| CTRI Number |
CTRI/2024/04/065690 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Cause and pathogenesis of knee osteoarthritis |
|
Scientific Title of Study
|
Study of assosiation between biochemical & haematological parameters and Su-i-Mizaj in etiopathogenesis of Waja-al-Rukba |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TAYYABA KHATOON |
| Designation |
PG SCHOLAR |
| Affiliation |
Ajmal khan tibbiya college |
| Address |
Department of Ilmul Amraz, Ajmal Khan tibbiya college, Aligarh muslim university, Aligarh.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9639528528 |
| Fax |
|
| Email |
drtayyabanaved@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ataullah Fahad |
| Designation |
Assistant professor |
| Affiliation |
Ajmal khan tibbiya college |
| Address |
Department of Ilmul Amraz, Ajmal khan tibbiya college, Aligarh muslim university, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9639528528 |
| Fax |
|
| Email |
drataullahfahad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
TAYYABA KHATOON |
| Designation |
PG SCHOLAR |
| Affiliation |
ajmal khan tibbiya college |
| Address |
Department of Ilmul Amraz ajmal khan tibbiya college aligarh muslim university aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9639528528 |
| Fax |
|
| Email |
drtayyabanaved@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ilmul Amraz faculty of unani medicine,Aligarh muslim university, Aligarh.Uttar pradesh,India.202002 |
|
|
Primary Sponsor
|
| Name |
Department of Ilmul AMraz |
| Address |
Department of Ilmul Amraz faculty of unani medicine aligarh muslim university aligarh.Uttar pradesh,India.202002 |
| Type of Sponsor |
Government 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 Tayyaba Khatoon |
Ajmal khan tibbiya college |
Department of Ilmul Amraz, Aligarh muslim university
Aligarh
UTTAR PRADESH |
9639528528
drtayyabanaved@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: 0steoarthritis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients with h/o knee joint pain
patients of either gender with age group 40-80 years |
|
| ExclusionCriteria |
| Details |
pregnancy and lactation
h/o any chronic inflammatory diseases
patients with major systemic,endocrine and metabolic diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| cause and pathogenesis of waja-al-rakba |
once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| subjective symptoms |
once |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
23/04/2024 |
| 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="0"
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
|
The recruited patients of Waja-al- Rakba will be included as per inclusion and exclusion criteria, after thorough examination and history taking. Findings will be noted on a Case Record Form (CRF). Each patient will be diagnosed for type of Waja- al-Rakba as per description in classical Unani literatures. In the same manner each patient will be evaluated on self-designed questionnaire based on Ajnase Ashra to ascertain Su-i- Mizaj. Hematological parameters of each patient will be estimated and analyzed.After complition of study the result may be made using suitable statistical test. |