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CTRI Number  CTRI/2025/06/089812 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 27/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Ayurvedic Management in Sciatica 
Scientific Title of Study   Comparative Clinical Evaluation Of Matra Basti And Kati Basti With Mulaka Tailam In The Management Of Grdhrasi Vata Open Parentheses Sciatica Close Parentheses 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nookala Hemasree 
Designation  Post Graduate Scholar 
Affiliation  S.V. Ayurvedic College and Hospital  
Address  Room no.65, second floor, Department of Panchakarma, S.V. Ayurvedic College and Hospital, Tirupati Chittoor

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9550948325  
Fax    
Email  nookalahemasree@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr D Venkata Ravi Krishna 
Designation  Assistant Professor  
Affiliation  S.V. Ayurvedic College and Hospital  
Address  PG Department of Panchakarma, S.V. Ayurvedic College and Hospital, Tirupati Chittoor

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9490768785  
Fax    
Email  ravi.deevi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr D Venkata Ravi Krishna 
Designation  Assistant Professor  
Affiliation  S.V. Ayurvedic College and Hospital  
Address  PG Department of Panchakarma, S.V. Ayurvedic College and Hospital, Tirupati Chittoor


ANDHRA PRADESH
517507
India 
Phone  9490768785  
Fax    
Email  ravi.deevi@gmail.com  
 
Source of Monetary or Material Support  
S.V. Ayurvedic College and Hospital, Tirupati, Andhra Pradesh, 517507 
 
Primary Sponsor  
Name  S.V. Ayurvedic College and Hospital  
Address  S.V. Ayurvedic College and Hospital, 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 
Dr Nookala Hemasree  S.V. Ayurvedic Hospital   Room no. 65, second floor, PG Department of Panchakarma, S.V. Ayurvedic College and Hospital, Tirupati Chittoor 517507 Andhra Pradesh
Chittoor
ANDHRA PRADESH 		 09550948325

nookalahemasree@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 and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Matra Basti (Procedure Reference: Caraka Samhita Siddhi Sthana 4 Chapter 24 Sloka, Procedure details: Matra Basti for 14 days)
(1) Medicine Name: Mulaka Tailam, Reference: Bhela Samhita Cikitsa Sthana 24 Chapter 44 1/2-45 Sloka, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 14 Days
2Comparator ArmProcedure-Kati Basti (Procedure Reference: Astanga Hrudaya Sutra Sthana 22 Chapter 23-24 Sloka, Procedure details: Kati Basti for 14 days)
(1) Medicine Name: Mulaka Tailam, Reference: Bhela Samhita Cikitsa Sthana 24 chapter 44 1/2-45 Sloka, Route: Topical, Dosage Form: Taila, Dose: 300(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients presenting with symptoms and signs of Grdhrasi
Patients presenting with symptoms and signs of Sciatica
Patients eligible either for Matra Basti or Kati Basti 
 
ExclusionCriteria 
Details  Patients with Uncontrolled Diabetes Mellitus and Hypertension
Spinal Trauma, Neoplasms, Malignancies, TB, Inflammatory conditions
Patients who underwent Spinal surgeries
Patients with severe systemic illnesses like CHF, CKD, HIV, HBV 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the efficacies of Matra Basti and Kati Basti with Mulaka Tailam on Grdhrasi Vata(Sciatica)  At baseline, after completion of treatment 15th day , 45th day 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacies of Matra Basti & Kati Basti with Mulaka Tailam on Grdhrasi Vata(Sciatica)  At baseline, 15th day 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/07/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  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 - Any purpose.

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

  6. For how long will this data be available start date provided 25-12-2026 and end date provided 31-12-2100?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Grdhrasi which is one among the eighty nanatmaja vata vyadhis. It is caused by vata subsequently there is a kaphanubandha. Grdhrasi, the name itself indicates the gait shown by the patient which mimics the gait of the Grdhra or Vulture.

The cordinal signs and symptoms of Grdhrasi are Stambha(stiffness), Ruk (pain), Toda (pricking sensation), and Muhuspandana (frequent twitching) in the Sphik (hip), Kati (low back), Prusta(back), Uru (thigh), Janu (back of knee), Jangha (calf region) and Pada (foot) in order. In Grdhrasi, Tandra (drowsiness), Gaurava (heaviness), Aruci (anorexia) may be present if kapha is associated with vata. Susruta explained Sakthnot ksepam nigrhniyat.

The clinical features seen in Grdhrasi Vata can be correlated with Sciatica of modern medicine. Sciatica is very painful condition in which there will be compression of sciatic nerve associated with pain begins in lumbar region and radiate along the posterolateral aspect of thigh and leg. Hence movement of affected lower limb is restricted and patient is not able to walk properly.

In changing present day life style, the incidence of sciatica is increasing gradually and affecting many people with a life time incidence is reported to be in between 10% to 40% with an annual incidence of 1% to 5%. 

Contemporary medicine has varied therapeutic options such as medication with analgesics, NSAIDS and even surgical corrections in advanced conditions. But, the recurrences are common in this kind of management. Ayurveda pancakarma therapies will be coming into picture to seal them effectively.

In Vatavyadhi Cikitsa Adhyaya of Bhela Samhita, Mulaka Tailam has been indicated in Grdhrasi Vata, which can be administered in the form of Matra Basti and Kati Basti.



 
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