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CTRI Number  CTRI/2024/07/070110 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 08/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of Agnikarma in the pain management of Gridhrasi (Sciatica) 
Scientific Title of Study   A Randomized Comparative Clinical Trial to evaluate the efficacy of Agnikarma in the pain management of Gridhrasi with special reference to Sciatica according to Sushruta Samhita and Harita Samhita. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  DR BOGANATHAM VENKATA SUMANJALI  
Designation  PG Scholar  
Affiliation  BVVS Ayurved Medical College and Hospital Bagalkot 
Address  Department of PG Studies in Shalya Tantra BVVS Ayurved Medical College and Hospital BVVS Old Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  9035192082  
Fax    
Email  sumanjalibala@gmail.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Pallavi A Hegde 
Designation  Professor 
Affiliation  BVVS Ayurved Medical College and Hospital Bagalkot 
Address  Department of PG Studies in Shalya Tantra BVVS Ayurved Medical College and Hospital BVVS Old Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  9448636321  
Fax    
Email  drpallaviah@rediffmail.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Dr Pallavi A Hegde 
Designation  Professor 
Affiliation  BVVS Ayurved Medical College and Hospital Bagalkot 
Address  Department of PG Studies in Shalya Tantra BVVS Ayurved Medical College and Hospital BVVS Old Campus Bagalkot

Bagalkot
KARNATAKA
587101
India 
Phone  9448636321  
Fax    
Email  drpallaviah@rediffmail.com  
 
Source of Monetary or Material Support  
BVVS Ayurved Medical College and Hospital, Bagalkot, KArnataka - 587101 
 
Primary Sponsor
Modification(s)  
Name  BVVS Ayurved Medical College and Hospital 
Address  BVVS Ayurved Medical College and Hospital BVVS campus old bus stand road Bagalkot Karnataka 587101  
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 B V Sumanjali  BVVS Ayurved Medical College and Hospital  Shalyatantra OPD Room No: 03 BVVS Ayurved Medical College and Hospital Bagalkot KARNATAKA
Bagalkot
KARNATAKA 
9035192082

sumanjalibala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC BVVS AYURVED MEDICAL COLLEGE AND HOSPITAL,BAGALKOT,KARNATAK  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-agnikarma, अग्निकर्म (Procedure Reference: Haritha Samhitha, Procedure details: Bindu rupi Agnikarma with panchaloha shalaka will be performed on 4 angula above gulpha sandhi till samyak dagdha laxanas are seen. Once in a week for 3 weeks.)
2Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushruta samhita, Procedure details: Bindu rupi Agnikarma will be performed with panchaloha shalaka on atiugra ruja sthana till samyak dagdha lakhanas are seen. Once in a week for 3 weeks.)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  •Presence of Ruk, Toda, Stambha in the Sphik, Kati, Uru, Janu, Jangha, Pada.
•Patients with controlled Diabetes Mellitus and Hypertension. 
 
ExclusionCriteria 
Details  •Patient with Traumatic paraplegia, Paraplegia, Hemiplegia, other Tumors of spine, Bowel & Bladder incontinence, TB of spine, Congenital anomalies.
•Patient with history of Fractures and traumatic injuries of hip joint.
• Pregnant women and Lactating women.
• Patients who are Anarha for Agnikarma.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in pain  21days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in stiffness  21 days 
 
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   N/A 
Date of First Enrollment (India)   15/07/2024 
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  

              Gridhrasi is a condition in which Vata getting aggravated due to Nidana Sevana, invades the Kandaras of the Parshni (ankle) and Pratyanguli (toes), and produces Kshepa (pain and inability to extend) in the Sakthi (thighs) . Acharya Harita explained about Gridhrasi, where Vedana (pain) is the main feature in Kati, Uru, Jangha and Janu Pradesha and according to Acharya Charaka it is a disorder in which Ruk (pain), Toda (pricking pain) and Stambha (stiffness) are the main features where pain starts from Sphik Pradesha (lower back) and radiates downwards to Kati, Prusta, Uru, Janu, Jangha and Pada.

In Sciatica, symptoms like pain and stiffness which starts from the lower back region and radiates down to one or both lower limbs. The pain is distributed along the sciatic nerve. Thus the disease Gridhrasi can be correlated to Sciatica. In the contemporary science, pain is managed by the administration of muscle relaxants, NSAIDs, corticosteroids etc. Long term usage of these medicines may cause mild to serious systemic illness.

Prevalence ranging from 2–5%, depending on the population. Lifetime incidence is reported to be between 10% to 40% and an annual incidence of 1 to 5% in India. It rarely occurs before age 20 unless secondary to trauma. There is no association with body weight or height except in 50 years to 60 years age group.

In Ayurveda, Gridhrasi is treated with Bheshaja, Siravyadhana, Bastikarma and Agnikarma. Acharya Sushruta explained the importance of Agnikarma which can be performed at Atiugraruja Sthana of Twacha, Mamsa, Sira, Snayu, Sandhi and Asthi Vikaras and according to Acharya Harita, Gridhrasi is a condition which is managed by Agnikarma at Gulpha Chaturangule.

   Thus the study is undertaken to evaluate the pain management efficacy of Agnikarma with Panchaloha Shalaka in Gridhrasi with special reference to Sciatica on two different sites explained by Acharya Sushruta and Acharya Harita.

 

 

 
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