| CTRI Number |
CTRI/2024/10/075318 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Agnikarma with Suvarnashalaka in the management of Gradhrasi (Sciatica) |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFECT OF AGNIKARMA WITH SUVARNSHALAKA IN THE MANAGEMENT OF GRIDHRASI WITH SPECIAL REFERENCE 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 |
DrShubham Vilas Patil |
| Designation |
MS Scholar -Shalya Tantra |
| Affiliation |
Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavilayadya |
| Address |
Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavidyalaya, Paithan Road, Kanchanwadi OPD no 16., Shalya Tantra Dpt Aurangabad MAHARASHTRA 431002 india
Aurangabad MAHARASHTRA 431002 India |
| Phone |
7770055886 |
| Fax |
|
| Email |
shubhampatil2554@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrSwapnil More |
| Designation |
Asso. Professor and Pg Guide |
| Affiliation |
Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavilayadya |
| Address |
Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavidyalaya, Paithan Road, Kanchanwadi OPD no 16., Shalya Tantra Dpt Aurangabad MAHARASHTRA 431002 india
Aurangabad MAHARASHTRA 431002 India |
| Phone |
8983357106 |
| Fax |
|
| Email |
dr.swapnilmore23@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrSwapnil More |
| Designation |
Asso. Professor and Pg Guide |
| Affiliation |
Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavilayadya |
| Address |
Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavidyalaya, Paithan Road, Kanchanwadi OPD no 16., Shalya Tantra Dpt Aurangabad MAHARASHTRA 431002 india
Aurangabad MAHARASHTRA 431002 India |
| Phone |
8983357106 |
| Fax |
|
| Email |
dr.swapnilmore23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavilayadya, Kanchanwadi, Chatrapati Sambhajinagar,431001 |
|
|
Primary Sponsor
|
| Name |
DrShubham Patil |
| Address |
Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavilayadya, Paithan Road, Kanchanwadi,Aurangabad MAHARASHTRA 431002 india |
| 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 |
| DrShubham Patil |
Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavidyalaya, Paithan Road, Kanchanwadi |
Chhatrapati shahu maharaj shikshan sanstha Ayurved Mahavidyalaya,opd no 16 Paithan Road, Kanchanwadi Aurangabad MAHARASHTRA |
7770055886
shubhampatil2554@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chhatrapati shahu maharaj shikshan sanstha institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G328||Other specified degenerative disorders of nervous system in diseases classified elsewhere. 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: Charak.Che 28/100, Procedure details: Latral position will be given.
Agnikarma will be done by Suvarna Shalaka at the site of maximum Sparshasathva on 1st, 7th day.
After Agnikarma immediately Ghrut will be applied as a cooling agent.)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient having age group of 30-70 yrs.
Irrespective of any gender, any socioeconomic site occupation.
Patient with sign and symptoms sciatica.
|
|
| ExclusionCriteria |
| Details |
Patient associated with known H/O any spinal surgery.
Malignancy, Lumbar Spine injury.
Osteoarthritis, Osteoporosis, Scoliosis.
Patient not eligible for Agni karma as per Ayurveda
|
|
|
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 |
| pain relief,increase leg range of movement |
1st,7th,14th dayu
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| easy to walk |
14th day |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/10/2024 |
| 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="1" 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
|
The prevalence of Gridhrasi is 1.2%, Untreated Gridhrasi can cause problems such as: erectile dysfunction (ED), menstrual problems, constipation, incontinence, urinary problems, leg swelling or edema, reproductive issues, and other problems. Gridhrasi is the commonest disease we observed as per the previous research there are various drugs that have been explored scientifically on Gridhrasi while reviewing the literature it was observed Agni karm with suvarnashalaka was not much studied till date hence hoping this studing may contribute further to public health. we have decided to use Agni karma with suvarnashalaka in the management of Gridhrasia The effect of the Kati Basti on different parameters gridhrasi. After a course of the Kati Basti, the analysis of the patients revealed that there is a statistically significant improvement seen in the parameters like sthambha, Ruk, toda, magnitude of pain, neurological deficit, functional ability, and functional disability. Agnikarma are simple, cheap, safe, and effective in the management of Gridhrasi but Agnikarma is more effective than Siravedha in relieving the main symptoms of the disease. Pain is chief cause of visiting a doctor in most patient. it is known asruja which is one of the symptoms of gradhrasi. It disturb physical and mental status of patient. |