CTRI Number |
CTRI/2018/07/014869 [Registered on: 13/07/2018] Trial Registered Prospectively |
Last Modified On: |
16/07/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Siddha |
Study Design |
Other |
Public Title of Study
|
A clinical trail to study the effects of karappan kudineer chooranam (internal) and karappan ennai (external ) in patients with sattai karappan |
Scientific Title of Study
|
An open clinical study to evaluate the clinical efficacy of siddha sasthric formulation karappan kudineer chooranam (internal ) and karappan ennai (external )for the treatment of sattai karappan |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
nil |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
A AMMU |
Designation |
PG Scholar |
Affiliation |
goverment siddha medical college and hospital palayamkottai |
Address |
OP NO 7 post graduate department of kuzhanthai maruthuvam OP NO 7 post graduate department of kuzhanthai maruthuvam Tirunelveli TAMIL NADU 627002 India |
Phone |
9629847962 |
Fax |
|
Email |
madhi1493@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
D K SOUNDARA RAJAN |
Designation |
professor |
Affiliation |
goverment siddha medical college and hospital palayamkottai |
Address |
OP NO 7 post graduate department of kuzhanthai maruthuvam OP NO 7 post graduate department of kuzhanthai maruthuvam Tirunelveli TAMIL NADU 627002 India |
Phone |
9442048801 |
Fax |
|
Email |
dr.dks2012@gmail.com |
|
Details of Contact Person Public Query
|
Name |
A AMMU |
Designation |
PG Scholar |
Affiliation |
goverment siddha medical college and hospital palayamkottai |
Address |
OP NO 7 post graduate department of kuzhanthai maruthuvam OP NO 7 post graduate department of kuzhanthai maruthuvam Tirunelveli TAMIL NADU 627002 India |
Phone |
9629847962 |
Fax |
|
Email |
madhi1493@gmail.com |
|
Source of Monetary or Material Support
|
IPD and OPD government siddha medical college and hospital Palayamkottai |
Library government siddha medical college and hospital palayamkottai |
|
Primary Sponsor
|
Name |
A AMMU |
Address |
Government siddha medical college and hospital palayamkottai |
Type of Sponsor |
Other [PG scholar (stif fund)] |
|
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 |
A AMMU |
Goverment siddha medical college and hospital |
OP NO 7 post graduate department of kuzhanthai maruthuvam Tirunelveli TAMIL NADU |
9629847962
madhi1493@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutiional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
sattai karappan, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Karappan kudineer chooranam(internal)karappan ennai(external) |
3-7 years 30ml,7-12 years 60ml,twice a day (morning and evening)internally and Oil-externally. |
Comparator Agent |
not applicable |
not applicable |
|
Inclusion Criteria
|
Age From |
3.00 Year(s) |
Age To |
12.00 Year(s) |
Gender |
Both |
Details |
Patient with appropriate symptoms of intense itching erythema papules papulovesicles crusted lesion all over the body ulceration exudation constipation |
|
ExclusionCriteria |
Details |
children above 12 years scabies psoriasis secondary bacterial infection nummular dermatitis contact dermatitis seborric dermatitis furunculosis photo dermatitis neuro dermatitis |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
the therapeutic efficacy of trial drug Karappan kudineer chooranam(internal)karappan ennai (external)on Sattai karappan |
21 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Evaluation of siddha diagnostic parameters |
21 days |
|
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
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
17/07/2018 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
17/07/2018 |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="1" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
not yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The study is prospective open labeled non randomized phase 2 an open clinical study to evaluate the clinical efficacy of siddha sasthric formulation Karappan kudineer chooranam(internal) Karappan ennai (external) 3-7 years 30ml,7-12years 60ml,twice a day (morning and evening)internally and Oil-externally for 21 days in 40 patients during the trail period of 13months that will be conducted in government siddha medical college and hospital palayamkottai Tamil nadu The primary outcome will be the therapeutic efficacy of trial drug Karappan kudineer chooranam(internal) karappan ennai(external)on Sattai karappan The secondary outcome will be the evaluation of siddha diagnostic parameters |