| CTRI Number |
CTRI/2019/07/020422 [Registered on: 29/07/2019] Trial Registered Prospectively |
| Last Modified On: |
27/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
To know the symptoms of karumperunoi in siddha literature and comparision with modern diagnostic Atopic dermatitis |
|
Scientific Title of Study
|
A study on Diagnostic methodology and symptomatology of "Karum perunoi"(Krishna Kuttam) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B Muthu karthikeyan |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of NoiNaadal,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8903441419 |
| Fax |
|
| Email |
b.m.k.keyan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Elansekaran |
| Designation |
Associate professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of NoiNaadal,
National Institute of Siddha,
Tambaram Sanatorium,
Chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962536907 |
| Fax |
|
| Email |
sekarnis78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Muthu karthikeyan |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of NoiNaadal,
National Institute of Siddha,
Tambaram Sanatorium,
chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8903441419 |
| Fax |
|
| Email |
b.m.k.keyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha, Tambaram Sanatorium, Chennai, 600047 |
|
|
Primary Sponsor
|
| Name |
national institute of siddha |
| Address |
National Institute of Siddha, Tambaram Sanatorium, Chennai, 600047 |
| 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 B Muthu karthikeyan |
National Institute of Siddha |
Room No 5, Out Patient Department, Ayothidoss Pandithar Hospital, National Institute of Siddha,
Tambaram Sanatorium,
Chennai-47
Kancheepuram
TAMIL NADU |
8903441419
b.m.k.keyan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pavalaveera chunnam |
Dose 100mg - two time / day
Adjuvant buttermilk
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Extremely pruritic
2. Eczematous eruption
3. lichenification on flexural area popliteal & cubital fossae
|
|
| ExclusionCriteria |
| Details |
1.Secondary infections
2.Impetigo
3.Severe systemic illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Establishing the relevance of Sage Yugi symptomatology about Karumperu noi with that of present day patient sample |
2 visits |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Arriving at on interpretation of Karumperu noi its Siddha pathophysiology and symptomatology with reference to modern pathological concepts of dermatitis
findings of Udal Vaagu and Kuttra Vaagu formulation of line of treatment for the condition of Karumperu noi |
2 visits |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2019 |
| 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
|
this article will be publish after finishing. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Siddha system of medicine is one of the ancient system of medicine. In siddha system of medicine had 4448 types of disease divided by the great saint’s 18 Siddhars. KARUMPADAI NOI is one of among 4448. In this study we have to briefly explain and diagnostic method by system and we have to compare with Modern system of medicine. my aim of study is proper diagnosis and treatment. its characterised by Extremely pruritic, Eczematous eruption, Lichenification on flexural area popliteal & cubital fossae. The signs and symptoms of KARUMPERU NOI mentioned in the Siddha literature may be correlated with ATOPIC DERMATITIS in modern disease classification. |