| CTRI Number |
CTRI/2025/03/082958 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Clinico Study of Parijat Ghanvativati and Laghurajmruganak in the Management of Gridhrasi (Sciatica) |
|
Scientific Title of Study
|
Comparative Clinico Study of Parijat Ghanvati and Laghurajmruganak in the Management of Gridhrasi (Sciatica) – Randomized Controlled Trial. |
| 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 PRAVIN KHARADI |
| Designation |
HOD &Professor |
| Affiliation |
Shree Swaminarayan ayurvedic college, kalol |
| Address |
Department of kayachikitsa,
Shree Swaminarayan ayurvedic college, opp. Kalol GIDC, saij, Ahmedabad -Mehsana Highway, AT&PO, Ta, saij, kalol
Jamnagar
GUJARAT
382721
India |
| Phone |
9978136650 |
| Fax |
|
| Email |
pravinkharadi321@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RATHOD KHUSHBU RAJESHKUMAR |
| Designation |
MD scholer |
| Affiliation |
Shree Swaminarayan ayurvedic college, kalol |
| Address |
Department of kayachikitsa,
Shree Swaminarayan ayurvedic college, opp. Kalol GIDC, saij, Ahmedabad -Mehsana Highway, AT&PO, Ta, saij, kalol
Jamnagar
GUJARAT
382721
India |
| Phone |
7485956354 |
| Fax |
|
| Email |
rathodkhushbu.001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RATHOD KHUSHBU RAJESHKUMAR |
| Designation |
MD scholer |
| Affiliation |
Shree Swaminarayan ayurvedic college, kalol |
| Address |
Department of kayachikitsa,
Shree Swaminarayan ayurvedic college, opp. Kalol GIDC, saij, Ahmedabad -Mehsana Highway, AT&PO, Ta, saij, kalol
Jamnagar
GUJARAT
382721
India |
| Phone |
7485956354 |
| Fax |
|
| Email |
rathodkhushbu.001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Swaminarayan ayurvedic college, Ahmedabad-Mehsana Highway, AT&PO , saij, Ta. Kalol, Dist-gandhinagar-382721 |
|
|
Primary Sponsor
|
| Name |
Shree Swaminarayan ayurvedic college kalol |
| Address |
Shree Swaminarayan ayurvedic college, Ahmedabad-Mehsana Highway, AT&PO. |
| 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 |
| RATHOD KHUSHBU RAJESHKUMAR |
Preamswarup Swami ayurvedic multi-speciality Hospital, kalol |
OPD 004, Department of kayachikitsa premswarup Swami ayurvedic multi-speciality Hospital,Ahmedabad-Mehsana Highway AT&po saij Ta. Kalol Dist gandhinagar, gujrat-382721
Gandhinagar
GUJARAT |
7485956354
rathodkhushbu.001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-SHREE SWAMINARAYAN AYURVEDA COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G570||Lesion of sciatic nerve. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Parijat ghanvati , Reference: Charkradatta , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -usnodak ), Additional Information: -nil | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Laghurajmrugank , Reference: Bhruhatnighantu ratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -usnodak), Additional Information: NIL |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patient fulfilling the diagnosis criteria
2.patient between the ages of 18-60 years .
3.both types of gridhrashi roga. |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from pathological condition like bone tumor, spine
tuberculosis etc.
2.Patients of diabetes mellitus and with other chronic disorders which may affect
the outcome of the study.
3.Pregnant/ lactating woman |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of the parijat ghanvati.
Evaluation of the laghurajmruganak.
Comparative study in the management of gridhrasi (sciatica) .
|
Baseline ,Day 30,Day 45
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Understanding the pathophysiology of gridhrasi from both ayurvedic and morden aspects.
2. Evaluate subjective changes in symptoms. |
Baseline , Day 30 ,Day 45 |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="0"
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
|
Gridhrasi or sciatica, is
recognized as a disorder in Ayurvedic texts, characterized by radiating pain ,
stiffness and pain an imbalance of vata or vata-kapha dosha. Despite Ayurveda’s
traditional use in treating sciatica. scientific validation of its efficacy is
lacking,in particularly concerning specific comparative treatment like Parijat
ghanvati and laghurajmrugank . This study seeks to bridge this gap by exploring
the scientific basis of Ayurvedic interventions for sciatica.The study involves 40
individuals diagnosed with sciatica. Who will receive Parijat ghanvati and
laghurajmrugank for duration of 30 days.this study will monitor changes in
their symptoms throughout the treatment period.In modern medication
management involves NSAIDS ,corticosteroids, analgesics for sciatica Which can have adverse
effects and dependency issues. In ayurveda this study aim to provides
effectiveness and promotes their wider adaptation.The research will focus
on comparative effectivness on Parijat ghanvati and laghurajmrugank. By
clarifying this points, the study aims to enhance understanding and acceptance
of Ayurvedic practices in sciatica , to improves healthcare options.
|