| CTRI Number |
CTRI/2025/09/094876 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Agnikarma by Mitti shalaka and shiva gugglu drug in Back pain (Sciatica) |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF AGNIKARMA AND SHIVA GUGGULU IN 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 Vimal Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Rishikul Ayurvedic College, Uau, Dehradun |
| Address |
OPD NO.7,Deptt of Shalya Tantra, Rishikul Ayurved hospital,Rishikul Campus, Uttarakhand Ayurved University, Haridwar Uttarakhand 249401 India
PD NO.7,Deptt of Shalya Tantra, Rishikul Ayurved hospital,Rishikul Campus, Uttarakhand Ayurved University, Haridwar Uttarakhand 249401 India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9415812272 |
| Fax |
|
| Email |
imsvimal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vimal Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Rishikul Ayurvedic College, Uau, Dehradun |
| Address |
OPD NO.7,Deptt of Shalya Tantra, Rishikul Ayurved hospital,Rishikul Campus, Uttarakhand Ayurved University, Haridwar Uttarakhand 249401 India
PD NO.7,Deptt of Shalya Tantra, Rishikul Ayurved hospital,Rishikul Campus, Uttarakhand Ayurved University, Haridwar Uttarakhand 249401 India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9415812272 |
| Fax |
|
| Email |
imsvimal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akansha negi |
| Designation |
PG Scholar |
| Affiliation |
Rishikul Ayurvedic College, Uau, Dehradun |
| Address |
OPD NO.7,Deptt of Shalya Tantra, Rishikul Ayurved hospital,Rishikul Campus, Uttarakhand Ayurved University, Haridwar Uttarakhand 249401 India
OPD NO.7,Deptt of Shalya Tantra, Rishikul Ayurved hospital,Rishikul Campus, Uttarakhand Ayurved University, Haridwar Uttarakhand 249401 India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7830789786 |
| Fax |
|
| Email |
akanshanegi36@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No. 7, Deptt. of Shalya Tantra, Rishikul Ayurved hospital, Rishikul Campus, Uttarakhand
Ayurved University, Haridwar Uttarakhand 249401 India |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved university |
| Address |
Uttarakhand Ayurved university, Railway Road, Harrawala, Dehradun |
| Type of Sponsor |
Government 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 |
| Akansha Negi |
Rishikul Campus,Uttarakhand Ayurved University Haridwa |
OPD No. 7, Deptt. of
Shalya Tantra, Rishikul
Ayurved hospital,
Rishikul Campus,
Uttarakhand Ayurved
University, Haridwar
Hardwar Uttarakhand
249401 India
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL |
07830789786
akanshanegi36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttarakhand Ayurved University, Rishikul Campus, Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: VATAKAPAJA-GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SHIVA GUGGULU, Reference: Rasendrasaarsanghrah, Route: Oral, Dosage Form: Guggulu , Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushurut samhita sutra 12/4, Procedure details: - After explaining about the whole procedure of Agnikarma to the patient, informed written consent will be taken.
- Painful, tender points will be marked with marker.
- The procedure will be done with red Mrittika shalaka at the marked site for just 1 second.
-Agnikarma will be done in Bindu manner in the form of dots.
- Ghritkumari pulp will be applied immediately over the Agnikarma site after the procedure.
- After completing the procedure, bandaging will be done after applying Madhu & Ghrit.
- Total 5 sittings will be given at interval of 7 days (0,7, 14, 21,and 28th day).
)
|
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who have classical sign and symptoms of Gridhrasi.
2. Patients of age group between 35-70 years.
3. Willingness of patients for study.
|
|
| ExclusionCriteria |
| Details |
1.Uncontrolled Hypertension and Diabetes Mellitus.
2.HIV, Hepatitis B and HCV positive.
3.Known Malignancy of spine or other organs.
4.History of spine fracture (trauma).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome will be measured with the parameters
1.Subjective Parameter
-Ruka
-Stambha
-Aruchi
-Spandana
-Gaurava
2.Objective Parameter
-SLR Test |
Outcome will be measured with the parameters
1.Subjective Parameter
-Ruka
-Stambha
-Aruchi
-Spandana
-Gaurava
2.Objective Parameter
-SLR Test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SLR Test |
Assessment will be carried out on 14 days interval
for 28 days i.e. – on 0, 14th, 28th day
to find out the efficacy of Agnikarma and
Shiva guggulu in Gridhrasi (Sciatica). |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
25/09/2025 |
| 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="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
|
Gridhrasi is one of the eighty Vata-nanatmaj Vyadhi which is characterized by onset of Ruka, Toda, Stambha, Spandana initially in Sphika (buttock) and then radiating distally to posterior aspect of Kati (waist), Pristha (back), Uru (thigh), Janu (knee), Jangha (calf) up to Pada (foot). - It can be correlated with Sciatica due to its similarities in symptoms between them. - Sciatica is nerve pain and numbness from an injury or irritation to the sciatic nerve, which originates in buttock/ gluteal area. - Irritation of 4th and 5th lumbar and 1st sacral roots, which form the sciatic nerve, causes pain that extends mainly down the posterior and anterolateral aspects of leg and into the foot termed sciatica. Agnikarma - Acharya Sushruta has mentioned that Agnikarma Chikitsa is the best treatment amongst all other treatments as once the disease is cured with Agnikarma Chikitsa, it does not recur again. Aim - To compare the efficacy of Agnikarma and Shiva Guggulu(orally) in the management of Gridhrasi (Sciatica). Objective 1-To evaluate the effect of Agnikarma by Mrittika Shalaka in management of Gridhrasi (Sciatica) 2-To evaluate the effect of Shiva Guggulu in management of Gridhrasi (Sciatica). 3-To provide a cost effective and safe treatment for the patients of Gridhrasi (Sciatica). 4-To explore the literature regarding Agnikarma and Gridhrasi (Sciatica) in Ayurvedic and modern text |