| CTRI Number |
CTRI/2024/10/074661 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani
Other (Specify) [Leech Therapy (Irsal e Alaq)] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Leech Therapy in Management of Knee Osteoarthritis |
|
Scientific Title of Study
|
Prevalence of Knee Osteoarthritis and Efficacy of Irsal e Alaq (Leech Therapy)in its Management and Potential Role in Improving the Quality of Life:A Hospital Based Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fatma Zarrin |
| Designation |
MD Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Tahaffuzi wa Samaji Tib School of Unani Medical Education and Research Jamia Hamdard
south
DELHI
Jamia Hamdard
New Delhi
South
DELHI
110062
India |
| Phone |
7042103403 |
| Fax |
|
| Email |
fatmazarrin9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Mohd Akram |
| Designation |
Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Tahaffuzi wa Samaji Tib School of Unani Medical Education and Research Jamia Hamdard
south
DELHI
Jamia Hamdard
New Delhi
South
DELHI
110062
India |
| Phone |
9891928622 |
| Fax |
|
| Email |
makram@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Farkhunda Jabin |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Ilaj bil Tadbeer
School of Unani Medical Education and Research Jamia Hamdard
south
DELHI
Jamia Hamdard
New Delhi
South
DELHI
110062
India |
| Phone |
7895924502 |
| Fax |
|
| Email |
drfarkhundajabin@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard
New Delhi-110062
India
|
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Department of Tahaffuzi wa Samaji Tib, School of Unani Medical Education and Research Jamia Hamdard
South
DELHI |
| 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 Fatma Zarrin |
Majeedia Unani Hospital |
Room No.-10, OPD of Tahaffuzi wa Samaji Tib, Jamia Hamdard University,Hamdard Nagar
New Delhi
DELHI |
7042103403
fatmazarrin9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee (JHIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Habbe suranjan |
Patient will receive oral medication of Habbe suranjan 2 tablet twice a day for 28 days |
| Intervention |
Leech Therapy (Irsal e Alaq) with oral medication of Habbe Suranjan |
Duration of Therapy-40 mins
Total sitting-3 patient will receive sitting after sensitivity test on 1st day,14th day and 28th day.along with oral medication therapy of Habbe Suranjan 2 tablets twice a day for 28 days and after two week evaluation for efficacy will be recorded |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients fulfilling the ACR diagnostic criteria
2.Diagnosed Patients of Knee OA in age group of 35 to 65 years
3.Clinically Stable Patients
4.Patients of all gender
5.Patients willing to sign the informed consent form and participate in the trial voluntarily |
|
| ExclusionCriteria |
| Details |
1.Age below 35 and above 65
2.Grade 4 Osteoarthritis in X-ray film(kellgren and Lawrence)
3.Patient on anticoagulant therapy or Hemophiliacs
4.Pregnant women and lactating mothers
5.Subject who are chronically ill patient with infectious diseases
6.Patients who fail to give written consent
Patients taking analgesic or anti-inflammatory drugs for any other disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
WOMAC scale
|
At baseline i.e day 1 and post treatment at 6th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF12v2 Questionnaire (for Quality of Life) |
At baseline i.e. day 1 and post treatment at 6th week |
|
|
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)
|
15/10/2024 |
| 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="3"
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 Hospital based,Quasi-experimental Trial and conducted on Diagnosed patient of knee O.A. from OPD of Majeedia Unani Hospital subjects fulfilling the inclusion criteria (ACR Diagnostic criteria) and willing participant are to be enrolled in the experimental and control group.Group A (Experimental Group) is receiving "Leech Therapy" along with oral medication Therapy of Habbe Suranjan 2 tablets twice daily for 28 days .Leech therapy will be given for 40 minutes for three sittings i.e. on 1st day,14th day,28th day and Group B (control Group) is receiving standard treatment of Habbe suranjan 2 tablets twice a day for 28 days.Patients will be assessed at the baseline I.e. on day 1 and post treatment at 6 week.The findings will be recorded in Case Record Form designed for the study based on clinical examination, along with subjective and objective parameters. |