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CTRI Number  CTRI/2022/11/046958 [Registered on: 01/11/2022] Trial Registered Prospectively
Last Modified On: 28/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To Evaluate the Clinical Efficacy of Vishwadi Guggulu and Gridhrasihar Tail Kati Basti in The Management of Gridhrasi (Sciatica) 
Scientific Title of Study   A Clinical Study on Vishwadi Guggulu and Gridhrasihar Tail Kati Basti in The Management of Gridhrasi (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 MAHAVEER BAIRWA 
Designation  P G SCHOLAR 
Affiliation  University Post Graduate Institute of Ayurved Studies and Research Jodhpur 
Address  Room No 121 P G Department of Kayachikitsa University Post Graduate Institute of Ayurved Studies And Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
OPD No 4 P G Department of Kayachikitsa University Post Graduate Institute of Ayurved Studies And Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India 
Phone  7742897666  
Fax    
Email  mahaveerbairwa.ms@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr BRAHMANAND SHARMA 
Designation  ASSISTANT PROFESSOR 
Affiliation  University Post Graduate Institute of Ayurved Studies and Research Jodhpur 
Address  Room No 118 P G Department of Kayachikitsa University Post Graduate Institute of Ayurved Studies And Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
OPD No 4 P G Department of Kayachikitsa University Post Graduate Institute of Ayurved Studies And Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India 
Phone  9460318138  
Fax    
Email  bkmudgal9@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr MAHAVEER BAIRWA 
Designation  P G SCHOLAR 
Affiliation  University Post Graduate Institute of Ayurved Studies and Research Jodhpur 
Address  Room No 121 P G Department of Kayachikitsa University Post Graduate Institute of Ayurved Studies And Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
OPD No 4 P G Department of Kayachikitsa University Post Graduate Institute of Ayurved Studies And Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India 
Phone  7742897666  
Fax    
Email  mahaveerbairwa.ms@gmail.com  
 
Source of Monetary or Material Support  
University Post Graduate Institute of Ayurved Studies and Research Jodhpur  
 
Primary Sponsor  
Name  University Post Graduate Institute of Ayurveda Studies and Research Jodhpur Rajasthan 
Address  University Post Graduate Institute of Ayurveda Studies And Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan 342037  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Dr Mahaveer Bairwa  P G Department of Kayachikitsa University Post Graduate Institute of Ayurved Studies and Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan 342037 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahaveer Bairwa  University Post Graduate Institute of Ayurved Studies and Research Jodhpur Rajasthan  P G Department of Kayachikitsa Opd No 4 University Post Graduate Institute of Ayurved Studies and Research Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan 342037
Jodhpur
RAJASTHAN 		 7742897666

mahaveerbairwa.ms@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Of Ethics Committee University Post Graduate Institute of Ayurved Studies and Research Jodhpur Rajasthan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G544||Lumbosacral root disorders, not elsewhere classified. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kaTibastiH, कटिबस्तिः (Procedure Reference: Vridha nighantu ratnakar, Procedure details: kati basti on back region )
(1) Medicine Name: Gridhrasihar tail, Reference: Vridha nighantu ratnakar, Route: Topical, Dosage Form: Taila, Dose: 300(ml), Frequency: od, Duration: 15 Days
(2) Medicine Name: Vishwadi Guggulu, Reference: Vridha Nighantu Ratnakar, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 45 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Patients with chronicity of less than 10 years.
2 Patients willing to signature the consent form for the clinical trial.

3 The patients between age group of 20-70 years in either sex presenting with clinical features of sciatica.
4 Well diagnosed & confirmed cases of Gridhrasi (Sciatica) on the basis of subjective and objective parameters.
5 S.L.R. Test positive in affected legs as objective measures for diagnosis.
 
 
ExclusionCriteria 
Details  1 Tuberculosis of Vertebral Column
2 Carcinoma of Spine
3 Severe Traumatic Injury
4 Cardiovascular Disease
5 Uncontrolled Diabetes Mellitus
6 Pregnant women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in subjective and objective parameters before treatment and after treatment.  45 Days 
 
Secondary Outcome  
Outcome  TimePoints 
To Evaluate Efficacy of Vishwadi Guggulu and Gridhrasihar Tail Kati Basti in The Management of Gridhrasi (Sciatica)  45 Days 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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 
Date of First Enrollment (India)   07/11/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Gridhrasi is one of the Nanatamj Vata Vyadhi described by Acharya Charaka which can be correlate with sciatica. Sciatica most commonly occurs when a herniated disc, bone spure on the spine or narrowing of the spine (spinal stenosis) compresses part of the nerve this causes inflammation, pain and numbness in the affected leg. Most surgeries involve tissues around a nerve and nerve injury is a possibility. Sciatica is more common in adults between 30 to 60 years of age. Modern science’s surgery is more complicated except giving temporary relief through analgesics & muscle relaxants.

            Ayurveda medicines in Gridhrasi are safe and without any side effects, Therefore Ayurveda science may provide a satisfactory treatment of the root cause of this disease.

There are two types of Gridhrasi.

   1.Vataja Gridhrasi

   2.VataKaphaja Gridhrasi

This medicine suppresses Vata Kapha so it will work in this disease.

         That’s why this study is being launched as a clinical study by Vishwadi Guggulu and Gridharsihar Tail Kati Basti in the management of Gridhrasi (Sciatica).

 
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