| CTRI Number |
CTRI/2018/06/014496 [Registered on: 11/06/2018] Trial Registered Prospectively |
| Last Modified On: |
26/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO ANALYSIS THE PSORIASIS WITH SIDDHA CONCEPT |
|
Scientific Title of Study
|
CHARACTERISTICS OF KALANJAGAPADAI ON THE BASIS OF UYIR THATHUKKAL-A CROSS SECTIONAL STUDY. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M SUJITHA |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Nanju Maruthuvam
Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram sanatorium
chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
8940164101 |
| Fax |
|
| Email |
mk.suji5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R MADHAVAN |
| Designation |
Lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Nanju Maruthuvam
Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram sanatorium
chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9965561656 |
| Fax |
|
| Email |
nanjunoolnis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Sujitha |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Nanju Maruthuvam
Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram sanatorium
chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
8940164101 |
| Fax |
|
| Email |
mk.suji5@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Siddha Tambaram Sanatorium Chennai 47 |
|
|
Primary Sponsor
|
| Name |
Ayothidoss Pandithar Hospital |
| Address |
National Institute of Siddha
Tambaram sanatorium
chennai 47 |
| 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 M Sujitha |
Ayothidoss pandithar hospital |
Out Patient Department Op no 6 Ayothidoss Pandithar hospital National institute of siddha Tambaram Sanatorium Chennai
Tambaram sanatorium Chennai 47
Chennai
TAMIL NADU |
8940164101
mk.suji5@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
Psoriasis (kalanjagapadai), (1) ICD-10 Condition: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients with psoriasis complaint |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Based on Sirappu Maruthuvam text there is no classification of kalanjagapadai. Here I try to classify Kalanjagapadai into three category of Vali, azhal, Iyam by its characteristics features. Medicines selection to kalanjagapadai is vary in people to people.The classification of Kalanjagapadai based on tridosham to improve diagnostic quality and also helpful easy to select medicine. |
15 to 20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/06/2018 |
| Date of Study Completion (India) |
26/09/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Psoriasis is a challenge for the physician,because
chronic generalized psoriasis is one of the miseries that beset mankind causing
shame, embarrassment and compromised life style. From available studies,
prevalence of psoriasis in India ranges from 0.44% to 2.8% it is twice more common in males compared to
females. In text book of siddha maruthuva sirappu female are commonly affected.
but in our study female 30% male 70% .Highest prevalence was noted in the age group of
21-30 and 41-50 years. In our study was 26-45 years and 46-65 years. 12.5% had
family history in other study. In our study was 9.5% had a family history .In
modern concept ,chronic plaque psoriasis was the most common (50%)clinical
pattern. In Siddha concept our study AZHAL KALANJAGAPADAI was common. |