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CTRI Number  CTRI/2018/06/014628 [Registered on: 28/06/2018] Trial Registered Prospectively
Last Modified On: 29/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Study on the Efficacy of oil enema and Patra Pinda Swedana in the Management of Sciatica 
Scientific Title of Study   A Comparative Clinical Study on the Efficacy of Sahachara Taila Matra Basti and Patra Pinda Swedana in the Management of Gridhrasi w.s.r. to Sciatica 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Ayurveda PG Thesis  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RAM PRABODH CHAUDHARY 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda 
Address  Dept. Of Panchkarma, National Institute of Ayurveda,

Jaipur
RAJASTHAN
302002
India 
Phone  9079823056  
Fax    
Email  ramprabodhchaudhary7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gopesh Mangal 
Designation  Assisstant professor and head(i/c) 
Affiliation  National Institute of Ayurveda 
Address  Dept. Of Panchkarma, National Institute of Ayurveda,

Jaipur
RAJASTHAN
302002
India 
Phone    
Fax    
Email  gmangal108@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gopesh Mangal 
Designation  Assisstant professor and head(i/c) 
Affiliation  National Institute of Ayurveda 
Address  Dept. Of Panchkarma, National Institute of Ayurveda,
Dept. Of Panchkarma, National Institute of Ayurveda,

RAJASTHAN
302002
India 
Phone    
Fax    
Email  gmangal108@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda jaipur 
 
Primary Sponsor  
Name  National Institute Of Ayurveda 
Address  madhav vilas palace, jorawarsingh gate, jaipur 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Ram prabodh Chaudhary Self  PG Scholar, National Institute of Ayurveda, 302002 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR RAM PRABODH CHAUDHARY  National Institute of Ayurveda   Dept. Of Panchkarma, National Institute of Ayurveda,
Jaipur
RAJASTHAN 		 9079823056

ramprabodhchaudhary7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients   Patients with Classical sign & symptoms of Gridhrasi and diagnosed cases of sciatica.  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A  Sahachara Taila Matra Basti in the day as 75ml for 16 days. 
Comparator Agent  Group B  Patra Pinda Swedana for 16 days 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with Classical sign & symptoms of Gridhrasi and diagnosed cases of sciatica.
2. Patient between ages of 16 to 70 years of either sex.
3. Patient ready to give consent.
 
 
ExclusionCriteria 
Details  1. Patients with severe renal and severe cardiac diseases.
2. Pregnant and lactating women
3. Malignancy and Tuberculosis of spine, after infectious condition of spine.
4. Patient who have lost the control on bladder and bowel.
5. Patients suffering from rheumatoid arthritis, gout and severe spinal trauma.
6. Patient with spinal implants.
7. Patient suffered from spina bifida
8. Patient suffered from severe systemic disorder
9. Sciatica due to fracture of spine
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in the symptoms of Sciatica  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
overall effect of the treatment in sciatica  1 year 6 month 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   03/09/2018 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 not published yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		  This clinical trial was conducted on 30 diagnosed patients of Sciatica (Gridhrasi).  Sciatica emerging as one of the most common diseases especially of the urban population. It is commonly seen in society as a prominent problem. The prevalence of this disease has been expected to be increasing due to improper lifestyle and poor working, sleeping and sitting postures.  Gridhrasi is a type of Vatavyadhi detailed described in Brihattrayi. It is observed that symptomatology of Gridhrasi very closely resembles with the disease Sciatica.   In Gridhrasi two types of Samprapati occurs, one is Vataja Gridhrasi in which vitiated Vata Dosha is the main causative factor. Another is Vata-Kaphaja Gridhrasi in which both Vata Dosha and Kapha Dosha are vitiated.  General Vata provocating factors are accepted as Nidana. Vyana Vayu and Slesaka Kapha are essential component to produce Gridhrasi.  Conclusion can be made from the present study that the symptomatic improvement in two groups, both groups show mild to moderate relief in management of Gridhrasi. On inter group comparison Group B (Patra panda swedana) was better than Group A (Sahachara Tail Matra Basti) on the parameters of Ruka, Stambha and Spandana.  Patra Pinda Swedana especially is more effective in Vatakaphaja Gridhrasi. It shows that effect of therapy was more in Group B in comparison to Group A.  No adverse effects were observed during the course of the study.  Therefore, it can be concluded that both groups show mild to moderate results while comparing in both groups, Patra Pinda Swedana is more effective than Sahachara Taila Matra Basti   in the management of Gridhrasi (Sciatica).   Acute & severe herniations and resulting myelopathy can be treated only with surgery and further maintained by use of Ayurvedic therapy.  
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