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CTRI Number  CTRI/2018/04/013048 [Registered on: 04/04/2018] Trial Registered Retrospectively
Last Modified On: 04/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective study 
Study Design  Other 
Public Title of Study   A study to find out the differences in the treatments of low back pain with radiating pain to leg among 3 doctors in Amrita school of Ayurveda 
Scientific Title of Study   An observational prospective study to find out the converging and diverging factors in the treatment protocol of sciatica among the physicians of Panchakarma department at Amrita school of Ayurveda 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajisha DH 
Designation  PG Scholor 
Affiliation  Amrita school of Ayurveda 
Address  PG Scholor Department of Panchakarma Amrita school of Ayurveda Clappana PO Vallikavu, Kollam
Raj bhavan Venkavila Vattavila PO 695132
Thiruvananthapuram
KERALA
690525
India 
Phone  9495521660  
Fax    
Email  drajisha13jan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anandaraman P V  
Designation  Associate professor 
Affiliation  Amrita school of Ayurveda 
Address  Associate professor Department of Panchakarma Amrita school of Ayurveda Clappana PO Vallikavu, Kollam

Kollam
KERALA
690525
India 
Phone  9495130595  
Fax    
Email  dr.ananthramsharma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anandaraman P V  
Designation  Associate professor 
Affiliation  Amrita school of Ayurveda 
Address  Associate professor Department of Panchakarma Amrita school of Ayurveda Clappana PO Vallikavu, Kollam


KERALA
690525
India 
Phone  9495130595  
Fax    
Email  dr.ananthramsharma@gmail.com  
 
Source of Monetary or Material Support  
Amrita School of Ayurveda clappana p o vallikavu, kollam 
 
Primary Sponsor  
Name  Dr Ajisha DH 
Address  PG Scholor Amrita school of Ayurveda Clappana PO Vallikavu, Kollam 690525 
Type of Sponsor  Other [] 
 
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 
Ajisha D H  Amrita school of ayurveda  Amrita school of ayurveda, clappana p o , vallikavu, kollam
Kollam
KERALA 
9495521660

drajisha13jan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Amrita institute of medical sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  sciatica ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  • Patients who are diagnosed by the physicians as Gridhrasi and assessed by a Physiotherapist being ≥70% confident of a diagnosis of sciatica.
• Patients with signs and symptoms of Sciatica mentioned in ICD 10
 
 
ExclusionCriteria 
Details  1)Patients who are diagnosed by Physician as Gridhrasi and the Physiotherapist is not confident enough to diagnose as Sciatica
2)Known case of neoplasm, bone TB, fracture of spine, malignancy, uncontrolled diabetes and uncontrolled hypertension
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
convergence and divergence in the treatment protocol of sciatica  After each set of treatments and follow up 
 
Secondary Outcome  
Outcome  TimePoints 
divergence in the treatment protocol of sciatica  6 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1 
Date of First Enrollment (India)   09/03/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/03/2018 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="10" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

 Sciatica is a condition where there is distribution of pain along the course of sciatic nerve, i.e, which the pain radiates from the low back to buttock and legs. Sciatica of contemporary medical science is closely equivalent to Gridhrasi by its similarity in the course of pain.

On considering sciatica as an independent disease it is a relatively common condition with lifetime incidences varying from 1.6%-43%. The chance of Sciatica is expected to increase in the upcoming years due to sedentary life style, the increased use of computerization and also due to increasing body weight, mental stress, hectic work schedules and transportation methods.

Ayurveda treatment claims high success rate in Sciatica. Even though the symptoms exhibited by the patients are same, treatment protocol changes from physicians to physician may be based on logic in assessing dosha and dushya.

So the aim of the study is  to find out the converging and diverging factors in the treatment protocol of Sciatica among the physicians.

20 patients each of 3 physicians in Panchakarma IPD of Amrita school of ayurveda, suffering from  sciatica will be selected and the treatment and condition will be observed. Later convergence and divergence will be recorded. After analyzing all these the overall convergence and divergence can be listed out with the logic behind it.

 
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