAMIL NADU
600047
India 
Phone  9500934305  
Fax    
Email  dhivyahema97@gmail.com  
 
Source of Monetary or Material Support  
Department of Maruthuvam Ayothidass Pandithar Hospital National Institute of Siddha Tambaram Sanatorium Kancheepuram District Tamilnadu 600047 
 
Primary Sponsor  
Name  National Institute of Siddha  
Address  National Institute of Siddha Tambaram Sanatorium Kancheepuram 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G Dhivya  Ayothidass Pandithar Hospital  Room no 1 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Kancheepuram
Kancheepuram
TAMIL NADU 
9500934305

dhivyahema97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J454||Moderate persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kasthuri karuppu  65 to 130mg twice a day after food with honey for 14 days 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age between 18 and 60years
Sex: Male ,Female &Transgender
Patients who are willing to undergo Pulmonary Function Test (FEV1-50-80%)
will be taken
Patients who are willing to undergo radiological investigations and provide
blood sample for lab investigations
 
 
ExclusionCriteria 
Details  K/C/O Restrictive Lung diseases
K/C/O Pulmonary tuberculosis
K/C/O Emphysema
K/C/O Pleural effusion
K/C/O Pneumothorax
K/C/O Cardiac diseases
K/C/O Renal diseases
Pregnancy
Lactation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome is assessed by comparing the lung volumes and capacities in pulmonary function tests along with graph PFT of obstructive pattern before and after treatment
 
15th day
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome is assessed by comparing the improvement of clinical symptoms of
Eraippu noi patients by using Asthma Control Questionairre and laboratory parameters such as IgE,
Absolute Eosinophil Count (AEC),Erythrocyte sedimentation rate (ESR) before and after treatment 
15th day 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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 
Date of First Enrollment (India)   11/01/2024 
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="0"
Months="6"
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   This is a Pilot study on the Clinical effectiveness of ’’Kasthuri Karuppu’’ in the management of Eraippu Noi (Bronchial Asthma). It will be assessed  through Pulmonary Function Test ( PFT) with the help of spirometry /Peak Expiratory Flow Rate (PEFR),  clinical laboratory parameters and by using Asthma Control Questionairre before and after treatment.. Asthma is a chronic inflammation is associated with airway hyper-responsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness and coughing particularly at night and in the early morning. These episodes are usually associated with widespread but variable airflow obstruction within the lung that is often reversible, either spontaneously or with treatment .The aim of the study is to  evaluate the effectiveness of “KASTHURI KARUPPU” in the management of ERAIPPU NOI (BRONCHIAL ASTHMA). 
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