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CTRI Number  CTRI/2024/01/061202 [Registered on: 08/01/2024] Trial Registered Prospectively
Last Modified On: 04/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical study to evaluate efficacy of sahachar oil matra basti in management of gridhrasi (sciatica ) 
Scientific Title of Study   Clinical study to evaluate efficacy of sahachar tail matra basti in management of gridhrasi 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Iravati Laxman Kulkarni 
Designation  MD Scholar Panchakarma 
Affiliation  Tilak ayurved mahavidyalaya,pune 
Address  Tilak ayurved mahavidyalaya,Department of panchakarma OPD no 12 Rasta peth

Pune
MAHARASHTRA
411011
India 
Phone  7588307923  
Fax    
Email  iravatikulkarni18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Rajendra S Huparikar 
Designation  Head of Department 
Affiliation  Tilak ayurved mahavidyalaya,pune 
Address  Tilak ayurved mahavidyalaya,Department of panchakarma OPD no 12 Rasta peth

Pune
MAHARASHTRA
411011
India 
Phone  9823050402  
Fax    
Email  ayurvedapune@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vd Rajendra S Huparikar 
Designation  Head of Department 
Affiliation  Tilak ayurved mahavidyalaya,pune 
Address  Tilak ayurved mahavidyalaya,Department of panchakarma OPD no 12 Rasta peth

Pune
MAHARASHTRA
411011
India 
Phone  9823050402  
Fax    
Email  ayurvedapune@gmail.com  
 
Source of Monetary or Material Support  
Tilak ayurved mahavidyala & seth tarachand ramnath charitable ayurved hospital, rasta peth pune - 411011 
 
Primary Sponsor  
Name  Tilak ayurved mahavidyalaya pune 
Address  Rasta peth pune 411011 
Type of Sponsor  Research institution and hospital 
 
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 
Vd Iravati Laxman Kulkarni  Tilak ayurved mahavidyalaya and Seth tarachand ramnath dharmartha hospital  OPD NO. 12, FIRST FLOOR, RASTA PETH
Pune
MAHARASHTRA 		 7588307923

iravatikulkarni18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Gadanigraha part 2 shlok 102-108, Procedure details: Matra basti(60ml)of sahachar tail will be administered through anal route after meal once in a day for 7 days )
(1) Medicine Name: Sahachar tail, Reference: Gadanigraha part 2 shlok 102-108, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient with age group 30 to 60 years
2.Patient having minimum 3 signs and symptoms of gridhrasi i.e shool, sthambha, toda, graha, gridhravatachalan, kaphaj lakshanas- tandra, gaurava, vanhimardava,bhaktadwesh. 
 
ExclusionCriteria 
Details  1.Patients who are contraindicated for basti as per brihatrayi.
2.Mentruating womens, medical conditions related to female reproductive system, pregnant and PNC patients.
3.Patients having spinal deformities, severe traumatic injury to spinal cord and having unbearable pain
4.Patients having chronic and major illness like cardiac, renal, autoimmune diseases etc.
5.known sero positive
6. known potts spine, acute vertebral disc prolapse, bamboo spine, vertebral fusion
7. any abdominal surgical procedures  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of sahachar tail matra basti in management of gridhrasi   7 days 
 
Secondary Outcome  
Outcome  TimePoints 
shoola, stambha, toda, spandan, graha, tandra, aruchi, gaurav,
slr test, slump test, oxford pain chart, walking time. 		 14 days 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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 2/ Phase 3 
Date of First Enrollment (India)   15/01/2024 
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="6"
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   Number of patients suffering with  gridhrasi  is becoming quite high. The modern science is mainly based on symptomatic treatment which includes analgesics and physiotherapy. Surgery is another option but is economically not possible to every patient. 
In ayurvedic samhitas there are many better options available for treatment of gridhrasi. Gridhrasi is one of the vaatvyadhi and basti being ardha chikitsa of vaatvyadhi, it will also be effective in gridhrasi. Hence a clinical study to evaluate efficacy of sahachar tail matra basti in management of gridhrasi and the observations will be drawn from the outcome of patients.
 
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