| CTRI Number |
CTRI/2024/06/069457 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
21/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Management of low back pain which is radiating to lower limbs with sudation therapy |
|
Scientific Title of Study
|
Comparative Clinical Study to Evaluate the Efficacy of Ishtika choorna and Kola Kulatthadi Choorna pinda sweda in Vata Kaphaja Gridrasi |
| 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 Pavan H R |
| Designation |
Pg scholar |
| Affiliation |
Sri Dharmasthala manjunatheshwara college of ayurveda and hospital |
| Address |
Department of Panchakarma Sri Dharmasthala manjunatheshwara college of ayurveda and hospital B M road tanniruhalla hassan
Hassan
KARNATAKA
573201
India |
| Phone |
7892460105 |
| Fax |
|
| Email |
hrpavan32@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lohith B A |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala manjunatheshwara college of ayurveda and hospital |
| Address |
Department of Panchakarma Sri Dharmasthala manjunatheshwara college of ayurveda and hospital B M road tanniruhalla hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9886749168 |
| Fax |
|
| Email |
drlohithpk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lohith B A |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala manjunatheshwara college of ayurveda and hospital |
| Address |
Department of Panchakarma Sri Dharmasthala manjunatheshwara college of ayurveda and hospital B M road tanniruhalla hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9886749168 |
| Fax |
|
| Email |
drlohithpk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala manjunatheshwara college of ayurveda and hospital B M road Tanniruhalla hassan karnataka -573201 |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala manjunatheshwara college of ayurveda and hospital |
| Address |
Sri Dharmasthala manjunatheshwara college of ayurveda and hospital B M road tanniruhalla hassan Karnataka-573201 |
| 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 Pavan H R |
Sri Dharmasthala manjunatheshwara college of ayurveda and hospital |
IPD and OPD under all the departments of Sri Dharmasthala manjunatheshwara college of ayurveda and hospital B M road tanniruhalla hassan Karnataka-573201
Hassan
KARNATAKA |
7892460105
hrpavan32@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
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 | - | sa~gkarasvedaH, संकरसà¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: vangasena samhitha, Procedure details: ishtika choorna pinda sweda will be carried out for 15 minutes)
(1) Medicine Name: ishtika choorna, Reference: vangasena samhitha, Route: Topical, Dosage Form: Churna/ Powder, Dose: 250(g), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | sa~gkarasvedaH, संकरसà¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: charaka samhitha, Procedure details: kolakulatthadi choorna pinda sweda will be carried out for 15 minutes )
(1) Medicine Name: kolakulatthadi choorna, Reference: charaka samhitha, Route: Topical, Dosage Form: Churna/ Powder, Dose: 250(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants fulfilling the diagnostic criteria 20-60 years of either gender.
Participants who are ready to sign the informed consent
Participants who are diagnosed with gridhrasi affecting one lower limb.
Participants with positive Straight Leg Raising (SLR) test
|
|
| ExclusionCriteria |
| Details |
Pregnancy
Diagnosed cases of systemic disorders like chronic heart disease, chronic renal failure and chronic liver disease which may interfere with the course of the treatment.
Diagnosed cases of HIV, HBsAg, Carcinoma and Tuberculosis.
Fractures of pelvis and femur
Any infective conditions of spine like Pott’s spine
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessment will be based on improvement in signs and symptoms of Gridrasi like pain,stiffness,anorexia,heaviness and objective parameters like SLR, Range of movements |
untill samyak sweda lakshanas obtained or 7 days whichever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement in quality of life |
7 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/07/2024 |
| 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="0"
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
|
in general an estimated 5% - 10% of patients with low back pain experiences sciatica, while the life time prevalence with low back pain ranges from 49-70%. The annual prevalence of disc related sciatica in general population is 2.2% Rooksha swedana is recommended in vata kaphaja vyadhis and it can be administered in various forms,including pinda sweda There are different forms of pinda sweda in practice such as vaaluka sweda ,chincha lavana pinda sweda ishtika possesses rooksha properties making it as a suitable option for rooksha sweda.Ishtika choorna pinda being less commonly practiced, and cost effective is being evaluated for its efficacy in treating vata kaphaja gridhrasi |