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CTRI Number  CTRI/2025/02/081480 [Registered on: 28/02/2025] Trial Registered Prospectively
Last Modified On: 28/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison on effectiveness of chinchapinda sweda and patrapinda sweda in Gridrasi - Sciatica  
Scientific Title of Study   Efficacy of Chinchapinda sweda in comparison to Patrapinda sweda in Gridhrasi - Sciatica -A Randomized Clinical Trail 
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 Ramanagouda 
Designation  2nd year PG scholar 
Affiliation  Department of Panchakarma Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital 
Address  Department of Panchakarma Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital OPD 14 and 26

Bangalore
KARNATAKA
560074
India 
Phone  9110281577  
Fax    
Email  ramanagowdab.hosmani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashanth kumar 
Designation  Associate professor  
Affiliation  Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital  
Address  Department of Panchakarma Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital OPD 14

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 Manjunateshwara institute of Ayurveda and Hospital  
Address  Department of Panchakarma Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital OPD 14

Bangalore
KARNATAKA
560074
India 
Phone  9844708874  
Fax    
Email  drpknrao@gmail.com  
 
Source of Monetary or Material Support  
Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital anchepalya kumbalagodu post bangalore 560074 karnataka india  
 
Primary Sponsor  
Name  Dr Ramanagouda 
Address  Department of Panchakarma Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital OPD 14 and 26 Anchepalya Bangalore karnataka 560074 
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 Ramanagouda  Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital   Department of Panchakarma OPD 14 and OPD 26
Bangalore
KARNATAKA 
9110281577

ramanagowdab.hosmani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Shri Dharmasthala Manjunateshwara 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:7||Osteopathic. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-svedanam, स्वेदनम् (Procedure Reference: Charaka Sutra Sthana Sweda Adhyaya, Procedure details: Heat herbal Pottali. Then the heat is applied to the patient body for Swedana over the low back & both legs, continued about 45 minutes duration )
2Comparator ArmProcedure-svedanam, स्वेदनम् (Procedure Reference: Charaka Samhita Sutra Sthana Swedana Adhyaya, Procedure details: Heat herbal Pottali. Then the heat is applied to the patient body for Swedana over the low back & both legs, continued about 45 minutes duration)
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients fulfilling the diagnostic criteria of Gridhrasi (Sciatica).
2. Patients of either gender between age group 30-60 years
3. Patients with positive physical signs & special test of Sciatica.
4. Patients who are willing for consent 
 
ExclusionCriteria 
Details  1. Congenital deformities of the spine
2. Malignant conditions of the spine
3. Infective, inflammatory diseases of 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, which interfering the treatment
7.Post-surgical conditions of lumbar spine
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Improvement in the clinical signs & symptoms of Gridhrasi - Sciatica is assessed through Clinical Gradings.
2. Reduction in the Pain is assessed by using VAS scale.
3. Improvement in Objective parameters is assessed by SLR test.
 
0th day - before treatment
10th day - after treatment
20th day - follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the functionality is assessed through Oswestry Disability Index (Questionnaire’s method).  0th day (before treatment)
10th day (after treatment)
20th day ( follow up) 
 
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)   11/03/2025 
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 - NO
Brief Summary  

Low back pain is one of the common conditions of musculoskeletal disorder, affects people during their productive life. About 40% cases of Low back pain are of radicular in origin and considered under the Sciatic syndrome. Gridhrasi is one of the most common disorders of Vata, which closely resembles with Sciatica, which is characterized by pain or discomfort associated with Sciatic nerve. The prevalence of Sciatica varies considerably ranging from 13% to 40%, the corresponding annual incidence of an episode of Sciatica ranges from 1% to 5%. Contemporary medicine has limitations giving short-term relief in pain or surgical intervention with less desired effect.

Sciatica is a debilitating condition characterized by pain and paresthesia with in the sciatic nerve distribution or associated lumbosacral nerve root 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.

Gridhrasi is one among the vataja nanatmaja vyadhi which can manifest as either Vataja type or Vatakaphaja type and it can be correlated to the disease Sciatica in contemporary science. The common symptoms are 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 Kaphanubandhí type it is associated with Tandra, Gourava & Aruchi .

Snehana, Swedana and Mrudu Shodhana described as treatment principle of Vatavyadhi . Pinda Sweda like Patrapinda or Chinchapinda are types of Swedana which are beneficial in treating Vataja and Vata-kaphaja vyadhi. Patrapinda Sweda which contains drugs like Patras of Eranda, Nirgundi etc used in the form of Pottali and acts as Vatahara, Shoolahara, Stambhahara. Chincha (Ripened fruit pulp) is considered to be vatahara and kaphahara which can be used in the form of Pinda sweda may have beneficial effect on vatavyadhi in relieving the symptoms. Both these therapies are having their own significant actions based upon the selection of drugs and also mode of usage of therapy. 

 
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