| CTRI Number |
CTRI/2017/08/009584 [Registered on: 31/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
30/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To prove Vyadhipratyanika Chikitsa with Patolamuladi Kashaya in Vicharchika |
|
Scientific Title of Study
|
An open label non randomized clinical study to validate the concept of Vyadhipratyanika Chikitsa with Patolamuladi Kashaya in Vicharchika |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amaresh Kar |
| Designation |
Post graduate sholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka |
| Address |
Department of Ayurved Samhita and Siddhanta, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
08088983849 |
| Fax |
|
| Email |
amreshkumar786.ak96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mallika KJ |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka |
| Address |
Department of Ayurved Samhita and Siddhanta, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
09844183769 |
| Fax |
|
| Email |
drmallikakj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mallika KJ |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka |
| Address |
Department of Ayurved Samhita and Siddhanta, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
09844183769 |
| Fax |
|
| Email |
drmallikakj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM Road, Thanniruhalla, Hassan - 573201, Karnataka |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
Hassan
Karnataka |
| 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 |
| Dr Amaresh Kar |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
OPD no: 3 (Kayachikitsa special)
Devision of Kayachikitsa main),
for consultant of Samhita Siddhanta.
Hassan
KARNATAKA |
08088983849
amreshkumar786.ak96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Vicharchika (Eczema), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patolamuladi Kashaya |
Patolamuladi Kashaya given in a dose of 50 ml mixed with equal quantity of like warm water morning time in empty stomach for 6 days in Asravi Vicahrchika |
| Intervention |
Patolamuladi Kashaya |
Patolamuladi Kashaya given in a dose of 50 ml mixed with equal quantity of like warm water morning time in empty stomach for 6 days in Sravi Vicahrchika |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
i. Diagnosed cases of Sravi-AsraviVicharchikaVis a Vis Eczema based on above criteria.
ii. Either gender between age group 15-65 years irrespective of chronicity
iii. Chronicity less than (<) 5 years.
iv. Patients those who are ready to give their consent sign
|
|
| ExclusionCriteria |
| Details |
i. Patient other than Vicharchika.Patient suffering from other systemic disease or suffering from any chronic disease like Diabetic mellitus,HIV or HBSAG positive
ii. Pregnant woman
iii. Patient these who are taking any immunosuppressant medications.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To validate the concept of Vyadhipratyanika chikitsa in Vicharchika using Patolamuladi Kashaya |
6 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate Vyadhipratyanika chikitsa in Sravi Vicharchika and Asravi Vicharchika |
6 days |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/12/2016 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Vyadhipratyanika chikitsa siddhanta (disease specific treatment) is the main line of treatment for the disease like kushta and prameha as these treatment is explained in general by acharyas as the doshapryatanika chikita don’t have much role in treatment. In these conditions the symptoms does not show either according to dosha or dushya here lakshna appear according to vyadhi samprapti. So here a study has been taken to validate the concept of vyadhipryanika chikista siddhanta in sravi asravi vicharchika using Patolamuladikashya for a 6 days study explained by charaka in kushta chikitsa 7th chapter sloka number 62 to 64 .
|