CTRI Number |
CTRI/2023/07/055400 [Registered on: 20/07/2023] Trial Registered Prospectively |
Last Modified On: |
22/07/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Effect of Marma chikitsa and Agnikarma along with Gridhrasinashak kwath on sciatica |
Scientific Title of Study
|
A comparative clinical study on Marma chikitsa and Agnikarma along with Gridhrasinashak kwath in the management of Gridhrasi W.S.R. 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 Kirti Garasiya |
Designation |
PG Scholar |
Affiliation |
Madan Mohan Malaviya Government Ayurved college Udaipur |
Address |
PG Scholar
Shalya tantra Department
Madan Mohan Malaviya Government Ayurved College Udaipur
PIN 313001
Udaipur RAJASTHAN 313001 India |
Phone |
9928718686 |
Fax |
|
Email |
kirtigarasiya09@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mahesh Dixit |
Designation |
Professor & HOD |
Affiliation |
Madan Mohan Malaviya Government Ayurved College Udaipur |
Address |
Professor & HOD
Shalya tantra Department
Madan Mohan Malaviya Government Ayurved College Udaipur
PIN 313001
Udaipur RAJASTHAN 313001 India |
Phone |
9414245459 |
Fax |
|
Email |
prof.maheshdixit@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mahesh Dixit |
Designation |
Professor & HOD |
Affiliation |
Madan Mohan Malaviya Government Ayurved College Udaipur |
Address |
Professor & HOD
Shalya tantra Department
Madan Mohan Malaviya Government Ayurved College Udaipur
PIN 313001
Udaipur RAJASTHAN 313001 India |
Phone |
9414245459 |
Fax |
|
Email |
prof.maheshdixit@gmail.com |
|
Source of Monetary or Material Support
|
Madan Mohan Malaviya Government Ayurved college Udaipur |
|
Primary Sponsor
|
Name |
Madan Mohan Malaviya Government Ayurved college Udaipur |
Address |
Madan Mohan Malaviya Government Ayurved college Udaipur
PIN 313001 |
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 |
Dr Kirti Garasiya |
Madan Mohan Malaviya Government Ayurved College Udaipur |
OPD No 1
PG Department of shalya tantra
Associated group of hospitals
Madan Mohan Malaviya Government Ayurved college Udaipur
PIN 313001 Udaipur RAJASTHAN |
9928718686
kirtigarasiya09@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee,M.M.M. Govt.Ayurved College,Udaipur |
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 | - | marmacikitsA, मरà¥à¤®à¤šà¤¿à¤•ितà¥à¤¸à¤¾ | (Procedure Reference: Sushrutha samhitha, Procedure details: Pressure will be applied through hands on marma points for the duration of 20 times per minute) (1) Medicine Name: Gridhrasinashak kwath, Reference: Sharanghdhara samhitha, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 1 Months | 2 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•रà¥à¤® | (Procedure Reference: Sushrutha samhitha, Procedure details: Agnikarma will be done using shalaka on 4 finger distance from gulfa in the interval of 1 week for the duration of 1 month) (1) Medicine Name: Gridhrasinashak kwath, Reference: Sharngadhara samhitha, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 1 Months |
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1)Patients suffering from signs and symptoms of gridhrasi
2)Patient with SLR positive
3)Diagnosed cases of PID |
|
ExclusionCriteria |
Details |
1)Age below 20 yrs and above 60 yrs
2)pregnant womens
3)Patients suffering from DM,tuberculosis of spine and hip joint
4) Malignancy of spine |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1)Improvement in signs & symptoms of gridhrasi
2)Improvement in SLR & walking distance,stambha,ruka,toda and suptata |
1 month |
|
Secondary Outcome
|
Outcome |
TimePoints |
Improvement in SLR & walking distance |
2 weeks |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
|
30/07/2023 |
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="0" 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
|
This is a mutiple arm study to evaluate the efficacy of marma chikitsa and agnikarma along with gridhrasinashak kwath in the management of gridhrasi.In this trial grp A , 15 patients will be administered with marma chikitsa and gridhrasinashak kwath,40 ml,bd for the duration of 1 month.And grp B,15 patients will be administered with agnikarma and gridhrasinashak kwath,40ml,bd for the duration of 1 month. |