| CTRI Number |
CTRI/2023/08/056948 [Registered on: 25/08/2023] Trial Registered Prospectively |
| Last Modified On: |
09/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
Study on the etiological factors accountable for sciatica with special reference to vitamin B-12 deficiency |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY ON THE ETIOLOGICAL FACTORS ACCOUNTABLE FOR SCIATICA(GRIDHRASI) WITH SPECIAL REFERENCE TO VITAMIN B-12 DEFICIENCY |
| 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 NIDHI VISHWAKARMA |
| Designation |
PG SCHOLAR ROGA NIDAN EVUM VIKRITI VIGYAN |
| Affiliation |
PT. KHUSHILAL SHARMA GOVT. AYURVEDA COLLEGE & INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT,KOLAR NEHRU NAGAR BYPASS ROAD,BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9981014013 |
| Fax |
|
| Email |
nidhi.vishwakarma007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RITA SINGH |
| Designation |
READER OF ROG NIDAN EVUM VIKRITI VIGYAN DEPARTMENT |
| Affiliation |
PT. KHUSHILAL SHARMA GOVT. AYURVEDA COLLEGE & INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT,KOLAR NEHRU NAGAR BYPASS ROAD,BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8435990799 |
| Fax |
|
| Email |
vd.ritu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NIDHI VISHWAKARMA |
| Designation |
PG SCHOLAR ROGA NIDAN EVUM VIKRITI VIGYAN |
| Affiliation |
PT. KHUSHILAL SHARMA GOVT. AYURVEDA COLLEGE & INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT,KOLAR NEHRU NAGAR BYPASS ROAD,BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9981014013 |
| Fax |
|
| Email |
nidhi.vishwakarma007@gmail.com |
|
|
Source of Monetary or Material Support
|
| PT KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
|
|
Primary Sponsor
|
| Name |
PT KHUSHILAL SHARMA GOVT AUTO AYURVEDIC COLLEGE AND INSTITUTE |
| Address |
SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYPRADESH 462003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 NIDHI VISHWAKARMA |
PT KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLEGE AND INSTITUTE |
Department of Rog Nidan Evum Vikriti Vigyan Room no. 6 Ground floor SCIENCE HILLS BEHIND MANIT KOLAR NEHRUNAGAR BYPASS ROAD BHOPAL MADHYAPRADESH ,462003
Bhopal
MADHYA PRADESH |
9981014013
nidhi.vishwakarma007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE PT KLS AYURVEDA INSTITUTE BHOPAL |
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 |
|
|
|
Inclusion Criteria
|
| Age From |
31.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having clinical features of sciatica(Gridhrasi).
2.Patients willing to give the written consent for participation in the research study. |
|
| ExclusionCriteria |
| Details |
1.Patients not fulfilling the inclusion criteria.
2.Patients with other systemic disorder and serious illness.
3.Patients not willing to give the written consent for participation in the research. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that we will be able to find the role of vitamin B12 levels in the manifestation of Sciatica, especially in the vegans due to scarcity of its vegetarian sources |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will be helpful in clinical practice for the prevention & treatment of Sciatica |
12 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2023 |
| 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
|
It is expected that we will be able to find the role of vitamin B12 levels in the manifestation of sciatica(Gridhrasi) , especiall in the vegans due to scarcity of its vegetarian sources. It is further expected that this study will be helpful in the clinical practice for the prevention and treatment of this disease. |