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
|
|
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
|
|
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). |