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CTRI Number  CTRI/2023/10/058293 [Registered on: 05/10/2023] Trial Registered Prospectively
Last Modified On: 29/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative Clinical Evaluation of Kati vasti and Matra Vasti in Gridhrasi Vata 
Scientific Title of Study   A COMPARATIVE CLINICAL EVALUATION OF KATI VASTI AND MATRA VASTI WITH VYOSADYA TAILA (VRNDA MADHAVA) IN THE MANAGEMENT OF GRDHRASI VATA 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mude Ashok Naik 
Designation  Post Graduate Scholar 
Affiliation  S.V. Ayurvedic College and Hospital 
Address  S.V. Ayurvedic College and Hospital SVIMS Campus, Tirupati,Andhra Pradesh.

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9182391020  
Fax    
Email  mudeashoknaik92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P Murali Krishna 
Designation  Principal and Professor 
Affiliation  S.V. Ayurvedic College 
Address  S.V. Ayurvedic College and Hospital SVIMS Campus, Tirupati,Andhra Pradesh.

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9848377916  
Fax    
Email  mkparasaram@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mude Ashok Naik 
Designation  Post Graduate scholar 
Affiliation  S.V. Ayurvedic College 
Address  S.V. Ayurvedic College and Hospital SVIMS Campus, Tirupati,Andhra Pradesh.

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9182391020  
Fax    
Email  mudeashoknaik92@gmail.com  
 
Source of Monetary or Material Support  
S.V. Ayurvedic College and Hospital SVIMS Campus, Tirupati,Andhra Pradesh 517507 
 
Primary Sponsor  
Name  S.V. Ayurvedic College and Hospital  
Address  SVIMS Campus, Tirupati,Andhra Pradesh 517507 
Type of Sponsor  Government 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 
Mude Ashok Naik  S.V.Ayurvedic Hospital  P.G. Department of Panchakarma, SVIMS Campus, Tirupati, Andhra Pradesh 517507
Chittoor
ANDHRA PRADESH 		 9182391020

mudeashoknaik92@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe   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-kaTibastiH, कटिबस्तिः (Procedure Reference: Vrnda Madhava 22/227-230, Procedure details: Kati Vasti with Vyosadya taila - 14 days)
(1) Medicine Name: Vyosadya taila, Reference: Vrnda Madhava 22/227-230, Route: Topical, Dosage Form: Taila, Dose: 300(ml), Frequency: od, Duration: 14 Days
2Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Vrnda Madhava 22/227-230, Procedure details: Matra Vasti with Vyosadya taila - 14 days)
(1) Medicine Name: Vyosadya taila, Reference: Vrnda Madhava 22/227-230, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Age Group of 18 to 70 years all genders
2.Low Backache radiating to lowerlimb
3.Patients presenting with lakshanas of Gridhrasi
4.Patients eligible for Kati Vasti
5.Patients eligible for Matra Vasti 
 
ExclusionCriteria 
Details  1.Patients with age below 18 years and above 70 years
2.Patients with DM & HTN, potts spine, malignancy of spine
3.patients underwent spinal surgeries, who are using medications for psychiatric disorders
4.patients associated with severe sytemic illness, space occupying leisons of the spinalcord 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the efficacy of kaṭi Vasti with Vyosadya taila in the management of Gṛdhrasī Vāta .
2. To evaluate the efficacy of Mātrā Vasti with Vyosadya taila in the management of Gṛdhrasī Vāta.
3. To compare the efficacy of kaṭi Vasti & Mātrā vasti with Vyosadya taila in the management
of Gá¹›dhrasÄ« vāta. 		 Before treatment (0thday) - Immediately after treatment – 15th day - One month after
treatment - 45th day. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To evaluate the efficacy of kaṭi Vasti with Vyosadya taila in the management of Gṛdhrasī Vāta .
2. To evaluate the efficacy of Mātrā Vasti with Vyosadya taila in the management of Gṛdhrasī Vāta.
3. To compare the efficacy of kaṭi Vasti & Mātrā vasti with Vyosadya taila in the management
of Gá¹›dhrasÄ« vāta. 		 One month after
treatment - 45th day. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   25/10/2023 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mudeashoknaik92@gmail.com].

  6. For how long will this data be available start date provided 04-01-2025 and end date provided 12-01-2099?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   The term Gá¹›dhrasÄ« indicates the typical gait that resembles of Gá¹›dhra (i.e.) “vulture”. Gá¹›dhrasÄ« Vāta is a Vataja nanatmaja vyadhi mentioned in almost all Ayurvedic classics. In which the patient will be having the symptoms like Stambha (stiffness), Ruk (pain), Todā(pricking sensation), over the Sphik (hip region), Kaá¹­i (waist), Pá¹›ista (back), UrÅ« (thigh), Jānu (knee), Jangha (calf region), in this order associated with Muhuá¹›spandata (frequent twitching sensation) are present. Gá¹›dhrasÄ«, according to its signs and symptoms can be correlated with Sciatica syndrome in contemporary western system of medicine. Sciatica is the condition in which there will be compression of sciatic nerve associated with pain, burning sensation, numbness, tingling sensation radiating from low back and upper buttock down the back of thigh, calf and foot. In changing present day life style, the incidence of sciatica is increasing gradually and affecting many people with a life time incidence varying from 14-40%. In Vātavyadhi aḍikarana of Vá¹›nda Mādhava, vyoṣādya taila has been indicated in Gá¹›dhrasÄ« vāta, which can be administered in the form of Mātrā Vasti and Kaá¹­i Vasti(Vá¹›nda Mādhava 22(227– 230)) 
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