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CTRI Number  CTRI/2021/08/035688 [Registered on: 16/08/2021] Trial Registered Prospectively
Last Modified On: 11/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of eranda tail virechana in sciatica 
Scientific Title of Study   Randomized controlled clinical trial to evaluate the efficacy of eranda sneha virechana in the management of gridhrasi with special reference to 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 Rohini Sunil Naikwad 
Designation  PG Scholar 
Affiliation  CSMSS ayurved college kanchanwadi aurangabad 
Address  CSMSS Ayurved College ground floor OPD no.- 15 Panchakarma department Paithan Road Kanchanwadi Aurangabad Aurangabad 431002 Maharashtra India

Aurangabad
MAHARASHTRA
431002
India 
Phone  9665933175  
Fax    
Email  rohininaikwad4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ganesh Barahate 
Designation  Associate professor 
Affiliation  CSMSS ayurved college kanchanwadi aurangabad 
Address  CSMSS Ayurved College ground floor OPD no.- 15 Panchakarma department Paithan Road Kanchanwadi Aurangabad Aurangabad 431002 Maharashtra India

Aurangabad
MAHARASHTRA
431002
India 
Phone  9404109895  
Fax    
Email  ayurganesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rohini Sunil Naikwad 
Designation  PG Scholar 
Affiliation  CSMSS ayurved college kanchanwadi aurangabad 
Address  CSMSS Ayurved College ground floor OPD no.- 15 Panchakarma department Paithan Road Kanchanwadi Aurangabad Aurangabad 431002 Maharashtra India

Aurangabad
MAHARASHTRA
431002
India 
Phone  9665933175  
Fax    
Email  rohininaikwad4@gmail.com  
 
Source of Monetary or Material Support  
CSMSS Ayurved College Paithan road Kanchanwadi Aurangabad 
 
Primary Sponsor  
Name  CSMSS ayurved college kanchanwadi aurangabad 
Address  CSMSS ayurved college paithan road kanchanwadi aurangabad 431002 Maharashtra 
Type of Sponsor  Private medical college 
 
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 Rohini Sunil Naikwad  CSMSS ayurved hospital and research center   CSMSS ayurved hospital and research center ground floor OPD no. 15 panchakarma department paithan road kanchanwadi aurangabad Maharashtra 431002
Aurangabad
MAHARASHTRA 		 9665933175

rohininaikwad4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: gridhrasi,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: charak chikitsa adhyaya 28 shloka 83, Procedure details: 1 Deepan pachan with Panchakola churna 5 gms for 3 to 7 days. 2 Oral intake of Til taila (snehapana) for 3 to 7 days. 3 Snehana & swedana for 3 days. 4 Virechana (purgation) induced with Trivrutta churna gutika 20 gms))
(1) Medicine Name: Trivrutta churna gutika, Reference: chkradatta adhyaya 71 shloka 8 & 9, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 20(g), Frequency: od, Duration: 1 Days
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: charak samhita chapter 28 shloka 83 , Procedure details: 1 Deepan & Pachan with panchkola churna (5 gm) for 3 to 7 days 2 Oral intake of Til taila (snehapana) for 3 to 7 days. 3 Snehana & swedana for 3 days. 4 Virechana (purgation) induced with Eranda taila orally (20 to 50 ml))
(1) Medicine Name: Eranda Taila, Reference: Bhavprakash madhyam khanda vatavyadhi adhyaya shloka 137, Route: Oral, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient with signs and symptoms of gridhrasi having duration of illness up to 2 years
Age group between 20-60 years irrespective of gender, occupation or economic status
Patient with positive straight leg raising test i.e. between 30-70 degree
Patient fit for virechana therapy 
 
ExclusionCriteria 
Details  Patient below age of 20 years and above 60 years
Ayogya for virechana
Neoplastic, traumatic and infective conditions of spine
Patient with other severe systemic disorders like DM, cardiac diseases 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the effect of eranda sneha virechana in gridhrasi  10-18 days with follow up first after snehapana and second after samsarjana krama 
 
Secondary Outcome  
Outcome  TimePoints 
To study gridhrasi as per ayurvedic texts
To study sciatica according to modern texts
To study the virechana karma in detail
To compare eranda sneha virechana with trivrutta churna gutika in management of gridhrasi  		 10-18 days with follow up first after snehapana and second after samsarjana krama 
 
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)   20/08/2021 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The changing lifestyle is causing a deteriorating effect on the physical, psychological and emotional health of people. Changed lifestyle, bad postures, excessive travelling with jerky movements produces stress on the spinal cord. It negatively impacts the quality of life of patients and disturbs daily routine. The most common disorder which affects the movements of leg particularly in most predominant period of life is sciatica. The common corresponding annual incidences of an episode of sciatica ranges from 1-6 %. Acharya Vangasena describes virechana for gridhrasi. Acharya Bhavaprakasha has mentioned eranda as param aushadha in gridhrasi. Hence this study is planned to evaluate the efficacy of eranda sneha virechana in management of gridhrasi with special reference to sciatica. 
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