| CTRI Number |
CTRI/2026/03/106304 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
14/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Unani
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare leech therapy and platelet rich plasma therapy in patients with chronic non healing wounds |
|
Scientific Title of Study
|
Randomized Comparative Clinical Evaluation of Classical Regimen Irsal-i-‘Alaq (Hirudotherapy) versus Platelet-Rich Plasma Therapy in Qurooh-e-Muzmina (Chronic Ulcers) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Areeb |
| Designation |
PG Scholar |
| Affiliation |
Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College and Hospital |
| Address |
Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College
Faculty of Unani Medicine Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9557676664 |
| Fax |
|
| Email |
areebgh6327@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asia Sultana |
| Designation |
Professor |
| Affiliation |
Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College and Hospital |
| Address |
Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College
Faculty of Unani Medicine Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8755199034 |
| Fax |
|
| Email |
aasia.sultana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammad Areeb |
| Designation |
PG Scholar |
| Affiliation |
Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College and Hospital |
| Address |
Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College
Faculty of Unani Medicine Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9557676664 |
| Fax |
|
| Email |
areebgh6327@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College faculty of Unani Medicine
Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
|
|
Primary Sponsor
|
| Name |
Department of Ilaj Bit Tadbeer |
| Address |
Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College faculty of Unani Medicine
Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohammad Areeb |
Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College and Hospital |
Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College and Hospital
Aligarh Muslim University Aligarh
Uttar Pradesh
202002
India
Aligarh
UTTAR PRADESH |
9557676664
areebgh6327@gmail.com |
| Dr Mohammad Areeb |
Department of Plastic Surgery Jawaharlal Nehru Medical College and Hospital |
Department of Plastic Surgery
Jawaharlal Nehru Medical College and Hospital
Aligarh Muslim University
Aligarh Uttar Pradesh
202002
India
Aligarh
UTTAR PRADESH |
9557676664
areebgh6327@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Faculty of Unani Medicine Aligarh Muslim University Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L979||Non-pressure chronic ulcer of unspecified part of lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Leech Therapy |
Leech Therapy will be performed once weekly for a total of 8 sittings over 8 weeks |
| Comparator Agent |
Platelets Rich Plasma (PRP) therapy |
Platelets Rich Plasma (PRP) Therapy will be administered at weekly intervals for a total of 8 sessions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of chronic ulcers
All adult patients from the age of 18yrs
Both genders
Patients having ulcers of grade II to V as per Wagner classification
HbA1C is less than 7 (controlled diabetes)
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Patients having psychological disorders
Immunocompromised patients
Patients on anticoagulant or antiplatelet therapy (aspirin warfarin clopidogrel etc)
Patients of bleeding disorders and Severe anemia (Hb less than 8 g per dL) and hypotension
Platelet dysfunction or platelet count less than 150000 per µL (for PRP group)
Known hypersensitivity to leech saliva or its components (for Leech group)
Patients who refuse to sign the consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the Clinical outcome of Classical Regimen Irsal-i-Alaq
(Hirudotherapy) with Platelets Rich Plasma (PRP) Therapy in Qurooh-e-Muzmina
(Chronic Ulcers)
Evaluate the effects of Platelet Rich Plasma (PRP) Therapy in the management of
Qurooh-e-Muzmina (chronic ulcers)
Evaluate the effects of Irsal-i-Alaq (Hirudotherapy) in the management of
Qurooh-e-Muzmina (chronic ulcers)
To Evaluate the post treatment change in Quality of Life of patients with Qurooh-e
Muzmina (chronic ulcers) |
Baseline and at the end of treatment after 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Biotechnological assessment of leech saliva for characterization |
Baseline
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
05/04/2026 |
| 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="6"
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 randomized, open-label, comparative Phase II clinical trial aims to evaluate the effectiveness of the classical Unani regimen Irsal-i-Alaq (Hirudotherapy) in comparison with Platelet Rich Plasma (PRP) therapy in the management of Qurooh-e-Muzmina (chronic ulcers) Chronic ulcers are wounds that fail to heal within six weeks due to factors such as impaired circulation infection or systemic diseases like diabetes In this study 50 patients aged from18 years with Wagner grade II–V chronic ulcers will be randomly allocated into two groups Group A receiving leech therapy and Group B receiving PRP therapy once weekly for 8 weeks Outcomes will be assessed through clinical parameters including wound size reduction wound healing rate pain score (VAS) granulation tissue formation and quality of life measures The study aims to compare the clinical outcomes of both therapies and evaluate the therapeutic potential of hirudotherapy as a safe and effective treatment option for chronic non-healing ulcers |