| CTRI Number |
CTRI/2023/10/058341 [Registered on: 05/10/2023] Trial Registered Prospectively |
| Last Modified On: |
04/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Kaalani Ennai |
|
Scientific Title of Study
|
An open single arm single centric clinical trial to determine the effectiveness of kaalani ennai for the management of kaalani(corn foot) |
| Trial Acronym |
KE-Kaalani |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Menaka |
| Designation |
PG Scholer |
| Affiliation |
National institute of siddha |
| Address |
Room No 14
Department of Puramaruthuvam
National institue of siddha
Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7010251672 |
| Fax |
|
| Email |
menakaravi1059@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M V Mahadevan |
| Designation |
Associate Professor |
| Affiliation |
National institute of siddha |
| Address |
Head of the Department
Room No 14
Department of Pura Maruthuvam
National institute of siddha
Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9840417565 |
| Fax |
|
| Email |
puramaruthuvam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M V Mahadevan |
| Designation |
Associate Professor |
| Affiliation |
National institute of siddha |
| Address |
Head of the Department
Room No 14
Department of Pura Maruthuvam
National institute of siddha
Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9840417565 |
| Fax |
|
| Email |
puramaruthuvam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss pandithar hospital National institute of siddha |
|
|
Primary Sponsor
|
| Name |
National institute of siddha |
| Address |
Room no 14 Department of Pura Maruthuvam National institute of siddha Tambaram Sanatorium |
| 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 R Menaka |
Ayothidoss pandithar hospital |
Room No.14
Department of Pura Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Kancheepuram
TAMIL NADU |
7010251672
menakaravi1059@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L84||Corns and callosities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kaalani ennai for Kaalani |
Kaalani ennai for Kaalani
dose: sufficient quantity
frequency: daily
duration: 48 days
external application |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Presence of corn callosity Pain
Willing to give blood samples for investigation
Willing to take photograph
Willing to participate in trial and signing consent by fulfilling the condition of Proforma |
|
| ExclusionCriteria |
| Details |
History of uncontrolled Diabetes
History of Rheumatoid arthritis
History of Peripheral neuropathy
History of foot ulceration
History of taking oral steroid
History of Hansen’s disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The therapeutic effectiveness of Kaalani ennai for the management of pain will be determined by Visual analogue scale & quality of life will be monitored by EQ-5D Scale |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
14/10/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/10/2023 |
| 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 Yet Recruiting |
| 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: Siddha system of medicine provides preventive, curative and rejuvenative health care management based on the principles of pancha boodham.The siddha system of medicines are broadly classified into 32 Internal medicines & 32 External medicines of which the external medicines play a significant role in the treatment & management of various skin diseases. Intermittent pressure and friction over a long period is likely to produce a corn.It represents hyperkeratosis formed by nature to protect the sensitive part of the skin and the underlying structures from such pressure and friction.It is a conical in shape, painful hyperkeratosis appears on the soles and over the toes.The hyperkeratosis of corn gets pushed into the skin causing pressure on nerve endings which produces pain.Clinically, a corn is seen as a polished, flesh coloured and circumscribed papule. According to siddha literature corn is caused by increased friction of foot without the usage of foot wear, piercing foot by thorns and walking through the coarse stones. Now days there is an increasing number of cases of Kaalani(corn foot). I had chosen this Kaalani Ennai preparation for treatment of kaalani(corn foot).ThisKaalani Ennai contains Gowri padanam (Arsenic penta sulfide), Castor oil, Cow’s butter.This formulation is indicated for the treatment of kaalani (Corn foot) .This Ennai may be heal the corn by removing the hyperkeratosis of the skin. OBJECTIVE: To determine the therapeutic effectiveness of Kaalani Ennai for the assessment of pain by Visual analogue scale and quality of life by EQ-5D Scale. STUDY DESIGN: An open non randomised clinical trial with a total of 10 diagnosed patients of kaalani(corn foot) reporting at ayothidoss pandithar hospital national institute of siddha will be enrolled in the study.patients having History of uncontrolled Diabetes, Rheumatoid arthritis, Peripheral neuropathy, foot ulceration, taking oral steroid, Hansen’s disease will be excluded. The trial medicine Kaalani ennai as external medicine will be given for 48 days. OUTCOME: The therapeutic effectiveness of Kaalani ennai for the management of pain will be determined by Visual analogue scale and quality of life will be monitored by EQ-5D Scale.
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