| CTRI Number |
CTRI/2020/04/024586 [Registered on: 13/04/2020] Trial Registered Prospectively |
| Last Modified On: |
03/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Purgation is given with trivrit triphala and danti in liquid form to see the efficacy of drugs in the psoriasis |
|
Scientific Title of Study
|
Effectiveness of virechana karma with dantyadi yoga in the management of eka kushta(psoriasis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Dhiman |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hopital |
| Address |
Department of Panchakarma
SDM College of Ayurveda and Hospital
Thanniruhalla
hassan
Hassan
KARNATAKA
573201
India |
| Phone |
7411292449 |
| Fax |
|
| Email |
drpriyanka.ayush@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BA Lohith |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hopital |
| Address |
Deparment of Panchakarma
SDM College of Ayurveda and Hospital
Thanniruhalla
hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9886749168 |
| Fax |
|
| Email |
drlohithpk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Dhiman |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hopital |
| Address |
Department of Panchakarma
SDM College of Ayurveda and Hospital
Thanniruhalla
hassan
Hassan
KARNATAKA
573201
India |
| Phone |
7411292449 |
| Fax |
|
| Email |
drpriyanka.ayush@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
Thanniruhalla, hassan (573201) karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Dhiman |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla, hassan (573201) karnataka |
| Type of Sponsor |
Other [self] |
|
|
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 Priyanka Dhiman |
SDM College of Ayurveda and Hospital |
Dept of panchakarma
thaniruhalla
hassan(573201)
Hassan
KARNATAKA |
7411292449
drpriyanka.ayush@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L409||Psoriasis, unspecified, (2) ICD-10 Condition: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Purgation with danti(baliospermum montanum),triphala(i.e amalaki-emblica officinalis,bibhitaki-terminalia bellirica,haritaki-terminalia chebula) and trivrit(operculina turpethum). |
1. Virechana medicine dose - (liquid form) 30-100 ml
2. Route of administration - oral route
3. Total duration of treatment 13 to 21 days.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are fit for virechana karma
2.Between the age group of 18-60 years
3.Patients who are willing to participate and sign informed consent form
4.Patient who are fulfilling all the diagnostic criteria |
|
| ExclusionCriteria |
| Details |
1.Patients with complications of psoriasis
2.Cases of diabetes mellitus, hypertension, HIV, HBsAg, carcinoma
3.Subjects with impaired cardiac function,impaired hepatic function, impaired hepatic function
4.Signs of systemic infections
5.Pregnant women and lactating mother |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effectiveness will be evaluated by the relief seen in sign and symptoms |
outcome will be assessed after 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2020 |
| Date of Study Completion (India) |
17/05/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
17/05/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study is to evaluate the effectiveness of Virechana karma with Dantyadi yoga in the management of Ekakushta. Hypothesis Null Hypothesis- There is no significant effect of Virechana karma with dantyadi yoga in the management of Ekakushta. Alternative Hypothesis- Virechana karma with Dantyadi yoga have significant effect in the management of Ekakushta. |