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CTRI Number  CTRI/2023/10/058266 [Registered on: 04/10/2023] Trial Registered Prospectively
Last Modified On: 12/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study to evaluate the effect of vrishamuladi oil based enema and decoction based enema in the management of sciatica  
Scientific Title of Study   “A comparative clinical evaluation of the MaÌ…traÌ…vasti and YaÌ…pana vasti with VrÌ£sÌ£amuÌ„laÌ„di taila in the management of Gá¹›dhrasÄ«vāta”  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karanam Venkatesam Nalini 
Designation  Post Graduate Scholar 
Affiliation  Sri Venkateswara Ayurvedic college and Hospital,Tirupati 
Address  Room no.65,2nd floor, Department of Panchakarma,sri venkateswara Ayurvedic collage and Hospital,SVIMS Campus,Tirupati. Chittoor dt, Andhra Pradesh 517501 India

Chittoor
ANDHRA PRADESH
517501
India 
Phone  9000874502  
Fax    
Email  drnalinigiridhar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P Murali Krishna 
Designation  principal &professor 
Affiliation  Sri Venkateswara Ayurvedic college and Hospital,Tirupati 
Address  Room no.1, Ground floor,Sri Venkateswara Ayurvedic college and Hospital,SVIMS Campus,Tirupati. Chittoor dt, Andhra Pradesh

Chittoor
ANDHRA PRADESH
517501
India 
Phone  9848377916  
Fax    
Email  mkparasaram@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr P Murali Krishna 
Designation  principal &professor 
Affiliation  Sri Venkateswara Ayurvedic college and Hospital,Tirupati 
Address  Room no.1, Ground floor,Sri Venkateswara Ayurvedic college and Hospital,SVIMS Campus,Tirupati. Chittoor dt, Andhra Pradesh

Chittoor
ANDHRA PRADESH
517501
India 
Phone  9848377916  
Fax    
Email  mkparasaram@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateswara Ayurvedic college and Hospital, Tirupati 
 
Primary Sponsor  
Name  Sri Venkateswara Ayurvedic college and Hospital 
Address  SVIMS Campus,Tirupati,Andhra Pradesh ,517501 
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 
DrKVNalini  Sri Venkateswara Ayurvedic college and Hospital  PG Department of Panchakarma, SVIMS Campus, Tirupati.
Chittoor
ANDHRA PRADESH 		 9000874502

drnalinigiridhar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of TTDs S.V.Ayurvedic college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G570||Lesion of sciatic nerve. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-yApana-bastiH, यापन-बस्तिः (Procedure Reference: . Sri Pandita Kasinatha Sastri, Charaka Samhita, Vāta Vyādhi Adhikarana (170-171),Chaukambha Sanskrit sansthan , Varanasi,2012,pg.no.717, Procedure details: : Subjected to administer Yāpana vasti Vṛṣa mūladi taila once in a day for 16 days)
(1) Medicine Name: Vṛṣa mūladi taila., Reference: Sri Pandita Kasinatha Sastri, Charaka Samhita, Vāta Vyādhi Adhikarana (170-171),Chaukambha Sanskrit sansthan , Varanasi,2012,pg.no.717, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 16 Days
2Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: . Sri Pandita Kasinatha Sastri, Charaka Samhita, Vāta Vyādhi Adhikarana (170-171),Chaukambha Sanskrit sansthan , Varanasi,2012,pg.no.717, Procedure details: Subjected to administer Mātrāvasti with Vṛṣa mūladi taila once in a day for 16 days)
(1) Medicine Name: Vṛṣa mūladi taila, Reference: . Sri Pandita Kasinatha Sastri, Charaka Samhita, Vāta Vyādhi Adhikarana (170-171),Chaukambha Sanskrit sansthan , Varanasi,2012,pg.no.717, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 16 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  age between 18 to 60 years of all gender
low back ache radiating to lower limb
patients presenting with lakshanas of gridrasi vata
patients eligible for vasti
patients who are willing to participate 
 
ExclusionCriteria 
Details  Patients with age below 18 years and above 60 years
2. Patients with DM & HTN
3. Patients with potts’s spine.
4. Patients with Malignancy of spine.
5. Patients underwent spinal surgeries.
6. Patients associated with severe systemic illness.
7. Patients who are using medications for Psychiatric disorders.
8. Space occupying lesions of the spinal cord.
9. Those who are not willing to participate in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the efficacy of Mātrā vasti with Vṛṣamūlādi taila in the management of Gṛdhrasī Vāta .
2. To evaluate the efficacy of YāPana vasti with Vṛṣamūlādi taila in the management of Gṛdhrasī Vāta.
3. To compare the efficacy of Mātrāvasti & YāPana vasti with Vṛṣamūlādi taila in the management of Gṛdhrasī Vāta.
 		 • Before treatment (0th day)
• Immediately after treatment -17th day
• One month after treatment. - 47th day
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of YāPana vasti with Vṛṣamūlādi taila in the management of Gṛdhrasī Vāta.


 		 • Before treatment (0th day)
• Immediately after treatment -17th day
• One month after treatment. - 47th day
Group B:
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="42" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   05/10/2023 
Date of Study Completion (India) 01/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 [drnalinigiridhar@gmail.com].

  6. For how long will this data be available start date provided 18-06-2025 and end date provided 20-09-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   In Ä€yurveda, Vāta is considered as the primary factor that plays a major role in the genesis of many diseases. Vasti is one among the pañchakarma therapies, which is the method of administration of medicated decoctions, oil, ghee or milk through anal, vaginal or urethral route. Vasti is considered as the best treatment in Nānātmaja vāta rogas, it has been glorified as Aṛḍha chikitsā.  Among the Vasti, Mātrā Vasti is the one which has Snehadravya as an ingredient, administered to control Vāta and has brÌ£mÌ£hanÌ£a effect and it strengthens the Pāda, Jaṇgha, uÌ„ru, kaá¹­i and pá¹›isá¹­a. It can be given at any time or season and there are no rigid restrictions in terms of food and exercise.
YaÌ„pana type of vasti can be administered at all times. yaÌ„pana vasti performs dual function of both Anuvasana and Niruha, hence this vasti is Srotośodhaka and , so there is no need to administer separate Anuvasana while giving yaÌ„pana  Vasti.In Vāta vyaÌ„dhi chikitsādhyaÌ„ya in the verse (170-171) of Caraka Samhitha chikitsaÌ„sthaÌ„na VrÌ£sÌ£amuÌ„laÌ„di taila is said to be used in sarva Vāta vikaÌ„ra.And mentioned that It can be admistered for paÌ„na, abhyanga, nasya and anuvasana2 and emphasized that this is more useful in patients who are broken and shattered by disorders of vaÌ„ta...

  
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