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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | vedhana-karma, वेधन-करà¥à¤® | (Procedure Reference: susrut sutra 5/5, Procedure details: 1/weeks)
| 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•रà¥à¤® | (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).
पाषà¥à¤¨à¤¿à¤ªà¥à¤°à¤¤à¥à¤¯à¤‚गà¥à¤²à¤¿à¤¨à¤¾à¤‚
तॠकडरा याऽनिलारà¥à¤¦à¤¿à¤¤à¤¾ |
सकà¥à¤¥à¤¨:
कà¥à¤·à¥‡à¤ªà¤‚ निगृहीयादॠगृधà¥à¤°à¤¸à¥€à¤¤à¤¿ हि सा सà¥à¤®à¥ƒà¤¤à¤¾ || सॠनि १/à¥à¥ª
सà¥à¤«à¤¿à¤•पूरà¥à¤µà¤¾
कटिपृषà¥à¤ ोरà¥à¤œà¤¾à¤¨à¥à¤œà¤‚घापदं कà¥à¤°à¤®à¤¾à¤¤
|| 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 50â€70% with incidence of sciatica more than 40%. However sciatica due to lumbar
disc prolapse occurs only in 4â€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
nonâ€steroidal antiâ€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.
अनà¥à¤¤à¤°à¤¾ कंडरागà¥à¤²à¥à¤«à¤‚ सिरा बसà¥à¤¤à¥à¤¯à¤—à¥à¤¨à¤¿à¤•रà¥à¤®
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 paraâ€surgical
procedures in Gridhrasi as superior to other treatment modalities.
अषà¥à¤Ÿà¤µà¤¿à¤§ शसà¥à¤¤à¥à¤°à¤•रà¥à¤®à¤¾à¤·à¥à¤Ÿà¤µà¤¿à¤§à¤®à¥ । तदà¥à¤¯à¤¥à¤¾-छेदà¥à¤¯à¤‚ à¤à¥‡à¤¦à¥à¤¯à¤‚ लेखà¥à¤¯à¤‚ वेधà¥à¤¯à¤‚ à¤à¤·à¥à¤¯à¤‚ आहारà¥à¤¯à¤‚
विसà¥à¤¤à¥à¤°à¤¾à¤µà¥à¤¯à¤‚ सीवà¥à¤¯à¤®à¤¿à¤¤à¤¿ ॥ सॠ.सू .५/५
कà¥à¤ ारिकावà¥à¤°à¥€à¤¹à¥€à¤®à¥à¤–ारवेतसपतà¥à¤°à¤•ाणि
वà¥à¤¯à¤§à¤¨à¥‡ सà¥à¤šà¥€ च । सà¥.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 |