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CTRI Number  CTRI/2025/03/083571 [Registered on: 27/03/2025] Trial Registered Prospectively
Last Modified On: 26/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Assessment of the effect of Ayurveda treatment in sciatica  
Scientific Title of Study   ASSESSMENT OF HEALTH-RELATED QUALITY OF LIFE WITH SELECTED AYURVEDIC TREATMENT MODALITIES IN SCIATICA : AN OBSERVATIONAL STUDY  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHEREENA K M 
Designation  P G SCHOLAR 
Affiliation  VAIDYARATNAM AYURVEDA COLLEGE THAIKKATTUSSERY 
Address  P G Scholar Department of Kayachikitsa Vaidyaratnam Ayurveda College Thaikkattussery Ollur

Thrissur
KERALA
680306
India 
Phone  9446936826  
Fax    
Email  drshereenakm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR DILEEP K S 
Designation  ASSOCIATE PROFESSOR 
Affiliation  VAIDYARATNAM AYURVEDA COLL 
Address  Associate Professor Vaidyaratnam Ayurveda College Thaikkattussery Ollur

Thrissur
KERALA
680306
India 
Phone  9961045901  
Fax    
Email  dileepkshankar@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR DILEEP K S 
Designation  ASSOCIATE PROFESSOR 
Affiliation  VAIDYARATNAM AYURVEDA COLL 
Address  Associate Professor Department of Kayachikitsa Thaikkattussery Ollur

Thrissur
KERALA
680306
India 
Phone  9961045901  
Fax    
Email  dileepkshankar@gmail.com  
 
Source of Monetary or Material Support  
Vaidyaratnam Ayurveda College Hospital,Thaikkattussery, Ollur 
 
Primary Sponsor  
Name  SHEREENA K M 
Address  P G Scholar Department of Kayachikitsa Vaidyaratnam Ayurveda College Thaikkattussery Ollur 
Type of Sponsor  Other [Self] 
 
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 
DR DILEEP K S  VAIDYARATNAM AYURVEDA COLLEGE HOSPITAL KAYACHIKITSA IP DEPARTMENT  THAIKKATTUSSERY OLLUR PIN 680306
Thrissur
KERALA 		 09961045901

dileepkshankar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE FOR RESEARCH VAIDYARATNAM AYURVEDA COLLEGE OLLUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M519||Unspecified thoracic, thoracolumbar and lumbosacral intervertebral disc disorder. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Participants fulfilling ATLAS model with a threshold score of 5 or above12
2 Participants with a positive SLR test
3 Participants of age group 20 to 60 years irrespective of gender 13
4 Patients who are admitted in Vaidyaratnam Ayurveda College Hospital Ollur Kayachikitsa Inpatient department diagnosed as sciatica for a minimum period of 15 days
 
 
ExclusionCriteria 
Details  1 Patient with recent history of major trauma or fracture
2 Patient with other known metabolic systemic comorbidities and serious mental illness
3 Diagnosed case of congenital spinal abnormalities chronic joint disorders bone cancer spinal TB and paraplegia
4 Chronic IVDP cases treated with surgery
5 Pregnant women and lactating women
6 Participants having completed any other clinical trial within 6 months
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Oswestry Disability questionnaire
2. Range of movement by goniometer (Hip flexion with extended knee)
 		 day 0
day 15
day 30
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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   N/A 
Date of First Enrollment (India)   28/04/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Sciatica is a musculoskeletal condition of mild or severe radiating pain to buttocks, thigh, calf and foot from lumbar region. Sciatica is due to impingement on the root or over the course of sciatic nerve. In Ayurveda gridhrasi can be correlated to sciatica. Gridhrasi is explained under vatavyadhi in all samhithas. General vatavyadhi chikitsa as well as specific treatments are explained in gridhrasi. This is an observational study of Ayurvedic treatment modalities in sciatica (gridhrasi) involving internal and external administration. Internally sahacharadi kashaya and shuntibaladi choorna as anupana is given throughout the treatment. Nirgundi eranda is given along with it for anulomana. External treatment including swedana, upanaha, snehasweda, yogavasthi and kateevasthi are planned as per the treatment modality. The assessment of Health-Related Quality of Life with these Ayurvedic treatment modalities is planned to be analyzed  in this observational study with assessment tools and questionnaire.

 
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