FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072766 [Registered on: 20/08/2024] Trial Registered Prospectively
Last Modified On: 19/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study To Know The Efficacy Of Katibasti With Agnitila In Gridhrasi (Sciatica) 
Scientific Title of Study   A Controlled Clinical Study On The Therapeutic Efficacy Of Katibasti With Agnitaila In Gridhrasi (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 Allappa Kumbar 
Designation  2nd year PG Scholar  
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital Bengaluru 
Address  Department of Panchakarma OPD no 14 and 26 Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital Anchepalya Bengaluru Karnataka 560074 India

Bangalore
KARNATAKA
560074
India 
Phone  7204742103  
Fax    
Email  draskumbar@sdmayurbangalore.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashanth Kumar 
Designation  Associate Professor  
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital 
Address  Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital OPD 14 and 26 Anchepalya Bengaluru

Bangalore
KARNATAKA
560074
India 
Phone  9844708874  
Fax    
Email  drpknrao@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prashanth Kumar 
Designation  Associate Professor  
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital 
Address  Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital OPD 14 and 26 Anchepalya Bengaluru

Bangalore
KARNATAKA
560074
India 
Phone  9844708874  
Fax    
Email  drpknrao@gmail.com  
 
Source of Monetary or Material Support  
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital Anchepalya Bengaluru 
 
Primary Sponsor  
Name  Dr Allappa Kumbar  
Address  Department of Panchakarma OPD no 14 and 26 Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital Anchepalya Bengaluru Karnataka 560074 India 
Type of Sponsor  Other [Self] 
 
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 Allappa Kumbar   Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital  Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital Anchepalya Bengaluru Department Of Panchakarma OPD 14 and 26
Bangalore
KARNATAKA 
7204742103

draskumbar@sdmayurbangalore.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital   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: charaka sutrastana 14 chapter, Procedure details: Katibasti with Agnitaila is done for 45 minutes per patient per day)
(1) Medicine Name: Agnitaila , Reference: Proprietary , Route: Topical, Dosage Form: Taila, Dose: 300(ml), Frequency: od, Duration: 10 Days
2Comparator ArmProcedure-kaTibastiH, कटिबस्तिः (Procedure Reference: Charaka sutrastana 14 chapter, Procedure details: katibasti with Nirgundi taila is done for 45 minutes per patient per day)
(1) Medicine Name: Nirgundi taila, Reference: Bhaishajya ratnavali Snehakalpana adhyaya, Route: Topical, Dosage Form: Taila, Dose: 300(ml), Frequency: od, Duration: 10 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1 Patients fulfilling the diagnostic criteria of Gridhrasi (Sciatica)
2 Age group 30-50 years
3 Patients with positive physical signs / special test of Sciatica
4 Patients who are voluntarily willing to sign consent form
 
 
ExclusionCriteria 
Details  1 Congenital deformities of the lumbar spine
2 Malignant conditions of the lumbar spine
3 Infective, inflammatory diseases of lumbar spine
4 Traumatic conditions of the lumbar spine like Compressive fractures, Quada equina compression
5 AVN head of femur
6 Pregnancy
7 Any other systemic illness like uncontrolled DM, HTN etc which interfering the treatment
8 Post-surgical conditions of lumbar spine.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in the clinical signs and symptoms of Gridhrasi
(Reduction in pain radiating from lower back along the pathway of sciatica nerve till the foot) 
Duration of study 10 days
Follow up 20th day
Total study period 20 days
1st assessment (before treatment)
2nd assessment 10th day(After Treatment)
Follow up 20th day(without assessment)
 
 
Secondary Outcome  
Outcome  TimePoints 
•Improvement in the functionality is assessed through Oswestry Disability Index (Questionnaire’s method)  1st assessment (before treatment)
2nd assessment 10th day(After Treatment)
Follow up 20th day
(without assessment)
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   10/09/2024 
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 - NO
Brief Summary  

Low Back Pain with sciatica is one of the most significant health problems in current-day practice. It also contributes to social life as well as economic crises in the form of deterioration in work productivity. Low back pain is the prime factor for disability & ranks 6th for the overall burden on the world population. The lifetime incidence of sciatica is reported to be between 10% to 40% and an annual incidence of 1% to 5%. The majority of incidence occurs in the 4th – 5th decade of the working population .

Gridhrasi is one among the Shoola pradhana vataja nanatmaja vyadhi  & it can be correlated to the disease Sciatica in contemporary science which can manifest as either Vataja type or Vatakaphaja  type. The common symptom seen as Kramatah shoola from Sphik, Kati, Prista, Uru, Janu, Jangha & Pada associated with Stambha, Toda, Muhur spandana & Sakthikshepa nigraha in Vataja type whereas in Kaphanubandhi type it is associated with Tandra, Gourava & Aruchi .

Sciatica is a debilitating condition that occurs most often due to herniation of a disc or an overgrowth of bone that puts pressure on part of the nerve which leads to low back pain that begins with the lumbosacral region and radiates along with the posterio-lateral aspects of the thigh to leg with difficulty in walking & paresthesia that travels along the path of the sciatica nerve. The management of sciatica includes analgesics, anti-inflammatory drugs, steroid injections & physiotherapy . Prolonged usage of these may lead to many adverse effects.

Ayurveda classics explain the treatment for Vatavyadhi in detail in which Snehana, Swedana & Mridu shodhan  are the prime line of treatment for vitiated Vatadosha. The Chikitsa sutra mentioned for Gridhrasi as Bastikarma, Siravyadha, Agnikarma & Virechana karma are considered as Vishesha chikitsa . The proper execution of these treatment principles will help in relieving the symptoms of the Gridhrasi.

Katibasti is a form of Snehayukta sweda and also Samshamaneeya bahirparimarjan chikitsa. The combination of Snehana & Swedana in Katibasti works together in relieving the Shoola, Stambha, etc. so that one can achieve symptomatic relief by increasing in functional ability of the affected region .

Agnitaila is a proprietary medicine and consists of ingredients like Tila, Punnaga, Nirgundi, Lavanga, Maricha, Lashuna & Sarshapa being Ushnaveerya dravya are having the Vatahara, Shoolahara, Stambhahara and also Kaphahara in action.

Nirgundi taila  consists of ingredients like Nirgundi, Langali & Tila being Ushnaveerya dravya having the Vatahara, Shoolahara, Stambhahara and also Kaphahara in action.

The Snehayukta sweda in the form of Katibasti may give significant relief in the treatment of Vatavyadhi. Hence an attempt is made to see the therapeutic efficacy of Katibasti with Agnitaila has been taken for the study.

 

 

 
Close