| CTRI Number |
CTRI/2025/05/087834 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study on efficacy of Erandadi kwatha and symhasyadi kwatha in treatment of Gridhrasi (sciatica) |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Erandadi kwatha and symhasyadi kwatha 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 |
Dr Vaishnavi kiranrao Sowale |
| Designation |
MD scholar |
| Affiliation |
Department of kayachikitsa Shree Saptashrungi Ayurved Mahavidyala And Hospital Nashik |
| Address |
OPD NO.2 Department of Kayachikitsa, Shree Saptashrungi Ayurved Mahavidyala and Hospital,Kamal Nagar, Hirawadi, Panchawati,Nashik Maharashtra422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
8999349832 |
| Fax |
|
| Email |
Vaishnavi.sowale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Somdatta Bhaskarrao Kulkarni |
| Designation |
HOD |
| Affiliation |
Department of kayachikitsa, Shree Saptashrungi Ayurved Mahavidyala, and Hospital Nashik |
| Address |
OPD No. 2 Department of kayachikitsa, Shree Saptashrungi Ayurved Mahavidyala and Hospital, Kamal Nagar, Hirawadi Panchawati Nashik 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
8999349832 |
| Fax |
|
| Email |
Somdattak85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVaishnavi kiranrao Sowale |
| Designation |
MD scholar |
| Affiliation |
Department of kayachikitsa Shree Saptashrungi Ayurved Mahavidyala and Hospital Nashik |
| Address |
OPD NO.2 Department of kayachikitsa, Shree Saptashrungi Ayurved Mahavidyala and Hospital Kamal Nagar Hirawadi Panchawati Nashik Maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
8999349832 |
| Fax |
|
| Email |
vaishnavi.sowale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of kayachikitsa Shree Saptashrungi Ayurved Mahavidyala and Hospital Kamal Nagar Hirawadi Panchawati Nashik Maharashtra 422003 |
|
|
Primary Sponsor
|
| Name |
Shree saptashrungi Ayurved Mahavidyala and Hospital Kamal Nagar Hirawadi Panchawati Nashik |
| Address |
Department of kayachikitsa Shree Saptashrungi Ayurved Mahavidyala and Hospital Kamal Nagar Hirawadi Panchawati Nashik Maharashtra 422003 |
| 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 Vaishnavi kiranrao Sowale |
Shree saptashrungi Ayurved Mahavidyala and Hospital |
Department of kayachikitsa Shree Saptashrungi Ayurved Mahavidyala and Hospital Kamal Nagar Hirawadi Panchawati Nashik Maharashtra 422003
Nashik
MAHARASHTRA |
8999349832
Vaishnavi.sowale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree saptashrungi Ayurved Mahavidyala and Hospital Nashik |
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 | Drug | Classical | | (1) Medicine Name: Erandadi kwatha , Reference: Bhaishajya ratnavali 26 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -saindhav ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Symhasyadi kwatha , Reference: Bhaishajya ratnavali 26 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Erand sneha), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient having positive straight leg raise test. |
|
| ExclusionCriteria |
| Details |
1) patient having lower limb paraplegia or hemiplegia.
2) pregnant and lactating women.
3) History of any vertibral/surgical/diagnostic intervention with reference to affected joints
4) gross disability in performing daily normal routine that is bedridden patient or confined to wheelchair
5) patient with known comorbidities such as gouty arthritis, rheumatoid arthritis or psoriatic arthritis, tubercular arthritis
6) patient with evidence of malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of gridhrasi |
At base line 15th and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in sign & symptoms of Gridhrasi with improvement in SLR test Grading |
30th 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/06/2025 |
| 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="6"
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
|
Primary objectives - 1) To study the effect of Erandadi kwatha in Gridhrasi 2) To study the effect of Simhasyadi Kwatha in Gridhrasi. 3) To compare the effect of Erandadi kwatha with Simhasyadi Kwatha in management of Gridhrasi with special reference to sciatica Study - Comparative clinical study. Group A - Erandadi kwatha Group B - Simhasyadi Kwatha
Duration of treatment - 30 Days Initial assessment on 1st day Follow up on 15th and 30th day
Data Analysis - Data will be analysed using appropriate statistical methods to compare the effectiveness of intervention on primary and secondary outcomes.
Ethical considerations - The study will be conducted in accordance with Ethical Guidelines and with infirmed consent from participants. Conclusion - conclusion will be drawn on the basis of statistical analysis of data. |