| CTRI Number |
CTRI/2024/07/070110 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Agnikarma in the pain management of Gridhrasi (Sciatica) |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Trial to evaluate the efficacy of Agnikarma in the pain management of Gridhrasi with special reference to Sciatica according to Sushruta Samhita and Harita Samhita. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DR BOGANATHAM VENKATA SUMANJALI |
| Designation |
PG Scholar |
| Affiliation |
BVVS Ayurved Medical College and Hospital Bagalkot |
| Address |
Department of PG Studies in Shalya Tantra
BVVS Ayurved Medical College and Hospital BVVS Old Campus Bagalkot
Bagalkot KARNATAKA 587101 India |
| Phone |
9035192082 |
| Fax |
|
| Email |
sumanjalibala@gmail.com |
|
Details of Contact Person Scientific Query
Modification(s)
|
| Name |
Dr Pallavi A Hegde |
| Designation |
Professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital Bagalkot |
| Address |
Department of PG Studies in Shalya Tantra
BVVS Ayurved Medical College and Hospital BVVS Old Campus Bagalkot
Bagalkot KARNATAKA 587101 India |
| Phone |
9448636321 |
| Fax |
|
| Email |
drpallaviah@rediffmail.com |
|
Details of Contact Person Public Query
Modification(s)
|
| Name |
Dr Pallavi A Hegde |
| Designation |
Professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital Bagalkot |
| Address |
Department of PG Studies in Shalya Tantra
BVVS Ayurved Medical College and Hospital BVVS Old Campus Bagalkot
Bagalkot KARNATAKA 587101 India |
| Phone |
9448636321 |
| Fax |
|
| Email |
drpallaviah@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| BVVS Ayurved Medical College and Hospital, Bagalkot, KArnataka - 587101 |
|
Primary Sponsor
Modification(s)
|
| Name |
BVVS Ayurved Medical College and Hospital |
| Address |
BVVS Ayurved Medical College and Hospital BVVS campus
old bus stand road Bagalkot Karnataka 587101 |
| 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 B V Sumanjali |
BVVS Ayurved Medical College and Hospital |
Shalyatantra OPD
Room No: 03 BVVS
Ayurved Medical
College and Hospital
Bagalkot
KARNATAKA Bagalkot KARNATAKA |
9035192082
sumanjalibala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC BVVS AYURVED MEDICAL COLLEGE AND HOSPITAL,BAGALKOT,KARNATAK |
Approved |
|
|
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 | - | agnikarma, अगà¥à¤¨à¤¿à¤•रà¥à¤® | (Procedure Reference: Haritha Samhitha, Procedure details: Bindu rupi Agnikarma with panchaloha shalaka will be performed on 4 angula above gulpha sandhi till samyak dagdha laxanas are seen. Once in a week for 3 weeks.)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•रà¥à¤® | (Procedure Reference: Sushruta samhita, Procedure details: Bindu rupi Agnikarma will be performed with panchaloha shalaka on atiugra ruja sthana till samyak dagdha lakhanas are seen. Once in a week for 3 weeks.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
•Presence of Ruk, Toda, Stambha in the Sphik, Kati, Uru, Janu, Jangha, Pada.
•Patients with controlled Diabetes Mellitus and Hypertension. |
|
| ExclusionCriteria |
| Details |
•Patient with Traumatic paraplegia, Paraplegia, Hemiplegia, other Tumors of spine, Bowel & Bladder incontinence, TB of spine, Congenital anomalies.
•Patient with history of Fractures and traumatic injuries of hip joint.
• Pregnant women and Lactating women.
• Patients who are Anarha for Agnikarma.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain |
21days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in stiffness |
21 days |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
15/07/2024 |
| 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="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 a condition in which Vata getting aggravated due to Nidana Sevana, invades the Kandaras of the Parshni (ankle) and Pratyanguli (toes), and produces Kshepa (pain and inability to extend) in the Sakthi (thighs) . Acharya Harita explained about Gridhrasi, where Vedana (pain) is the main feature in Kati, Uru, Jangha and Janu Pradesha and according to Acharya Charaka it is a disorder in which Ruk (pain), Toda (pricking pain) and Stambha (stiffness) are the main features where pain starts from Sphik Pradesha (lower back) and radiates downwards to Kati, Prusta, Uru, Janu, Jangha and Pada. In Sciatica, symptoms like pain and stiffness which starts from the lower back region and radiates down to one or both lower limbs. The pain is distributed along the sciatic nerve. Thus the disease Gridhrasi can be correlated to Sciatica. In the contemporary science, pain is managed by the administration of muscle relaxants, NSAIDs, corticosteroids etc. Long term usage of these medicines may cause mild to serious systemic illness. Prevalence ranging from 2–5%, depending on the population. Lifetime incidence is reported to be between 10% to 40% and an annual incidence of 1 to 5% in India. It rarely occurs before age 20 unless secondary to trauma. There is no association with body weight or height except in 50 years to 60 years age group. In Ayurveda, Gridhrasi is treated with Bheshaja, Siravyadhana, Bastikarma and Agnikarma. Acharya Sushruta explained the importance of Agnikarma which can be performed at Atiugraruja Sthana of Twacha, Mamsa, Sira, Snayu, Sandhi and Asthi Vikaras and according to Acharya Harita, Gridhrasi is a condition which is managed by Agnikarma at Gulpha Chaturangule. Thus the study is undertaken to evaluate the pain management efficacy of Agnikarma with Panchaloha Shalaka in Gridhrasi with special reference to Sciatica on two different sites explained by Acharya Sushruta and Acharya Harita. |