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CTRI Number  CTRI/2012/04/002583 [Registered on: 18/04/2012] Trial Registered Retrospectively
Last Modified On: 21/03/2012
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical and experimental study to compare the four types of virechana karma (Purgation Therapy) i.e Anulomana-By Haritaki, Sramsana-By Aragwadha, Bhedana-By Katuki,Rechana-By Trivrit and their efficacy in the management of Ekakushtha (Psoriasis). 
Scientific Title of Study   A Clinico-Experimental Study on Four Types Of Virechana Karma in Ekakushtha (Psoriasis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vikram Kumar 
Designation  Ph D Scholar 
Affiliation  Institute for Post Graduate Teaching & Research in Ayurveda 
Address  Department of Panchakarma Institute for Post Graduate Teaching & Research in Ayurveda Gujarat Ayurved University Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  919574937714  
Fax    
Email  vikramkumar83@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anup B Thakar 
Designation  Associate professor 
Affiliation   
Address  Department of Panchakarma Institute for Post Graduate Teaching & Research in Ayurveda Gujarat Ayurved University Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Anup B Thakar 
Designation  Associate professor 
Affiliation   
Address  Department of Panchakarma Institute for Post Graduate Teaching & Research in Ayurveda Gujarat Ayurved University Jamnagar

Junagadh
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Source of Monetary or Material Support  
Institute for Post Graduate Teaching & Research in Ayurveda, Gujarat Ayurved University Jamnagar-361008. 
 
Primary Sponsor  
Name  I P G T R A 
Address  Institute for Post Graduate Teaching & Research in Ayurveda, Gujarat Ayurved University Jamnagar-361008. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikram Kumar  Department of Panchakarma, IPGT & RA Hospital Jamnagar  Institute for Post Graduate Teaching & Research in Ayurveda, Gujarat Ayurved University Jamnagar-361008.
Jamnagar
GUJARAT 		 919574937714

vikramkumar83@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee I P G T & R A Jamnagar.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients suffering from psoriasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cassia fistula Linn   About 25 -50gms of Cassia fistula Linn fruit pulp is taken and hot effusion is prepared.About 150-250ml is administered orally once for Virechana (purgation). Duration:15-20 days. 
Comparator Agent  Operculina turpethum Linn  About 10-30gms of Operculina turpethum Linn root coarse powder is taken and decoction is prepared.About150-250ml is administered orally once for Virechana(purgation). Duration:15-20 days. 
Comparator Agent  Picrorhiza kurroa Royle ex Benth  About 10 -30gms of Picrorhiza kurroa Royle ex Benth rhizome coarse powder is taken and decoction is prepared.About 150-250ml is administered orally once for Virechana (purgation). Duration:15-20 days. 
Intervention  Terminalia chebula Retz   About 25 -50gms of Terminalia chebula Retz fruit coarse powder is taken and decoction is prepared.About 150-250ml is administered orally once for Virechana (purgation). Duration:15-20 days.  
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients with all forms of Psoriasis who are clinically fit to undergo Virechana procedure.
2.Age- 17 to 60 years
3.Sex- Both sexes
4.Patients having Madhyma Koshtha

 
 
ExclusionCriteria 
Details  1.Clinically unfit for Virechana.
2.Age <17yrs & >60yrs.
3.Patients having Mridu & Krura Koshtha.
4.Pregnant lady
5.Any other serious systemic illness
6.Patient not willing for treatment.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of Virechana
-Based on Vaigiki shuddhi , Maniki shuddhi, Laingiki shuddhi and Antiki shuddhi.
-Time of administration of Virechana drug & time of onset of first vega.
-Total duration of Virechana.
-Effect of four types of Virechana on Hematological and bio-chemical parameters.
 		 Assessment will be done during the time of Virechana. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improvements in signs and symptoms of Psoriasis.
2. Improvements in Dermatology Life Quality Index.
3.Improvements in Psoriasis Area Severity Index (PASI) score. 		 Assessments will be done before and after treatment and changes will be noted.  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 1/ Phase 2 
Date of First Enrollment (India)   18/07/2011 
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="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The purpose of the study is
1. To compare the four types of Virechana Karma ( Purgation therapy) i.e Anulomana, Sramsana, Bhedana and Rechana in patients of Ekakushtha (Psoriasis).
2. To compare the efficacy of four types of Virechana Karma on Ekakushtha (Psoriasis).

Method of research:  Patients of psoriasis will be selected based on inclusion & exclusion criteria from O.P.D & I.P.D of I.P.G.T & R.A Hospital, Jamnagar, irrespective of religion, sex, occupation, cast etc. They will be randomly divided into 4 groups, Group A (Anulomana group), Group B (Sramsana group), Group C (Bhedana group) and Group D (Rechana group).

Interventions

Group A

Deepana & Pachana with Trikatu Choorna 2gm b.d for 2 days.

Snehapana with Murchita goghrita till samyak snigdha lakshanas

Abhyanga & Ooshmasweda for 3 days

Virechana with Anulomana drug (Hareetaki-Terminalia chebula Retz)

Samsarjana krama.           

 

Group B

Deepana & Pachana Trikatu Choorna 2gm b.d for 2 days

Snehapana with Murchita goghrita till samyak snigdha lakshanas

Abhyanga & Ooshmasweda for 3 days

Virechana with Sramsana drug (Aragwadha-Cassia fistula Linn)

Samsarjana krama.

 

Group C

Deepana & Pachana Trikatu Choorna 2gm b.d for 2 days

Snehapana with Murchita goghrita till samyak snigdha lakshanas

Abhyanga & Ooshmasweda for 3 days

Virechana with Bhedana drug (Katuki-Picrorhiza kurroa Royle ex Benth)

Samsarjana krama.

 

Group D

Deepana & Pachana Trikatu Choorna 2gm b.d for 2 days

Snehapana with Murchita goghrita till samyak snigdha lakshanas

Abhyanga & Ooshmasweda for 3 days

Virechana with Rechana drug (Trivriti-Operculina turpethum Linn)

Samsarjana krama.

Selection of Drug:

Trikatu choorna for Deepana & Pachana

Murchita goghrita for snehapana.

Murchita tila taila for abhyanga

Haritaki (Terminalia chebula Retz) fruit – for Anulomana

Aragwadha (Cassia fistula Linn) fruit pulp – for Sramsana

Katuki (Picrorhiza kurroa Royle ex Benth) rhizome – for Bhedana

Trivrit (Operculina turpethum Linn) root – for Rechana

Dose:  

Haritaki - 25-50gms

              Aragwadha – 25 -50gms

              Katuki – 10-30gms

              Trivrit – 10-30gms

Kwatha (Decoction) of above drugs will be prepared by the classical method and used for Virechana. Aragwadha will be administered in the form of Phanta (Hot effusion).

Duration of study: 15-20 days

Laboratory investigations:

  1. Routine Blood, Urine and Stool investigations before & after treatment will be done.
  2. Biochemical investigations - Blood Sugar, Lipid profile, Serum Bilirubin, Total Proteins, LFT, RFT, and Serum electrolytes will be done before & after treatment

Assessment Criteria:

Assessement of Virechana

-          Shuddhi will be assessed based on Vaigiki shuddhi (number of vegas), Maniki shuddhi (quantity of faeces), Laingiki shuddhi (signs and symptoms of proper Virechana) and Antiki shuddhi ( malanta, pittanta, kaphanta & vatanta).

-          Time of administration of Virechana drug & time of onset of first vega.

-          Total duration of Virechana.

-          Haematological, urine, stool & biochemical investigations will be done before treatment & after treatment.

                                                  

Assessment of response of therapy on Psoriasis

The improvement provided by different types of Virechana will be assessed on the basis of relief in signs & symptoms. All the signs & symptoms will be assigned scores depending upon their severity to assess the effect objectively.

 
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