| 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 |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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
|
|
|
Primary Sponsor
|
| Name |
Dr Niveditha c n |
| Address |
Ayurveda mahavidyalaya and hospital heggeri extension old hubli hubballi 580024 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | 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)
| | 2 | Intervention Arm | Procedure | - | 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)
|
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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.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Open Label |
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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 |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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 |