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CTRI Number  CTRI/2023/07/055192 [Registered on: 13/07/2023] Trial Registered Prospectively
Last Modified On: 07/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Viddhakarma and Agnikarma in pain management of Gridhrasi (sciatica) 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of Viddhakarma and Agnikarma in pain management of 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 HARVEER SINGH SANGWA 
Designation  MS SCHOLAR 
Affiliation  Post Graduate Institute Of Ayurveda dsrrau Jodhpur 
Address  Room No 135 PG Department of Shalya Tantra Post Graduate Institute Of Ayurveda Dsrrau Jodhpur RAJASTHAN

Jodhpur
RAJASTHAN
342037
India 
Phone  9460653109  
Fax    
Email  sangwaharveer0@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PROF Dr RAJESH KUMAR GUPTA 
Designation  Professor and HOD of Shalya Tantra Department 
Affiliation  Post Graduate Institute Of Ayurveda dsrrau Jodhpur 
Address  Room No 135 PG Department of Shalya Tantra Post Graduate Institute Of Ayurveda Dsrrau Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9636520573  
Fax    
Email  guptadrrajeshkumargupta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  PROF Dr RAJESH KUMAR GUPTA 
Designation  Professor and HOD of Shalya Tantra Department 
Affiliation  Post Graduate Institute Of Ayurveda dsrrau Jodhpur 
Address  Room No 135 PG Department of Shalya Tantra Post Graduate Institute Of Ayurveda Dsrrau Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9636520573  
Fax    
Email  guptadrrajeshkumargupta@gmail.com  
 
Source of Monetary or Material Support  
OPd No 14 PG Dept of Shalya Tantra Sanjeevni hospital DSRRAU Jodhpur Rajasthan 
 
Primary Sponsor  
Name  Post Graduate Institute of Ayurved Jodhpur 
Address  Post Graduate Institute of Ayurved Joshpur Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan 
Type of Sponsor  Government funding agency 
 
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 
Prof Dr Rajesh kumar gupta  Sanjeevni Hospital DSRRAU Jodhpur  OPd No 14 PG Dept of Shalya Tantra Sanjeevni Hospital DSRRAU Jodhpur Rajasthan
Jodhpur
RAJASTHAN 
9636520573

guptadrrajeshkumargupta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE POST GRADUATE INSTITUE OF AYURVEDA JODHPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vedhana-karma, वेधन-कर्म (Procedure Reference: susrut sutra 5/5, Procedure details: 1/weeks)
2Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: CHARAK CHIKITSA 28/10, Procedure details: WEEKLY)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Patient who will give written consent.
2 Patients of either sex in the 20 Years to 70 years age group.
3 Diagnosed cases of Gridhrasi with symptoms like Ruja, Stambha, Suptata, Spandana, Tandra,Gaurav, Arochak Sign like Sakthi nikshepa nigraha (SLR, i.e., straight leg rising test positive)
 
 
ExclusionCriteria 
Details  1 Patient suffering from AIDS and Hepatitis B.
2 Fracture related to spine
3 Patient related with any malignancy of spine or other organ.
4 Patient suffering from uncontrolled diabetes and Tuberculosis of spine And hip joint. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluate & compare the effect of Agnikarma and viddhakarma in the pain
management of Gridhrasi (sciatica).

 
4 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Contemporary & comprehensive study of the related problem.  4 weeks 
 
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   Phase 2 
Date of First Enrollment (India)   24/07/2023 
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="0"
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  

Pain is the chief cause of visiting a doctor in most patients. It is known as Ruja which is one of the synonyms of disease. It disturbs physical and mental status of a patient. Pain is cardinal symptom in most of the Vatavyadhis. Gridhrasi is such a Ruja Pradhaana Vatavyadhi. In Gridhrasi intense shooting pain characteristically radiates from Sphika (gluteal region) to Pada (foot).

पाष्निप्रत्यंगुलिनां तु कडरा याऽनिलार्दिता |

सक्थन: क्षेपं निगृहीयाद् गृध्रसीति हि सा स्मृता || सु नि १/७४                                                  

   à¤¸à¥à¤«à¤¿à¤•पूर्वा कटिपृष्ठोरुजानुजंघापदं  à¤•्रमात || च चि. .२८/५६

On the basis of symptoms of Gridhrasi, it can be equated with the disease sciatica in modern science. It occurs due to spinal nerve irritation and is characterized by pain in distribution of sciatic nerve. Low back pain and radiating pain due to lumbar disc prolapse are the major cause of morbidity throughout the world. Lifetime incidence of low back pain is 50‐70% with incidence of sciatica more than 40%. However sciatica due to lumbar disc prolapse occurs only in 4‐6% of the population. Hence this is a significant threat to working population. It disturbs daily routine and overall life of the patients because of continuous and stretching type of pain. In reference to sciatica treatment; medical science has only symptomatic management with analgesic like non‐steroidal anti‐inflammatory drugs. In some cases if nerve compression is more; surgical procedures like laminectomy, discectomy are indicated but these surgical procedures are expensive with their limitations. In Ayurveda, various methods used in the treatment of Gridhrasi are; Bheshaja, Snehana, Swedana, Siravedha, Agnikarma and Basti.

                                                   अन्तरा कंडरागुल्फं सिरा बस्त्यग्निकर्म च |  च.चि.२८/१०

 In today’s era quick pain relief is of prime importance to resume normal activities. Hence Agnikarma (therapeutic intentional burn) and veddha are considered as instant healers of pain. Agnikarma and veddha have been proved to be effective in Ruja Pradhaan Vatavyadhis. Sushruta has mentioned Agnikarma and Siravedha as para‐surgical procedures in Gridhrasi as superior to other treatment modalities.

                            अष्टविध शस्त्रकर्माष्टविधम् । तद्यथा-छेद्यं भेद्यं लेख्यं वेध्यं एष्यं आहार्यं विस्त्राव्यं सीव्यमिति ॥ सु .सू .५/५

                                                  à¤•ुठारिकाव्रीहीमुखारवेतसपत्रकाणि व्यधने सुची च । सु.सू.८/४

 METHODS

Purvakarma

Before procedure informed written consent will be taken. Injection TT 0.5 CC Intramuscular will be given, if not taken in early 6 months. Whole procedure will be described to patient in detail and assured in their own language. CBC, BT, CT, HIV, HbsAg, random Blood sugar level etc routine blood investigation will be done before procedure.

 Pradhankarma

·       Points will be marked on four fingers above or below the knee joint by skin marker And as per need, tender points will be  marked by marker. The sites then will be cleaned with spirit swab. With the help of disposable needle no.26 tender points will be  pierced  and upto depth 3-4 mm. The needle will be placed in the same position for 1 minute and then took out.

·       The loha Shalaka will be heated to red hot over the flame of the heating device. The Staff Nurse will be  advised to hold the affected limb in suitable position. Later Agnikarma will be performed with Red Hot Shalaka in Binduakriti at mark points in such a way that Samyakdagdha lakshanas will be observed.

Pashchatkarma

 The sites then clean with plane gauze piece. Same procedure will be done on 7,14,21 days upto 1 month  for desirable results.

MATERIALS

 

Loha Shalakas for Agnikarma, lamp, raw Aloevera and Disposable needle no. 26, sprit swab  

METHODS

Purvakarma

Before procedure informed written consent will be taken. Injection TT 0.5 CC Intramuscular will be given, if not taken in early 6 months. Whole procedure will be described to patient in detail and assured in their own language. CBC, BT, CT, HIV, HbsAg, random Blood sugar level etc routine blood investigation will be done before procedure.

 Pradhankarma

·       Points will be marked on four fingers above or below the knee joint by skin marker And as per need, tender points will be  marked by marker. The sites then will be cleaned with spirit swab. With the help of disposable needle no.26 tender points will be  pierced  and upto depth 3-4 mm. The needle will be placed in the same position for 1 minute and then took out.

·       The loha Shalaka will be heated to red hot over the flame of the heating device. The Staff Nurse will be  advised to hold the affected limb in suitable position. Later Agnikarma will be performed with Red Hot Shalaka in Binduakriti at mark points in such a way that Samyakdagdha lakshanas will be observed.

Pashchatkarma

 The sites then clean with plane gauze piece. Same procedure will be done on 7,14,21 days upto 1 month  for desirable results.

MATERIALS

 

Loha Shalakas for Agnikarma, lamp, raw Aloevera and Disposable needle no. 26, sprit swab 

 
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