| CTRI Number |
CTRI/2026/03/105452 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Siravyadha & Agnikarma in the management of Gridhrasi (Sciatica) |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the role of Siravyadha & Agnikarma in the management of Gridhrasi Rog w.s.r. to 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 |
Mohd Faisal Aalam |
| Designation |
PG Scholar |
| Affiliation |
Shri Dhanwantri Ayurvedic Medical College and Research Centre |
| Address |
Shri Dhanwantri Ayurvedic Medical College and Research Centre
27km Milestone Mathura Delhi Highway Chhata Mathura U.P. India 281401
Boys Hostel
Department of Shalya Tantra
Ground floor Room no.- 05
Muzaffarnagar
UTTAR PRADESH
251311
India |
| Phone |
9897792999 |
| Fax |
|
| Email |
faisalgaur@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Kumar |
| Designation |
Professor |
| Affiliation |
Shri Dhanwantri Ayurvedic Medical College and Research Centre |
| Address |
Shri Dhanwantri Ayurvedic Medical College and Research Centre
27km Milestone Mathura Delhi Highway Chhata Mathura U.P. India 281401
Mathura
UTTAR PRADESH
281401
India |
| Phone |
9266949403 |
| Fax |
|
| Email |
directorsdamcrc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Kumar |
| Designation |
Professor |
| Affiliation |
Shri Dhanwantri Ayurvedic Medical College and Research Centre |
| Address |
Shri Dhanwantri Ayurvedic Medical College and Research Centre
27km Milestone Mathura Delhi Highway Chhata Mathura U.P. India 281401
Mathura
UTTAR PRADESH
281401
India |
| Phone |
9266949403 |
| Fax |
|
| Email |
directorsdamcrc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri dhanwantri ayurvedic medical college and research centre 27km milestone mathura delhi highway chhata mathura u.p. 281401 |
|
|
Primary Sponsor
|
| Name |
Shri Dhanwantri Ayurvedic Medical College and Research Centre |
| Address |
Shri Dhanwantri Ayurvedic Medical College and Research Centre 27km Milestone Mathura Delhi Highway Chhata Mathura U.P. India 281401
27km Milestone Mathura Delhi Highway Chhata Mathura U.P. India 281401 |
| Type of Sponsor |
Private medical college |
|
|
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 Mohd Faisal Aalam |
Shri Dhanwantri Ayurvedic Medical College and Research Centre |
Shri Dhanwantri Ayurvedic Medical College and Research Centre
27km Milestone Mathura Delhi Highway Chhata Mathura U.P. India 281401
Department of Shalya Tantra
Ground Floor Room no. - 05
Mathura
UTTAR PRADESH |
9897792999
faisalgaur@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Dhanwantri Ayurvedic Medical College and Research Centre |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: Charaka Sanhita, Procedure details: Siravyadha procedure will be performed below Janu Sandhi (knee region) using scalp vein set (20G) under aseptic precautions. Approximately 30–60 ml bloodletting will be done per sitting. The procedure will be performed once weekly for 1 month.)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Chakradatta, Procedure details: Agnikarma will be performed using red hot Panchadhatu Shalaka at Padakanisthaka Sthana (little toe region) under aseptic precautions. The procedure will be performed once weekly for 1 month.)
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 25 to 65 years
Diagnosed cases of Gridhrasi
Both sexes
Willing to participate
|
|
| ExclusionCriteria |
| Details |
UNCONTROLLED DIABETES MELLITUS
Severe Cardiac Disease
Pregnancy
Hb less than 7 |
|
|
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 score and improvement in SLR test |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in stiffness, numbness & heaviness. at day 7, 14, 21, 28 |
At day 7, 14, 21, 28 for 1 month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2026 |
| 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 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 randomized open label comparative clinical study will be conducted to evaluate the effect of Siravyadha and Agnikarma in the management of Gridhrasi (Sciatica). Gridhrasi is a Vata dominant disorder characterized by radiating pain from low back to lower limb similar to sciatica. Total 80 patients fulfilling the inclusion criteria will be randomly divided into two groups. Group A will be treated with Siravyadha and Group B will be treated with Agnikarma once weekly for four weeks. Assessment will be done on the basis of subjective parameters like pain, stiffness, numbness and objective parameter like SLR test. Follow up will be done on day 7, 14, 21 and 28. The collected data will be statistically analyzed to compare the efficacy of both procedures. |