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CTRI Number  CTRI/2017/05/008497 [Registered on: 05/05/2017] Trial Registered Retrospectively
Last Modified On: 24/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic treatment of Paralysis  
Scientific Title of Study   A COMPARATIVE CLINICO-EXPERIMENTAL STUDY TO EVALUATE EFFICACY OF VIRECHANA AND KAALA BASTI ALONG WITH SHAMANA THERAPY IN THE MANAGEMENT OF PAKSHAGHATA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Adil Rais 
Designation  Phd Scholar  
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda  
Address  Department of Panchakarma Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University JAMNAGAR GUJARAT

Jamnagar
GUJARAT
361008
India 
Phone  7060272769  
Fax    
Email  adil.rais13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Adil Rais 
Designation  Phd Scholar  
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda Jamnagar Gujarat 
Address  Department of Panchakarma Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University JAMNAGAR GUJARAT

Jamnagar
GUJARAT
361008
India 
Phone  7060272769  
Fax    
Email  adil.rais13@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anup B Thakar 
Designation  Professor 
Affiliation   
Address  Department of Panchakarma Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat
Department of Panchakarma Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9978403254  
Fax    
Email  anup_thakar@yahoo.com  
 
Source of Monetary or Material Support  
Institute for Post Graduate Teaching and Research in Ayurveda Jamnagar Gujarat 
 
Primary Sponsor  
Name  IPGT RA GAU JAMNAGAR GUJARAT 
Address  Department of Panchakarma IPGT RA GAU JAMNAGAR GUJARAT 
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 
adil rais  OPD no 22 IPD Department of Panchakarma   Department of Panchakarma Institute for Post Graduate Teaching and Research in Ayurveda
Jamnagar
GUJARAT 
7060272769

adil.rais13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  paralysed patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  kaala basti with shamana therapy  kaala basti will be given for 16 days followed by shamana drug masha baladi kwatha for one month 
Comparator Agent  shamana drug   shamana drug masha baladi kwatha for one month 
Intervention  virechana followed by shamana drug  patients in this group will be given classical virechana karma followed by shamana drug in which masha baladi kashaya 100 ml twice a day 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  diagnosed cases of pakshaghata
yogya for virechana and basti karma 
 
ExclusionCriteria 
Details  degenerative lesions
intracranial infection
intra cranial spae ocupying lesion 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
to improve the disability produced by pakshaghata  7 to 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
to improve quality of life of patients and assess signs and symptoms after four weeks  four weeks 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/02/2016 
Date of Study Completion (India) 10/10/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

After careful review of the results obtained during the study, following conclusions can be drawn with respect to Pakshaghata and its clinical management, Pharmacological and Ayurgenomics study:

Ø  Peak incidence of the disease was after fifth decade establishing the degenerative aspect of Pakshaghata.

Ø  Physical and mental stress was the most common causative factor noticed. Disturbed biological clock associated with professions like security guards, drivers, farmers and fishermen were found to be more prone for development of Pakshaghata. Most of the patients affected by the disease were of Vata-paittika prakriti. Addiction of tobacco (chewing and smoking) was a prominent finding in most of the patients.

Ø  Maximum patients registered had a history of infarct while hemorrhagic cases were lesser in number. Most common presenting complain was weakness of the motor system involving upper and lower limbs followed by impaired speech and facial weakness. Minimal sensory involvement was seen. Most common associated features were vertigo and headache.

Ø  Group A (Virechana followed by Shamana) and Group B (Basti followed by Shamana) showed comparatively more improvement in clinical manifestations as compared to only Shamana (Masha Baladi Kwatha) treatment, i.e. Group C. These changes were statistically significant.

Ø  Basti provided relatively better improvement in the quality of life and in the management of higher mental functions. Basti was found to be more effective in management of Infarct cases while hemorrhagic cases were better addressed by Virechana.

Ø  Virechana followed by Shamana, managed Motor functions better than Basti followed by Shamana. Prognosis was better in the patients of younger age group and lesser chronicity.

Ø  Safe application of Basti and Virechana was demonstrated through animal study. No pathological findings were reported in the histopathological study.

Ø  Virechana and Basti showed lipid lowering effects after pharmacological study. Findings were more prominent in Basti group which was statistically significant.


 

Selected samples of Virechana and Basti were analyzed for Gene expression changes.

Ø  Many genes and signaling pathways were differentially expressed which had a significant role in relation to Stroke. This differential expression was significant as the first stride to establish Panchakarma therapies at a molecular level.

Ø  More protein translation functions were expressed in Basti samples than Virechana.

Ø  Ayurgenomics study also showed the importance of Snehapana and Samsarjana krama during Shodhana due to varied expression at different stages which actually justifies the extreme importance laid on management during Shodhana operations and thereafter.

Ø  This differential expression at Genomic levels may be a significant lead and pave the way for future studies for more extensive research to find a confirmatory relationship between Stroke management through Panchakarma therapies like Basti and Virechana.

Ø  Some pathways related to other diseases like Cancer, Alzheimer’s, Parkinson’s disease, Rheumatoid Arthritis etc. were also differentially expressed after Virechana and Basti, so these can also be considered for similar research in future.

ü  Finally, the Null hypothesis (H0) which stated that-Shamana after Virechana and Shamana after Basti and only Shamana are equally effective in Pakshaghata, was rejected.

ü  Alternate hypothesis (H2) stating that -Shamana after Basti is more effective in the management of Pakshaghata than shamana after Virechana or only Shamana, was accepted.

Therefore, we may conclude that Shamana after Basti in Pakshaghata was comparatively more effective considering the Clinical, Pharmacological and Ayurgenomics parameters.

 
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