| CTRI Number |
CTRI/2023/08/056871 [Registered on: 24/08/2023] Trial Registered Prospectively |
| Last Modified On: |
23/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on Kadukkai Vadagam in the management of Swasakasam ( Bronchial Asthma) |
|
Scientific Title of Study
|
An open Non-Randomized clinical trial to evaluate the effectiveness of Kadukkai Vadagam in the management of Swasakasam ( Bronchial Asthma) among patients attending Ayothidoss pandithar Hospital, National Institute of Siddha |
| 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 P Dhanakumari |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no :7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9524825994 |
| Fax |
|
| Email |
dhanakumari1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Nalini Sofia |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no :7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8939899363 |
| Fax |
|
| Email |
dr.h.nalinisofia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Dhanakumari |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no :7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9524825994 |
| Fax |
|
| Email |
dhanakumari1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram sanatorium
Chennai 600047 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room no :7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai |
| 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 P Dhanakumari |
Ayothidoss Pandithar Hospital |
Room no:7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai
Kancheepuram
TAMIL NADU |
9524825994
dhanakumari1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Siddha |
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 |
KADUKAI VADAGAM |
2 vadagam(800 to 1000 mg) bds with warm water for 48 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults who are diagnosed with bronchial asthma are included in the study
2.Patients with a clinical symptoms of Swasakasam -Cough with or without expectoration,Recurrent episodes of Wheezes, Tightness of
chest,Dyspnea.,Breathing difficulty.
(Any of 2 or more symptoms will be included)
3.Patient who are willing to take radiological investigation and provide
blood sample for lab investigation.
4.Patient who are willing to undergo Pulmonary function test
5.FEV1 is 50% to 80% |
|
| ExclusionCriteria |
| Details |
1.Diabetes mellitus (Uncontrollable)
2.K/C/O Cardiac disease
3.K/C/O Renal disease
4.K/C/O Other lung diseases
5.Pregnancy
6.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 the values of pulmonary function
test |
8 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement in the clinical signs & symptoms by Asthma control
questionnaire pre & post treatment
2.Laboratory parameters such as IgE, Absolute Eosinophil Count (AEC) ,pre & post treatment |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
04/09/2023 |
| 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="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
|
BACKGROUND: SWASAKASAM is due to the derangement of kapham humor.The increased kapham either with vatham or pitham affects nostrils, throat ,respiratory pathways and lungs. This causes more inflammation leading to disturbances in inspiration and expiration. According to YUGI VAITHIYA CHINTHAMANI 800,Kasam can be classified as 12 types and swasakasam is one among them. The important causes of the diseases are exposure to cold foods, water and climate, inhalation of smoke, allergic items, intake of non vegetarian, starving on hunger ,stealing foods, uttering false talks etc,.This is an open clinical trial that evaluates the effectiveness of KADUKAI VADAGAM in the management of SWASAKASAM(Bronchial Asthma) OBJECTIVE : PRIMARY OBJECTIVE : 1.To evaluate the clinical effectiveness of KADUKKAI VADAGAM in the Management of SWASAKASAM (BRONCHIAL ASTHMA) by using pulmonary function test. 2.To observe the changes in clinical symptoms by asthma control questionnaire 3.The Standardization of the trail drug will be done as per PLIM guidelines. SECONDARY OBJECTIVE : To observe the changes in clinical laboratory parameters such as IGE,AEC, before and after treatment METHODOLOGY: A total of 30 diagnosed patients of Swasakasam( Bronchial Asthma) within the age limit of 18 to 60 years willing to participate in the study by signing the consent form will be enrolled in the study based on inclusion criteria. Known case of Diabetes mellitus (Uncontrollable), Cardiac disease, Renal disease, and Other lung diseases will be excluded. OUTCOME: PRIMARY OUTCOME: .Primary outcome is assessed mainly by the values of pulmonary function test, and improvement in the clinical signs and symptoms by Asthma control questionnaire pre and post treatment. SECONDARY OUTCOME: Laboratory parameters such as IgE, Absolute Eosinophil Count (AEC) ,pre and post treatment. RESULTS AND DISCUSSION : The result will be statistically analysed KEYWORDS: Swasakasam, Bronchial Asthma, kadukai vadagam |