| CTRI Number |
CTRI/2023/09/057568 [Registered on: 13/09/2023] Trial Registered Prospectively |
| Last Modified On: |
06/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management of pain in sciatica(Gridhrasi) using modified thermal therapy(Viddhaagnikarma) |
|
Scientific Title of Study
|
A Randomized Open Labelled Controlled Clinical study to Evaluate the Effectiveness of Viddhagnikarma in the Management of Pain in Gridhrasi with special reference to Dermatomes |
| 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 Afra Eiram |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room number 207, Department of PG studies in Shalya Tantra, Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura Road, Udayapura Post, Bengaluru.
Bangalore
KARNATAKA
560082
India |
| Phone |
8884042992 |
| Fax |
|
| Email |
dr.afraeiram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muralidhara N |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room number 207, Department of PG studies in Shalya Tantra, Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura Road, Udayapura Post, Bengaluru.
Bangalore
KARNATAKA
560082
India |
| Phone |
9845895455 |
| Fax |
|
| Email |
aisriktk@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muralidhara N |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room number 207, Department of PG studies in Shalya Tantra, Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura Road, Udayapura Post, Bengaluru.
Bangalore
KARNATAKA
560082
India |
| Phone |
9845895455 |
| Fax |
|
| Email |
aisriktk@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research,21st KM, Kanakapura Road,Uadayapura
Post, Bengaluru 560082 |
|
|
Primary Sponsor
|
| Name |
Dr Afra Eiram |
| Address |
Room number 207, Department of PG studies in Shalya Tantra, Sri Sri College of Ayurvedic Science and Research, 21st KM, Kanakapura Road, Udayapura Post, Bengaluru. |
| 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 Afra Eiram |
Sri Sri College of Ayurvedic Science and Research hospital |
Room number 207, Department of PG studies in Shalya Tantra,Sri
Sri College of Ayurvedic Science and Research,21st KM,
Kanakapura Road,Udayapura Post, Bengaluru.
Bangalore
KARNATAKA |
8884042992
dr.afraeiram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUITIONAL ETHICAL 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 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushrutha Samhita , Procedure details: Sarjarasa agnikarma on 1st 7th 14th and 21st day over the affected dermatomes
)
| | 2 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Astanga Sangraha , Procedure details: Viddhaagnikarma will be performed on 1st 7th 14th & 21st day using 26 1 and 1/2 gauged needle and electrocautery )
|
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fulfilling the Diagnostic criteria.
Subjects who will be on analgesics will be included in the study with a washout period of 3days |
|
| ExclusionCriteria |
| Details |
Subjects with infective, neoplastic or inflammatory conditions of the spine that mimics
Sciatica.
Subjects who have an ongoing infection and are on antibiotics.
Subjects with traumatic injuries of the spine.
Subjects with systemic disorders which can interfere with the intervention.
Subjects with any metallic implants.
Subjects with loss of anal sphincter tone and difficulty in micturition.
Subjects who are pregnant. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain |
1st 7th 14th & 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved gait & range of movement |
28th & 35th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
16/09/2023 |
| 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="1"
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
|
THIS STUDY IS PUT FORWARD TO EVALUATE THE EFFECTIVENESS OF VIDDHAGNIKARMA IN THE MANAGEMENT OF PAIN IN GRIDHRASI WITH SPECIAL REFERENCE TO DERMATOMES IN
COMPARISON WITH SARJARASA AGNIKARMA INORDER TO HELP THE AILING PATIENTS , WITH PAIN MODERATION AND IMPROVE THEIR QUALITY OF LIFE BY PREVENTING DEPENDENCY ON ANALGESICS AND THEIR ADVERSE EFFECTS..
HYPOTHESIS
NULL HYPOTHESIS:
H0 : There is no significant difference in the effectiveness of Viddha Agnikarma and Sarjarasa Agnikarma in the management of pain in Gridhrasi.
ALTERNATE HYPOTHESIS:
H1 : Viddha Agnikarma is more effective over Sarjarasa Agnikarma in the management of pain in Gridhrasi. |