| CTRI Number |
CTRI/2025/03/081553 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Gridhrasi Wsr to sciatica and effect of erandmuladi kwath in its management |
|
Scientific Title of Study
|
A clinical study of gridhrasi w.s.r to sciatica and evaluation of erandmuladi kwath in its management |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Boudh |
| Designation |
MD(Ay) SCHOLAR(kayachikitsa) |
| Affiliation |
Government Ayurvedic College and hospital |
| Address |
Department of Kayachikitsa Government Ayurvedic college and hospital Kadamkuan ,Patna
Patna
BIHAR
800003
India |
| Phone |
9144848823 |
| Fax |
|
| Email |
priyankaboudh45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay bahadur Singh |
| Designation |
HOD & Associate professor |
| Affiliation |
Government Ayurvedic College and hospital |
| Address |
Department of Kayachikitsa Government Ayurvedic college and hospital Kadamkuan Patna
Patna
BIHAR
800003
India |
| Phone |
7004642738 |
| Fax |
|
| Email |
vijay.md09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drvijay bahadur singh |
| Designation |
HOD & Associate professor |
| Affiliation |
Government ayurvedic college and hospital |
| Address |
Department of Kayachikitsa Government Ayurvedic college and hospital Kadamkuan Patna
Patna
BIHAR
800003
India |
| Phone |
7004642738 |
| Fax |
|
| Email |
vijay.md09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic college and hospital ,Kadamkuan ,Patna, Bihar-800003 |
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Boudh |
| Address |
Department of kayachikitsa, Government Ayurvedic college and Hospital,Kadamkuan,Patna, Bihar-800003 |
| Type of Sponsor |
Other [self] |
|
|
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 Priyanka Boudh |
Government Ayurvedic College and Hospital,Kadamkuan,Patna |
OPD NO 9,Department of Kayachikitsa, Government Ayurvedic college & Hospital Kadamkuan ,Patna
Patna
BIHAR |
09144848823
priyankaboudh45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee,Government Ayurvedic college and hospital,Kadamkuan,Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M95||Other acquired deformities of musculoskeletal system and connective tissue. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Erandmuladi kwath, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex between age group of 20-70 year will be included.The presence of Ruka, Toda, Stambha, and spandana in the sphik, kati, uru, janu, Jangha and pada.
Tenderness along the course of sciatica nerve.
SLR test in affected leg as objective measure for diagnosis and assessment will be taken. |
|
| ExclusionCriteria |
| Details |
Known cases of any major illness like DM, TM, AIDS and Malignancy.
Age below 20 and above 70 years.
Pregnancy
Anaemia (Hb less than 10 mg/dl)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in the patients will be assessed mainly on the basis of relief in the symptoms of disease . |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relief in symptoms like ruka ,toda,stambha,aruchi, gaurava etc |
45 days |
|
|
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
|
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 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 study is a single arm open trial to know the effectiveness of erandmuladi kwath in Gridhrasi w.s.r to sciatica , that will be conducted in Government Ayurvedic College and Hospital at Patna , Bihar in the department of kayachikitsa in a group of 30 patients . After 15 days of intervention , follow up will be done every 7 days for total duration of study i.e of 45 days . |