| CTRI Number |
CTRI/2022/07/043670 [Registered on: 04/07/2022] Trial Registered Prospectively |
| Last Modified On: |
24/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
A Purview of Observational Study on the Standardization of Siddhar Theraiyars Proclamation "KABATHINAIYANDRI KAASASWASAM KAANATHU"(Bronchial asthma) |
|
Scientific Title of Study
|
A purview of observational study on the standardization of siddhar theraiyars proclamation "KABATHINAIYANDRI KAASASWASAM KAANATHU" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Kiruthika |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college and hospital, Palayamkottai |
| Address |
Department of Noi Naadal , Government siddha medical college and hospital, Palayamkottai, Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8220258775 |
| Fax |
|
| Email |
p.kiruthikabsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S SUNDARARAJAN MDs |
| Designation |
Reader |
| Affiliation |
Government Siddha Medical college and Hospital,Palayamkottai |
| Address |
Department of Noi Naadal,
Government Siddha Medical college and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S SUNDARARAJAN MDs |
| Designation |
Reader |
| Affiliation |
Government Siddha Medical college and Hospital,Palayamkottai |
| Address |
Department of Noi Naadal,
Government Siddha Medical college and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college and hospital, Palayamkottai. |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital Palayamkottai |
| Address |
Government siddha medical college and hospital, Palayamkottai, Tirunelveli. |
| 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 Kiruthika |
Government siddha medical college and hospital. |
Room no 2 , Department of Noi Naadal, Government siddha medical college and hospital, Palayamkottai, Tirunelveli.
Tirunelveli
TAMIL NADU |
8220258775
p.kiruthikabsms@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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with presenting symptoms of
Shortness of breath
Wheezing
Cough
Chest tightness
Sneezing. |
|
| ExclusionCriteria |
| Details |
Age below 14 yrs and above 65 yrs
Illaippu Noi
Kandakragam
Thamaraga suvasam
Vulnerable group
Pregnancy and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To analyze the statement in three ways
Whether the chronic derangement of kabham leads to kaasam,swasam.
Whether vadham or pitham accompanied with kabham causes kaasam ,swasam.
Whether kaasam ,swasam is predominant in kaba thegies.
To study Naadi Nadai for patients with kaasam ,swasam.
|
1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study Neerkuri and Neikuri for patients with kaasam ,swasam.
To study Manikkadai Nool for patients with kaasam ,swasam
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
04/07/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Study is designed to assess the siddha diagnostic procedures especially Neerkuri and Neikuri in patients of kaasaswasam to validate the statement proclaimed by sage Theraiyar "kabathinaiyandri kaasaswasam kaanathu". Assessment of other diagnostic methods such as Naadi Nadai and Manikkadai Nool is also done. |