| CTRI Number |
CTRI/2025/06/088107 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
01/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
causes of Gridhrasi and effect of abhadi churna in treatment of sciatica |
|
Scientific Title of Study
|
Etiopathogenesis of Gridhrasi with special reference to Sciatica and its Upashayatamaka Parikshana with Abhadi Churna |
| 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 Indrasan Kumar Prajapati |
| Designation |
P G Scholar |
| Affiliation |
S. G. M. P. G. Ayurvedic College and Hospital |
| Address |
Department of Rog Nidan Saheri Nandgunj
Ghazipur
UTTAR PRADESH
233302
India |
| Phone |
8805142214 |
| Fax |
|
| Email |
prayagayurvedagkp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rjiv Kumar Rai |
| Designation |
Professor |
| Affiliation |
S G M P G Ayurvedic College and Hospital |
| Address |
HOD Department of Rog Nidan Ground Floor Saheri Nandgunj
Ghazipur
UTTAR PRADESH
233302
India |
| Phone |
8805142214 |
| Fax |
|
| Email |
drrajivrai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indrasan Kumar Prajapati |
| Designation |
P G Scholar |
| Affiliation |
S G M P G AYURVEDIC COLLEGE AND HOSPITAL |
| Address |
Department of Rog Nidan Saheri Nandgunj
Ghazipur
UTTAR PRADESH
233302
India |
| Phone |
8805142214 |
| Fax |
|
| Email |
prayagayurvedagkp@gmail.com |
|
|
Source of Monetary or Material Support
|
| S G M P G Ayurvedic College and Hospital Saheri Ghazipur Uttar Pradesh 233302 |
|
|
Primary Sponsor
|
| Name |
Dr Indrasan Kumar Prajapati |
| Address |
S G M P G Ayurvedic College and Hospital Saheri Ghazipur Uttar Pradesh 233302
|
| 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 Indrasan Kumar Prajapati |
S G M P G Ayurvedic College and Hospital |
OPD Department of Rog Nidan Ground floor Saheri Nandgunj
Ghazipur
UTTAR PRADESH |
8805142214
prayagayurvedagkp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC S.G.M.P.G. Ayurvedic College Saheri Ghazipur Uttar Pradesh |
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: GRUDH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Abhadi Churna, Reference: Yogaratnakar vatvyadhi chapter 10 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Age group 20 – 60 years of both sex.
2 Patients having lakshana’s of Gridhrasi as per Ayurvedic texts.
3 Patients having sign and symptoms of Sciatica as per modern medicine.
4 Patients having positive SLR test on examination.
5 Patients diagnosed on the basis of radiological findings.
6 Newly diagnosed cases of Sciatica.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Criteria for diagnosis were done on the basis of sign and symptoms available in the Ayurvedic and Modern texts as well as with the help of following parameters.
Presence of Ruka, Toda, Stambha and Spandana in the Sphika, Kati, Uru, Janu, Jangha and Pada.
S.L.R. test in affected leg as objective measure for diagnosis as well as for improvement of the treatment.
|
4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
For Differential Diagnosis
CRP (Qualitative Method)
ASO Titre
RA Factor
Serum Uric Acid
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/06/2025 |
| 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="2"
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
|
The
whole research work will be summarized and conclusion will be made on the basis
of the observation which will be done on the subjective and objective
parameters. Result will be analyzed statically & discussed accordingly |