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CTRI Number  CTRI/2026/03/106209 [Registered on: 13/03/2026] Trial Registered Prospectively
Last Modified On: 13/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The research compares two different dosing methods that is fixed dose and ascending dose of an ayurvedic oil enema that is matra basti using mulakadi taila to treat gridhrasi that is sciatica  
Scientific Title of Study   A randomized double arm comparative clinical study to evaluate the efficacy of matra basti by fixed dose and ascending dose patterns with mulakadi taila in the management of gridhrasi vis a vis sciatica 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Niveditha c n 
Designation  Pg scholar 
Affiliation  Ayurveda mahavidayalaya and hospital 
Address  Ayurveda mahavidyalaya and hospital heggeri extension old hubli hubballi karnataka india 580024
Opd no 2 department of panchakarma ayurveda mahavidyalaya and hospital heggeri extension old hubli hubballi
Dharwad
KARNATAKA
580024
India 
Phone  9902784496  
Fax    
Email  nivedithanagraj1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Harish kulkarni 
Designation  professor hod 
Affiliation  Ayurveda mahavidayalaya and hospital 
Address  Ayurveda mahavidyalaya and hospital heggeri extension old hubli hubballi
Opd 2 department of panchakarma ayurveda mahavidyalaya and hospital heggeri extension old hubli hubballi
Dharwad
KARNATAKA
580024
India 
Phone  9902784496  
Fax    
Email  harishpk2007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Niveditha c n 
Designation  Pg scholar 
Affiliation  Ayurveda mahavidayalaya and hospital 
Address  Ayurveda mahavidyalaya and hospital heggeri extension old hubli hubballi
Ayurveda mahavidyalaya and hospital heggeri extension old hubli hubballi

KARNATAKA
580024
India 
Phone  9902784496  
Fax    
Email  nivedithanagraj1@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Niveditha c n 
Address  Ayurveda mahavidyalaya and hospital heggeri extension old hubli hubballi 580024 
Type of Sponsor  Private 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 Niveditha c n  Auyrveda mahavidyala and hospital  Ayurveda mahavidyalaya and hospital heggeri extension old hubli hubballi Ayurveda mahavidyalaya and hospital heggeri extension old hubli hubballi
Dharwad
KARNATAKA 
9902784496

nivedithanagraj1@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:M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-Matra basti (Procedure Reference: charaka samhitha siddhi sthana 4th chapter 53rd shloka, Procedure details: Subject is made to lie in left lateral position by keeping left leg straight & right leg flexed at knee joint Mulakadi taila in a increasing dose of 24ml 30ml 36ml 42ml 48ml 54ml 60ml 66ml & 72ml for 9 days will be administer using red rubber catheter no 11)
2Intervention ArmProcedure-Matra basti (Procedure Reference: charaka samhitha siddhi sthana 4 th chapter 53rd shloka, Procedure details: Subject is made to lie in left lateral position by keeping left leg straight & right leg flexed at knee joint Mulakadi taila in a dose 72 ml for 9 days will be administer using red rubber catheter no 11)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Subjects with symptoms of radiating pain from sphik that is buttock and kati that is lumbar region to prishta that is back uru that is thigh janu that is knee jangha that is calf region and pada that is feet
Subjects between age group 20-80 years of irrespective of gender
Subjects of both vataja and vata kaphaja gridhrasi will be considered for the study
Subjects who are fit for basti karma will be included after proper evaluation
Chronicity of less than 5 years without any deformity and complications
 
 
ExclusionCriteria 
Details  Subjects who are unfit for basti karma
Subjects not willing to give informed consent
Subjects with evidence of congenital anomalies of the spine tuberculosis of spine traumatic fracture neoplasms epidural abscess and others will be excluded after proper examination
Any other systemic diseases which interfere with the course of treatment pregnancy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in symptoms that is ruk toda sthamba spandana numerical pain rating scale
 
baseline 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in severity o f gridhrasi assessed by straight leg raised test
Improvement in range of movements of lumbar spine 
baseline 8 weeks 
 
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   Phase 1 
Date of First Enrollment (India)   26/03/2026 
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="0"
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  
 Panchakarma forms the basis of purificatory therapy in ayurveda  it plays a crucial role in restoring the bio purificatory functions of the body  movements signifies vitality but in conditions like  gridhrasi this is impaired making daily activities difficult gridhrasi comes under nanamataja vata vyadhi the cardinal signs and symptoms of gridhrasi are sthamba ruk toda  muhuspandana in the sphik kati uru janu jangha and pada  in order along with sakthikshepanigraha that is restriction in upward lifting of lower limb in gridhrasi tandra gaurava and aruchi may be present if kapha is associated with vata sciatica resembles the disease gridharsi in ayurveda It causes excruciating pain which radiates through the pathway of sciatic nerve here piercing type of pain is present which restricts the movement of affected leg the gait resembles the bird vulture
About 80 to 90 percent of people get affected by low back pain in general an estimated 5 to 10 percent of patients with low back pain have sciatica whereas the lifetime prevalence of low back pain ranges from 49 to 70 percent the annual prevalence of disc related sciatica in the general population is estimated at 2point 2 percent the management provided by the contemporary medicine for this condition is either conservative or surgical in nature and have certain limitation including dependency and side effects such as dizziness stomach upset  rashes or serious skin reaction nephrotoxicity and diarrhoea  such limitations in contemporary science provide evident scope for research work in ayurveda in this condition
In ayurveda  basti is one among panchakarma procedure and it is the best treatment for vata vyadhi as quoted by maharshi charaka that basti vataharanam shrestam acharya charaka consider basti as ardhachikitsa It is claimed as the main radical aspect of chikitsa seeking the absolute cure of disease by eliminating its root cause
 Matra basti is the hriswa matra of sneha basti  it can be given at any time and does not cause any complication even though the person follows his or her desired ahara and vihara
Mulakadi taila is a formulation mentioned in gadanigraha is indicated in the management of gridhrasi  it is vatashamaka
 Acharya gayadasa while commenting on sushruta samhitha has mentioned one and half pala as dose of matra basti of 72ml  this is considered as fixed dose in clinical practice           
 Acharya adamalla while commenting on sarangadhara samhitha has described an ascending dose pattern of sneha matra in the form of matra basti his may help in better retention and absorption of basti and thus may produce a better effect hence a comparative study will be under taken to evaluate the efficacy of fixed dose and ascending dose patterns of matra basti with mulakadi taila in the management of gridhrasi to ascertain the effect of either of the treatment modalities
 No previous research work was done on above mentioned modalities so here an effort will be made to compare the efficacy of matra basti in fixed dose and ascending dose in gridhrasi with mulakadi taila
 
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