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CTRI Number  CTRI/2019/07/020038 [Registered on: 04/07/2019] Trial Registered Prospectively
Last Modified On: 29/06/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of ayurveda in Sciatica 
Scientific Title of Study   To Evaluate And Compare The Effectiveness Of Integrated Approach Panchakarma And Physiotherapy In Sciatica.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradeep Grampurohit 
Designation  Reader Department of Panchakarma 
Affiliation  KAHERs Shri B M K Ayurveda Mahavidyalaya 
Address  Panchakarma OPD No 04 and IPD KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9964144197  
Fax    
Email  Pradeepgrampurohit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep Grampurohit 
Designation  Reader Department of Panchakarma 
Affiliation  KAHERs Shri B M K Ayurveda Mahavidyalaya 
Address  Panchakarma OPD No 04 and IPD KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9964144197  
Fax    
Email  Pradeepgrampurohit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep Grampurohit 
Designation  Reader Department of Panchakarma 
Affiliation  KAHERs Shri B M K Ayurveda Mahavidyalaya 
Address  Panchakarma OPD No 04 and IPD KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9964144197  
Fax    
Email  Pradeepgrampurohit@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi 590003 
 
Primary Sponsor  
Name  Dr Pradeep Gramapurohit 
Address  KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi 590003 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradeep Grampurohit   KLE Ayurveda Hospital   OPD No 04 and IPD department of Panchakarma of KLE Ayurveda Hospital Shahapur Belagavi 590003
Belgaum
KARNATAKA 		 9964144197

Pradeepgrampurohit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagaum 590003  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M818||Other osteoporosis without currentpathological fracture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Integrated approach   Erandamula Niruha Basti 500ml throught rectal route for 3days, Anuvasana Basti with Dhanvantari 60ml through rectal route for 4 days, Kati basti with Sahacharadi Taila 300ml external treatment,TENS for 15 minutes for 7 days, TRACTIONS for 15 minutes for 7 day, EXERCISE for 15 for 7 days 
Comparator Agent  Panchakarma Treatment  Sadyovirechana, Erandamula Niruha Basti 500ml throught rectal route for 3days, Anuvasana Basti with Dhanvantari 60ml through rectal route for 4 days, Kati basti with Sahacharadi Taila 300ml external treatment, 
Comparator Agent  Physiotheraphy  TENS for 15 minutes for 7 days, TRACTIONS for 15 minutes for 7 day, EXERCISE for 15 for 7 days, HOT Moist Pack15 for 7 days. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with signs and symptoms of Gridhrasi were selected irrespective of their religion, sex, occupation, and socio economic status,
Age group 20-60yrs,
SLR test angle 30-70 degree
All subjects with unilateral or bilateral radiation of pain in the sciatica nerve distribution.
 
 
ExclusionCriteria 
Details  History of spinal surgery and vertebral fracture.
Evidence of IHD, tuberculosis.
Clinical condition such as hyper sensitive skin, cardiac pace maker, pregnancy and lactating women.
Established tumors/malignancy.
Motor weakness such as stroke, diabetic neuropathy.
Patients having back pain due to non-spinal illness will excluded e.g. UTI, gastrointestinal diseases, and uterine diseases.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Integrated protocol will be effective in treating
Sciatica. 		 1st 8th, 15th Day 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   01/01/2020 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Study is being conducted with the objective of evaluating the combined effect of treatment (Panchakarma and Physiotherapy) it was observed that individual treatments have good results in patients so this study is being taken up to observe if combined therapy would give better results.

 
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