| CTRI Number |
CTRI/2024/11/076729 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational study |
| Study Design |
Other |
|
Public Title of Study
|
To Study the incidence of sciatica in individuals of different temperaments |
|
Scientific Title of Study
|
To study the incidence of Irq ul nasa (sciatica) in individuals of different temperaments |
| 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 Sana Fatima |
| Designation |
PG Scholar |
| Affiliation |
Government nizamia tibbi college and general hospital |
| Address |
PG Department Of Kulliyat e Tibb,Government Nizamia Tibbi College And General Hospital, Charminar, Hyderabad.
Hyderabad
TELANGANA
500002
India |
| Phone |
8074048665 |
| Fax |
|
| Email |
Sanafatimaaaa99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Yousufuddin |
| Designation |
HOD and PG Professor |
| Affiliation |
Government Nizamia Tibbi College And General Hospital |
| Address |
PG Department Of Kulliyat e Tibb,Government Nizamia Tibbi College And General Hospital, Charminar, Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9912904786 |
| Fax |
|
| Email |
Yousufmohd96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohd Yousufuddin |
| Designation |
HOD and PG Professor |
| Affiliation |
Government Nizamia Tibbi College And General Hospital |
| Address |
PG Department Of Kulliyat e Tibb,Government Nizamia Tibbi College And General Hospital, Charminar, Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9912904786 |
| Fax |
|
| Email |
Yousufmohd96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Nizamia Tibbi College And General Hospital
Charminar hyderabad TELANGANA
500002
INDIA |
|
|
Primary Sponsor
|
| Name |
PG Dept Of Kulliyat e tibb |
| Address |
Govt Nizamia Tibbi College And General Hospital, PG Department Of Kulliyat e Tibb Charminar Hyderabad TELANGANA 500002 INDIA |
| 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 Sana Fatima |
Government Nizamia Tibbi college and general hospital. |
OPD NO 06,PG Department Of Kulliyat e Tibb,Government Nizamia Tibbi College And General Hospital, Charminar, Hyderabad.
Hyderabad
TELANGANA |
8074048665
Sanafatimaaaa99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Govt Nizamia Tibbi College, Charminar, Hyderabad,Telangana State |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
sciatica |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Low back pain radiating toward thigh and foot
2 SLRT positive cases
3 Already diagnosed cases |
|
| ExclusionCriteria |
| Details |
1 Pregnancy and lactation
2 Uncontrolled HTN and Diabetes mellitus
3 Unwilling or inability to comply the requirement of the protocol |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the incidence of sciatica in individuals of different temperament |
4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To conclude & prove the statistical analysis of incidence of Sciatica in individuals of different temperament |
4 WEEKS |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
22/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
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
|
This neuralgic pain is called sciatica in medical science. The sciatica is a painful condition and Syndrome associated with pain in hip joint which radiates to the back of the Thigh, leg, Ankle & Toes.
In our Unani concept our ancient describe The disease Irqunnasa(sciatica) is caused by derangement of humours. |