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CTRI Number  CTRI/2018/08/015534 [Registered on: 30/08/2018] Trial Registered Prospectively
Last Modified On: 03/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study of application of Jalauka(Medicinal Leech) with and without Vamana Karma(Therapeutic Emesis) in the Management of Mandal Kushtha(Psoriasis).  
Scientific Title of Study   “An Open Randomized Comparative Clinical Study of Vamanottara Jalaukavacharana and Jalaukavacharana in the Management of Mandal Kushtha w.s.r. to 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 Pravesh Srivastava 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda 
Address  PG Department of Panchkarma, National Institute of Ayurveda,Madhav Vilas Palace, Jorawar Singh Gate,Jaipur,Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9340901447  
Fax    
Email  ayurpravesh064@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gopesh Mangal 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda 
Address  PG Department of Panchkarma, National Institute of Ayurveda,Madhav Vilas Palace, Jorawar Singh Gate,Jaipur,Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  8619849011  
Fax    
Email  gmangal108@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pravesh Srivastava 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda 
Address  PG Department of Panchkarma, National Institute of Ayurveda,Madhav Vilas Palace, Jorawar Singh Gate,Jaipur,Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9340901447  
Fax    
Email  ayurpravesh064@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Madhava vilas palace,Jorawar Singh Gate, Amer road, Jaipur-302002, Rajasthan 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Madhav Vilas Palace, Jorawar Singh Gate,Jaipur,Rajasthan 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Pravesh Srivastava  PG Department of Panchkarma, National Institute of Ayurveda,Madhav Vilas Palace, Jorawar Singh Gate,Jaipur,Rajasthan 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pravesh Srivastava  PG Department of Panchkarma, OPD Room no 2, National Institute of Ayurveda  Madhav Vilas Palace, Jorawar Singh Gate,Jaipur,Rajasthan
Jaipur
RAJASTHAN 
9340901447

ayurpravesh064@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L40-L45||Papulosquamous disorders, (2) ICD-10 Condition: L409||Psoriasis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A  Vamana Karma followed by Jalaukavacharana will be done in 15 patients. . Vamana procedure 1. Deepana, Pachana with Panchakol Choorna (3 gm) twice a day before food till appearance of Nirama lakshana. 2. Snehapana with Go-Ghrita for 3-7 days as per Kostha will be done till the appearance of Samyaka Snigdha Lakshana. 3. Sarvanga Abhyanga by Dashamoola Taila and Sarvanga Swedana by the Dashamoola Kwatha will be done for 2 days. 4. Vamana will be done by administrating Vamaka Yoga 5. After Vamana Karma, Dhoompana will be done followed by Samsarjana Karma as per the type of Shuddhi. Jaluakavacharan procedure 1. Affected part will be made free from any ointment, application of local Swedan (Nadi Swedan ) will be done. 2. Patient will be given 4 seating of Jalaukavacharana one per week. 3. Six Jalauka will be applied (2 on upper extremities, 2 on lower extremities, 2 on trunk and head region) and Jalauka will be reused only for the same patient. 4. Removal of Jalauka, Vamana of Jalauka, labelling of Jaluaka container will be done in proper way. 5. Dressing up will be done after rubbed with honey and cotton bandage will be used.  
Intervention  Group B  Only Jalaukavacharana will be done in 15 patients. Jaluakavacharan procedure 1. Affected part will be made free from any ointment, application of local Swedan (Nadi Swedan ) will be done. 2. Patient will be given 4 seating of Jalaukavacharana one per week. 3. Six Jalauka will be applied (2 on upper extremities, 2 on lower extremities, 2 on trunk and head region) and Jalauka will be reused only for the same patient. 4. Removal of Jalauka, Vamana of Jalauka, labelling of Jaluaka container will be done in proper way. 5. Dressing up will be done after rubbed with honey and cotton bandage will be used.  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details 
a) Patients between 18 to 60 years of age.
b) Patients with the classical features of Mandal Kushtha (psoriasis).
c) Patients not taking any other medicine for Mandal Kushtha (psoriasis).
d) Patients fit for Vamana and Jalaukavacharana.
e) Patients willing to sign consent form for trial.
 
 
ExclusionCriteria 
Details 
1. Pregnant women and lactating mothers.
2. Patients suffering from systemic disorders as Cardiac Problem, Uncontrolled Diabetes mellitus, Uncontrolled Hypertension, Paralysis, Malignancy, HIV, HBsAg, Leprosy.
3. Patients unfit for Vamana karma and Jalaukavacharana.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of changes in specific signs and symptoms of Mandal Kushtha (psoriasis).  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
A Any adverse effect in the values of hematological test and in clinical signs and symptoms.  60 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)
Modification(s)  
10/01/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  
None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Introduction:

Psoriasis is chronic inflammatory skin disorder clinically characterized by erythematous, sharply demarcated papules and rounded plaques. Since characteristics features of psoriasis are much closer to Mandal Kushtha hence Mandal Kushtha can be compared with psoriasis.  Mandal Kushtha is Kapha predominant disease. The etiology of Mandal Kushtha can be understood on the basis of general etiology of Kushtha. Swetarakta (faint reddish white), Utsannamandalam (raised patches), Sthiram (stable), Snigdham (unctous), Annyonyasansaktm (patches joined with each other) are important clinical features of Mandal Kushtha. Although there are advancements in the management of psoriasis still it is challenge to treat due to recurrent nature. Prevalence of psoriasis ranges between 0.09% and 11.5% . Prevalence in India is 0.44 – 2.2%, with average incidence of 2.2%.As mentioned by Acharya Charaka â€œBahudosha Samsodhya……..” . There is a need of study to rule out the effective, safer and economical methods of Dosha Sodhana for the management of Mandal Kushtha. There is also need to evaluate the comparative efficacy of different types of Sodhana Karma based on the predominance Dosha for the better management of diseases.

Materials and Methods:

30 patients suffering from Mandal Kushtha (psoriasis) attending OPD and IPD section of NIA, Jaipur (Raj) fulfilling the inclusion criteria of the study were randomly selected, irrespective of religion, occupation and socio-economic status. Patients were randomly divided into two groups (15 patients in each group). In Group A Vamana Karma followed by Jalaukavacharana was done in 15 patients and in Group B only Jalaukavacharana was done in 15 patients. 

Vamana procedure - First of all Deepana, Pachana with Panchakol Choorna (3 gm) twice a day before food till appearance of Nirama Lakshana was givenSnehapana with Go-Ghrita for 3-7 days as per Kostha was done till the appearance of Samyaka Snigdha Lakshana. Sarvanga Abhyanga by Dashamoola Taila and Sarvanga Swedana by the Dashamoola Kwatha was done for 2 days. Vamana was induced by administrating Vamaka Yoga. After Vamana Karma, Dhoompana was done followed by Samsarjana Karma as per the type of Shuddhi

Jaluakavacharan procedureAffected part were made free from any ointment, application of local Swedana (Nadi Swedana ) was done. Patients were given 4 seating of Jalaukavacharana once per week. 6 Jalauka was applied (2 on upper extremities, 2 on lower extremities, 2 on trunk and head region) and Jalauka was be reused only for the same patient. Removal of Jalauka, Vamana of Jalauka, labelling of Jaluaka container was done in proper way. Dressing up was done and cotton bandages were used.

TRIAL DRUGS- Deepan Paachan drugs-Panchakol Choorna(A.H.Su 6/166). Drugs of Jeemutak Yoga for Vamana Karma. Vamanopag drugs-   Madhuyashtiphanta (Glycyrrhiza glabra).

PASI score was used as the objective parameter. Assessment was done on the basis of PASI and Ayurveda parameter  before treatment, after treatment and during last follow up.

Result:

Wilcoxan Rank Sum test and Mann-Whitney test were used for the statistical analysis.

Effect on Mandal Roopa:

The study shows that Group A (Vamana Karma followed by Jalauakavacharana) provided very significant (p<0.05) results in Mandal Roopa with percentage of relief by 20.35% after treatment and on follow-up, it shows very significant relief of 26.54% with p value (p<0.05) in within group comparison. Group B (Jalauakavacharana) provided relief by 2.43% in Mandal Roopa after treatment which is statistically not significant (p>0.05) and on follow-up also, it shows non-significant result with p value (p>0.05) with relief of only 8.13%. Thus both group have efficacy on Mandal Roopa but Group A patient shows marked improvement. Inter group comparison shows that statistically there is no any significant between Group A and Group B. But we can found marked difference in mean rank sum of both groups. Mean rank of Mandal Roopa (18.10) in Group A is greater than that of mean rank of Mandal Roopa (12.90) in Group B.

Effect on Kandu:

Present study shows that in group A (Vamana Karma followed by Jalauakavacharana) provided extremely significant variation with percentage of relief by 48.71% after treatment In group B (Jalauakavacharana) provided extremely significant variation with percentage of relief by 45.45% after treatmen

Hence both the group has shown extremely significant effect in the Kandu parameter when compared within group.

Inter group comparison shows that statistically there is no any significant between Group A and Group B. Mean rank of Kandu (18.00) in Group A is greater than that of mean rank of Kandu (13.00) in Group B. Thus, based on mean rank we can say that Group A is slightly more effective than Group B on reducing the Kandu in psoriasis patients.

Effect on Chinta:

Present study shows that Group A (Vamana Karma followed by Jalauakavacharana) provided extremely significant (p<0.001) results in Chinta with percentage of relief by 39.91% after treatment and on follow-up, it showed extremely significant (p<0.001) results with relief of 45.92%. Group B (Jalauakavacharana) provided relief by 10.75% in Chinta after treatment which is statistically not significant (p>0.05) and on follow-up also, it shows non-significant result with p value (p>0.05) with same relief of only 10.75%.

Inter group comparison shows that there is very significant variation in both groups after treatment in the parameter of Chinta (p<.001). Group A is found more effective than Group B.  Stress is a common trigger for psoriasis disease.

 

Effect on PASI:

This study shows that after treatment on group A (Vamana Karma followed by Jalauakavacharana) showed very significant (p=0.001) results in PASI Score with percentage of relief by 46.75% after treatment and on follow-up also, it shows very significant relief of 56.38% with p value (p=0.001). 

Thus, within-group comparison shows that both the group have significant improvement on PASI.

Whereas intergroup comparison shows that there is significant variation in both groups after treatment in the parameter of PASI Score. 

The Group A (mean rank 20.07) has shown significant decrease in the PASI Score than group B (mean rank 10.93).

 

Conclusion:

Group A (Vamana Karam followed by Jalaukavacharana) is more effective than Group B, thus null hypothesis is rejected and alternative hypothesis is accepted.

 


 
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