| CTRI Number |
CTRI/2025/03/081695 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two treatment protocols,Viddhaagnikarma and Agnikarma in patients with Gridhrasi(Sciatica). |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Viddhaagnikarma And Agnikarma In The Pain Management Of Gridhrasi Vis A Vis 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 Apoorva V Mahale |
| Designation |
Post Graduate Scholar |
| Affiliation |
Ayurveda Mahavidyala And Hospital Hubli |
| Address |
Department of Shalya Tantra
Ayurveda Mahavidyalaya and Hospital
Heggeri Extension
Hubballi Karnataka 580024
Anugraha Plot 123 Vinayak Colony Vidyanagar Hubli 580031
Dharwad
KARNATAKA
580024
India |
| Phone |
9448375855 |
| Fax |
|
| Email |
drapoorva4499@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhakar H Taseen |
| Designation |
Professor |
| Affiliation |
Ayurveda Mahavidyala And Hospital Hubli |
| Address |
Department of Shalya Tantra
Ayurveda Mahavidyalaya and Hospital
Heggeri Extension
Hubballi Karnataka 580024
Department of Shalya Tantra
Ayurveda Mahavidyalaya and Hospital
Heggeri Extension
Hubballi Karnataka 580024
Dharwad
KARNATAKA
580024
India |
| Phone |
9844765647 |
| Fax |
|
| Email |
tasinph@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apoorva V Mahale |
| Designation |
Post Graduate Scholar |
| Affiliation |
Ayurveda Mahavidyala And Hospital Hubli |
| Address |
Department of Shalya Tantra
Ayurveda Mahavidyalaya and Hospital
Heggeri Extension
Hubballi Karnataka 580024
Anugraha Plot 123 Vinayak Colony Vidyanagar Hubli 580031
KARNATAKA
580024
India |
| Phone |
9448375855 |
| Fax |
|
| Email |
drapoorva4499@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurveda Mahavidyalaya Hubli
Department of Shalya Tantra
Heggeri extension
Hubli |
|
|
Primary Sponsor
|
| Name |
Dr Apoorva V Mahale |
| Address |
Ayurveda Mahavidyalaya and Hospital Hubli
Heggeri Extension Hubli 580024 |
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ayurveda Mahavidyalaya Hubli |
Ayurveda Mahavidyalaya and Hospital Hubli
Heggeri Extension Hubli 580024 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Apoorva V Mahale |
Ayurveda Mahavidyala and Hospital Hubli |
Department of Shalya Tantra
Ayurveda Mahavidyalaya and Hospital Hubli
Heggeri extension Hubli
Dharwad
KARNATAKA |
9448375855
drapoorva4499@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Ayurveda Mahavidyalaya Hubli |
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 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushruta Samhita , Procedure details: Agnikarma procedure for 4 sittings with a gap of 1 week each sitting for 28 days )
(1) Medicine Name: Rasna Saptaka Kashaya , Reference: Bhavaprakasha, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Duration: 28 Days | | 2 | Intervention Arm | Procedure | - | Viddhaagnikarma | (Procedure Reference: No direct reference, Procedure details: Viddhaagnikarma 4 sittings with a gap of 1 week for each sitting for 28 days)
(1) Medicine Name: Rasna Saptaka Kashaya, Reference: Bhavaprakasha, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects presenting with pratyatma lakshana of Gridhrasi ruja
Subjects with SLR test positive
Subject fit for Viddhaagnikarma and Agnikarma |
|
| ExclusionCriteria |
| Details |
Subject with traumatic neoplastic infective and congenital condition of spine
Subjects with retro positive RA positive and malignancies
Subjects with uncontrolled diabetes mellitus and Hypertension
Subjects taking any other medicine for the same disease like opioids NSAIDs
Subjects with anemia and pregnant women |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain management in Gridhrasi Vis A Vis Sciatica,
assessed and graded based on VAS scale |
28 days, assessed at 7th,14th,21st and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Viddhaagnikarma in Pain management of Gridhrasi Vis A Vis Sciatica |
28 days assessed at 7th,14th,21st & 28th day |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| 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 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
|
Primary protocol- To evaluate and compare the efficacy of Viddhaagnikarma and Agnikarma in the pain management of Gridhrasi. Agnikarma is particularly effective for immediate pain relief, achieving long-term benefits without recurrence. Viddhakarma along with Agnikarma is a unique treatment of Ayurveda for instant relief of pain and disease management. Viddhakarma is also known as Vyadhana; which is one among the ashta vidha shastra karmas.12 Acharya Vagbhata explains Suchi as one among the Dahanopakaranas.13 In Viddhagnikarma multiple Suchis are used to pierce the most affected tender areas excluding the Marma points where considerable amount of heat is transmitted through the Suchi by conductive method. Piercing the most tender points leads to mechanical stimulation, releases the vitiated Sthanika Vata dosha and removes margavarodha, which leads to pacification of Vata dosha; there by subsiding pain. Hence, it is useful in immediate pain relief. There is no direct reference available regarding Viddhaagnikarma, but by looking at previous works, articles and clinical practice, better results were found in various vatavyadhis. Therefore, Viddhagnikarma is selected for the present study as a trial group. This study mainly focuses on pain management in Gridhrasi by comparing the efficacy of Viddhagnikarma and Agnikarma along with Rasnasaptaka Kashaya as an adjunct, under the title: "A Comparative Clinical Study to Evaluate the Efficacy of Viddhaagnikarma and Agnikarma in the Pain Management of Gridhrasi Vis-À-Vis Sciatica." Hypothesis- Ho- There is no significant effect of Viddhagnikarma and Agnikarma in Gridhrasi H1- There is significant effect of Viddhaagnikarma in Gridhrasi
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