| CTRI Number |
CTRI/2024/12/078101 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of Viddhagnikarma and Agnikarma in the pain management of Sciatica |
|
Scientific Title of Study
|
AN OPEN LABEL CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECT OF VIDDHAGNI KARMA IN PAIN MANAGEMENT IN SCIATICA VIS-À-VIS GRIDHRASI. |
| 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 Shilpa P N |
| Designation |
PROFESSOR |
| Affiliation |
Government Ayurvedic Medical College.Bangalore. |
| Address |
OPD no 10.Department of shalyatantra .Government Ayurveda Medical College Bangalore -560009.
Bangalore KARNATAKA 560009 India |
| Phone |
9886792113 |
| Fax |
|
| Email |
drshilpamys@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Duragappa Harijana |
| Designation |
PhD scholar |
| Affiliation |
Government Ayurvedic Medical College.Bangalore. |
| Address |
OPD no 10, Department of shalya tantra. Government Ayurveda Medical College Bangalore -560009.
Bangalore KARNATAKA 560009 India |
| Phone |
9886102933 |
| Fax |
|
| Email |
durgeshhabalakatti@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Duragappa Harijana |
| Designation |
PhD scholar |
| Affiliation |
Government Ayurvedic Medical College.Bangalore. |
| Address |
OPD no 10.Department of shalyatantra .Government Ayurveda Medical College Bangalore -560009.
KARNATAKA 560009 India |
| Phone |
9886102933 |
| Fax |
|
| Email |
durgeshhabalakatti@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD no 10.Department of shalyatantra .Government Ayurveda Medical College Bangalore -560009. |
|
|
Primary Sponsor
|
| Name |
Dr Duragappa Harijana |
| Address |
Government Ayurveda Medical College Bangalore |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Dr Duragappa Harijana |
GOVERNMENT AYURVEDA MEDICAL COLLEGE |
OPD no 10 Department of shlaya tantra Bangalore KARNATAKA |
09886102933
durgeshhabalakatti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE GOVERNMENT AYURVEDA MEDICAL COLLEGE BANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•रà¥à¤® | (Procedure Reference: Su su 12, Procedure details: Weekly once )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1Selection of subject is done irrespective of gender, religion, occupation, socio economic and educational status.
2Subjects with classical features of Gridhrasi, namely pain over the Sphik (waist), Kati (back), Prishta (thigh), Uru (hip), Janu (knee), Jangha (calf region), extending up to Pada (foot). Stambh (stiffness), Toda (pricking pain), difficulty in walking etc. were included.
3Subjects with features of Sciatica |
|
| ExclusionCriteria |
| Details |
1.Cases of Spondylolisthesis, Sacroiliac arthritis, Herpese simplex infection causing radiating pain.
2.Tuberculoma, or any cyst compressing the nerve root, diabetic neuropathies are excluded,
People of Paittik constitution, where Agnikarma is contraindicated.
Debilated patients, patients below 18 yrs of age, patients affected with multiple wounds, 3.cases with destructed vertebral bodies and fractures of the vertebra were excluded..
4.Subject with any systemic disorder which may interfere with the course of treatment. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of pain ,stiffness, pricking sensation, twitching |
0th,7th,14th,28th,42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To enhance the quality of life by reducing the pain, dependency and improving the functionality |
0th,7th,14th,28th,42nd day |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
26/12/2024 |
| 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="5" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 (Sciatica) is one of the Vatavyadhi caused by aggravated Vatadosha. Included under 80 types of Vataj Nanatmaja Vyadhi. Gridhrasi consist of features like Ruk (continuous pain), Toda (intermittent pricking pain), Stambha (stiffness), Spandana (twitching sensation) over Sphik, Kati, Prishta, Uru, Janu, Jangha extending up to Pada. On the basis of symptoms,Gridhrasi can be clinically correlated with Sciatica. Sciatica occurs due to spinal nerve irritation and characterized by pain in the distribution of sciatic nerve. The lifetime incidence varying from 13-40% while the annual incidence of an episode of sciatica ranges between 1-5%. Peak incidence occurs in patient in their fourth decade Sciatica is a condition which incapacitates the patient to perform his daily routine activity due to continuous and stretching type of pain. Conservative management of sciatica încludes administration of NSAIDS, analgesics, muscle relaxant and corticosteroids which gives temporary relief. In some cases, if nerve compression is more, surgical procedure like Laminectomy, discectomy is indicated but this surgical procedure which are quite expensive with their limitations. Keeping in view about the adverse effects of the modern sciences, there is a need for review our science for an effective, economical, and simple short-term therapy with no side effects and non-recurrence in the management of Sciatica. In our Ayurvedic Science various modalities of treatment are explained for the management of Gridhrasi are Bheshaj, Snehana, Swedana, Siravyadhana, Agnikarma and Basti. Agni karma chikitsa is even indicated in various painful conditions like joint pain, headache, abdominal cramps/discomfort & few convulsive disorders like epilepsy, schizophrenia & phychosomatic disorders can be treated with this intentional heat burn therapy. In charkadatta & yogaratnakara we find direct reference of Agnikarma indicated for Gridhrasi. Agnikarma is the most important para surgical procedure. It is said to be better by virtue of its action. It is known to render quick relief. Moreover, Acharya Sushruta appreciates Apunarbhavarva as its prime quality, that means there is no recurrence of diseases treated by agnikarma. Thus it could be a potential area to explore in ayurvedic pain management. In classics, there are different types of agnikarma have been narrated. Among them Twak dagda & mamsa dagda are of therapeutic significance. The Mamsa dagda can be used for pathologies situated in deeper tissues such as asthi, snayu and sandhi. Based on the targeted area, different materials known as Dalhanopakarana are used to render the heat on effected tissue.For Mamsa dagda, Jambavoshta, loha shalaka, madhu, Sneha, guda and Suchi are advised as choice of material by Vagbhata. Acharya Vangasena has specified agnikarma with suchi as the treatment modality of Gridhrasi. Compared the classical agnikarma using shalaka, suchi renders deeper penetration and minimal scar. Moreover, its easy availability, inexpensiveness, early heating and better cosmetic outcomes makes it better choice.. To make the method user friendly by avoiding repeated heating, procedure is modified with the support of advanced technology. Viddha karma is one of the eight Shashtra karma mentioned by Acharya Sushruta Here Suchi in the form of hollow needle will be heated using a cautery machine, which is practiced as Viddhagni. This procedure ensures the heat delivery to the targeted deeper tissue with better cosmetic outcomes. Hence this innovative, improved and user-friendly procedure is adopted for the study. Hence, the current work is intended to manage Sciatica, a condition which causes significant clinical and public health burdens by exploring effective, safe and cost-effective method of treatment using principles of agnikarma. Also adopting the agnikarma with suchi and modifying it as viddhagni appears to be the best line of intervention in pain management. Thus, the present study is intended to evaluate the effect of viddhagni karma in subjects fulfilling the criteria of Sciatica vis a vis Gridhrasi. |