| CTRI Number |
CTRI/2024/12/077983 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Viddha and Agni karma in the treatment of Sciatica. |
|
Scientific Title of Study
|
A comparative clinical evaluation of viddha karma and agni karma in 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 |
Dr.Sandhya patel |
| Designation |
M.S. SCHOLAR |
| Affiliation |
Government ayurved college and hospital |
| Address |
Department of Shalya Tantra, Government Ayurved College and Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8004773027 |
| Fax |
|
| Email |
sandhyapatel76466@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Yadav |
| Designation |
PROFESSOR |
| Affiliation |
Government Ayurved College and Hospital |
| Address |
OPD NO.25, Department of Shalya Tantra, Government Ayurved College and Hospital, Varanasi
Department of Shalya Tantra, Government Ayurved College and Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
09451965767 |
| Fax |
|
| Email |
yadavsuman2073@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Mishra |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurved College and Hospital |
| Address |
OPD NO.11, Department of Kaya Chikitsa, Government Ayurved College and Hospital, Varanasi
DEPARTMENT OF SHALYA TANTRA, GOVERNMENT AYURVEDA COLLEGE AND HOSPITAL, VARANASI
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9721217773 |
| Fax |
|
| Email |
drshwetamishraaiia@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD no 25, Department of shalya tantra Government Ayurved College and Hospital, Varanasi UP Pincode 221002 |
| opd no 8 and 11 ,Department of kaya chikitsa Government Ayurved college and hospita, varanasi UP Pincode 221002 |
|
|
Primary Sponsor
|
| Name |
Government pg ayurveda college and hospital varanasi |
| Address |
OPD No.25, Department of shalya tantra OPD No.8,11 Department of kaya chikitsa Government Ayurved College and Hospital, Varanasi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sandhya Patel |
Government ayurved college and hospital |
OPD NO 25 Department of Shalya Tantra, Government Ayurved College and Hospital, Varanasi
Varanasi
UTTAR PRADESH |
08004773027
sandhyapatel76466@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government ayurved college and hospital varanasi UP Mahayogi guru Gorakhnath Ayush university Gorakhpur UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | viddhakarma | (Procedure Reference: sushruta sharira - 8/17, Procedure details: ï‚·Using Vrihimukha Shastra (resemblance with insulin syringe no 26) on 4angula above & below knee joint on lateral aspect,ï‚·Such 5-6 vedhana has done at once / 5 min )
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Ch.chi.28/101, Procedure details: 5-15 Bindu (Dahana Vishesha) Samyaka Dagdha are produced by Panchadhatu Shalaka on achilles tendon region as well as maximum tender points. Weekly for 28 days.)
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients are selected presenting symptoms of Sciatica.
2.Patients above 16 years and less than 70 years age.
3.Clinical symptoms with or without radiological changes with less than one year.
4.Patients with classical sign and symptoms of Gridhrasi and Sciatica as described in Ayurveda text and modern literature includes-
Ruka (Pain)
Toda (Pricking sensation)
Stambha (Feeling of tightness and rigidity thoughout the leg)
Spandana (Throbbing/Pulsating pain)
Sakthikshepa Nigraha (Retricted movement of the affected limb)
Tandra (Drowsiness)
Aruchi (Anorexia)
Tenderness
|
|
| ExclusionCriteria |
| Details |
1.Patients less than 16 years and more than 70 years of age.
2.Patients suffering from post-surgical conditions of lumber spine.
3.Frature related to spine.
4.Uncontrolled Diabetes mellitus,Hypertension,Tuberculosis of spine and hip joint,Malignancy of spine or other organs.
5.Cardiac disease(Ischemic heart disease,Coronary artery disease,myocardial infarction etc).
6.Patient with HBsAg,
7.HIV I,II.
8.HCV
9.Patients with infective ,neoplastic condition of spine.
10.Pregnant females and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain relief in gridhrasi |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| stiffness relief, swelling |
2-3 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
21/12/2024 |
| 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="2"
Months="0"
Days="15" |
|
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
|
INTERVENTIONAL STUDY
PATIENT IS SUFFERING FROM PAIN AND STIFFNESS IN LOWER LIMBS WILL BE SELECTED FROM OPD AND IPD OF GOVERNMENT PG AYURVED COLLEGE AND HOSPITAL ,VARANASI
TOTAL PATIENT =60 DIVIDED INTO TWO GROUPS EACH HAVING 30 PATIENTS
TREATMENT PLAN =
VIDDHAKARMA PROCEDURE : 1. Site where Viddhakarma has to be carried out, is cleaned with spirit. 2.Viddha karama procedure is done in supine position of the patient. 3. Using Vrihimukha Shastra (resemblance with insulin syringe no 26) on 4angula above and below knee joint on lateral aspect. 4. Pierced up to the depth of Yav praman (4-6mm) (dr.R.B.Gogate sir ). 5. The needle is taken off the body soon after pricked. 6. Such 5-6 vedhana has done at once. 7.The area as cleaned again with the cotton piece. No dressing is applied over the local area that had been pricked and applied some Til Tail(Sesame oil).
AGNIKARMA PROCEDURE:1. The site will be will be washed out with Triphala Kwatha. 2.5-15 Bindu (Dahana Vishesha) Samyaka Dagdha are produced by Panchadhatu Shalaka on achilles tendon region as well as where pain is more prominent. 3.After Agnikarma the small piece of Kumari Patra/Ghrita held with swab holding forceps is applied on Samyaka Dagdha Vrana to get relief from burning sensation instantly.
FOLLOW UP = 28 DAYS
|