| CTRI Number |
CTRI/2023/07/054995 [Registered on: 10/07/2023] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Para Surgical procedure] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical study to know the effect of Agnikarma with Tamra shalaka and to compare with Siravyadhana in the management of Gridrasi(Sciatica) along with Trayodashanaga guggulu in both groups |
|
Scientific Title of Study
|
A Randomized Comparitive Clinical study to evaluate the effect of Agnikarma with Tamra shalaka over Siravyadhana along with Trayodashanga guggulu in the management of Gridrasi with special reference to Sciatica |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hittinahalli Santhosh |
| Designation |
2nd year PG scholar |
| Affiliation |
BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA |
| Address |
Dr Hittinahalli Santhosh
2nd year PG scholar
Department of PG studies in Shalyatantra
BLDEAs AVS Ayurveda Mahavidyalaya Vijayapura
Bijapur
KARNATAKA
586109
India |
| Phone |
9008598796 |
| Fax |
|
| Email |
santoshhittinahalli90085@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasadshakti G Ganuur |
| Designation |
Professor and HOD |
| Affiliation |
BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA |
| Address |
Dr Prasadshakti G Gannur
Professor and HOD
Department of PG studies in Shalyatantra
BLDEAs AVS Ayurveda Mahavidyalaya Vijayapura
Bijapur
KARNATAKA
586109
India |
| Phone |
9480062140 |
| Fax |
|
| Email |
pgannur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasadshakti G Ganuur |
| Designation |
Professor and HOD |
| Affiliation |
BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA |
| Address |
Dr Prasadshakti G Gannur
Professor and HOD
Department of PG studies in Shalyatantra
BLDEAs AVS Ayurveda Mahavidyalaya Vijayapura
Bijapur
KARNATAKA
586109
India |
| Phone |
9480062140 |
| Fax |
|
| Email |
pgannur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalyatantra OPD and IPD BLDEAs AVS Ayurveda Mahavidyalaya
Vijayapura
Pincode 586109
Karnataka |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Hittinahalli Santhosh |
BLDEAs AVS Ayurveda Mahavidyalaya Vijayapura |
Department of Shalyatantra
BLDEAs AVS Ayurveda Mahavdyalaya
Vijayapur
Bijapur
KARNATAKA |
9008598796
santoshhittinahalli90085@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta Samhita, Procedure details: Prior to procedure patient advised to take snigdha and picchila ahara. Preparation of part. Tamra Shalaka is heated to red hot and Samyagdagdha Agnikarma will be made in Bindu dahana vishesha. After procedure Sarpi and madhu are applied over agnikarma site)
(1) Medicine Name: Trayodashanga Guggulu, Reference: Bhaishaja Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: Sushruta Samhita, Procedure details: Prior to the procedure Tila Yavgau paana advised. Sthanika Abhyanga and sweda done.Under aseptic precautions Siravyadhana performed.After bleeding stops bandaging will be done)
(1) Medicine Name: Trayodashanga Guggulu, Reference: Bhaishaja Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18 to 70 years
No discrimination of sex
Patient with pratyatma lakshana of Gridrasi i.e sphik,purva,kati,prushta,uru,janu,jangha,pada kramat vedana,sthamba,toda |
|
| ExclusionCriteria |
| Details |
Trauma of lumbar vertebra
Fracture of spine
Uncontrolled case of Diabetes Mellitus
Patient having lumbar canal stenosis
3rd and 4th degree disc prolapse
Patients with HIV HbsAg HCV
Pregnant women
Unfit for Siravyadhana
Any systemic disorder which will interfere the treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from pain |
Relief from pain |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from numbness |
30 days |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
21/07/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is A comparitive clinical study to evaluate the effect of Agnikarma with Tamra shalaka over Siravyadhana along with Trayodashanaga guggulu in the management of Gridrasi with special reference to Sciatica in BLDEAs AVS Ayurveda Mahavidyalaya Vijayapura |