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).
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Scientific Title of Study
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“An Open Randomized Comparative Clinical Study of
Vamanottara Jalaukavacharana and Jalaukavacharana in the Management of Mandal Kushtha w.s.r. to Psoriasisâ€
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Trial Acronym |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
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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 |
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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 |
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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 |
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Source of Monetary or Material Support
|
National Institute of Ayurveda
Madhava vilas palace,Jorawar Singh Gate, Amer road, Jaipur-302002, Rajasthan |
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Primary Sponsor
|
Name |
National Institute of Ayurveda |
Address |
Madhav Vilas Palace, Jorawar Singh Gate,Jaipur,Rajasthan |
Type of Sponsor |
Government medical college |
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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 |
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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 |
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Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee, National Institute of Ayurveda |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
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Health Type |
Condition |
Patients |
(1) ICD-10 Condition: L40-L45||Papulosquamous disorders, (2) ICD-10 Condition: L409||Psoriasis, unspecified, |
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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.
|
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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.
|
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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 |
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Secondary Outcome
|
Outcome |
TimePoints |
A Any adverse effect in the values of hematological test and in clinical signs and symptoms. |
60 days |
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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)?
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Brief Summary
Modification(s)
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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 “Bahudosha 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 given. Snehapana 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 procedure- Affected 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. |