| CTRI Number |
CTRI/2020/10/028185 [Registered on: 01/10/2020] Trial Registered Prospectively |
| Last Modified On: |
25/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of kankarishta in the management of Eczema |
|
Scientific Title of Study
|
A Pharmaceutico Analytical And Clinical Study of Kankaristha W.S.R to Vicharchika (ECZEMA) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr somit mandal |
| Designation |
PG Scholar |
| Affiliation |
Shubhdeep Ayurveda Medical college & P.g institute |
| Address |
Rasashtra and bhaishajya kalpana department G-40 Gram datoda, khandwa road
Indore
MADHYA PRADESH
451002
India |
| Phone |
8109410554 |
| Fax |
|
| Email |
somitm890@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhilesh shrivastava |
| Designation |
Professor |
| Affiliation |
Shubhdeep Ayurveda Medical college & P.g institute |
| Address |
Rasashtra and bhaishajya kalpana department G-40 Gram datoda, khandwa road
Indore
MADHYA PRADESH
451002
India |
| Phone |
9993281713 |
| Fax |
|
| Email |
drshrivastava.akhilesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhilesh shrivastava |
| Designation |
Professor |
| Affiliation |
Shubhdeep Ayurveda Medical college & P.g institute |
| Address |
Rasashtra and bhaishajya kalpana department G-40 Gram datoda, khandwa road
Indore
MADHYA PRADESH
451002
India |
| Phone |
9993281713 |
| Fax |
|
| Email |
drshrivastava.akhilesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shubhdeep Ayurveda Medical College and Hospital Indore |
|
|
Primary Sponsor
|
| Name |
shubhdeep ayurved medical college indore |
| Address |
Room no 40 Shubhdeep Ayurveda Medical college Hospital, Indore |
| Type of Sponsor |
Private medical college |
|
|
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 |
| somit mandal |
shubhdeep ayurveda medical college and hospital |
Rasashtra and bhaishajya kalpana department G-40 Gram datoda, khandwa road
Indore
MADHYA PRADESH |
8109410554
somitm890@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: L259||Unspecified contact dermatitis, unspecified cause, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
kankarishta |
kankarishta 20 ml with 20 ml water after meals BD for 30 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patients presenting with clinical features of vicharchika (eczema)
2.patients willing to participate in trial. |
|
| ExclusionCriteria |
| Details |
1. patients associated with other systemic diseases.
2.patients associated with other type of systemic disease.
3. systemic disease including D.M,HIV and others. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
reviewing patients on the following symptoms
releif in kandu
releif in pidika
releif in vaivarnya
releif in shrava
releif in rukshta |
30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
nil |
|
|
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)
|
10/10/2020 |
| 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="0"
Months="6"
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
|
Ayurveda is the science of life , It is the ancient medical science. Which
existed in human societies before the application of modern science to health .
Ayurveda date back an estimated 5000 years and is widely considered to
be the oldest form of the health care in the world. The unique feature of ayurveda
is that gives importance to the holistic treatment .Bhaishajya kalpana,
the branch of ayurveda which deals with the pharmaceutical preparation
of herbs & herbo-minerals. In charak samhita, It has been mentioned
that khadir is very useful in any type of kustha. Kankaristha
which contain khadir is most effective in the treatment of kustha
. It contain 5 to 10% of self-generated alcohol, so that we can stored for long
time without losing their potency, instead there is increase in the potency as
these preparation becomes old. It possesses ashukari guna that it works
at the level of dosha and dhatus.
|