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CTRI Number  CTRI/2024/06/068430 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 01/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment of Non Healing Ulcers With Unani Drugs(Kundur, Aelwa, Dam-ul-akhawain, Anzaroot)In Human beings 
Scientific Title of Study   A Randomized, Standard Controlled Clinical Trial Of Unani Formulation (Kundur, Aelwa, Dam-ul- akhawain, Anzaroot) In Non healing 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  ANAM AFSAR 
Designation  PG Scholar 
Affiliation  National Institute Of Unani Medicine Banglore 
Address  Department Of Ilmul Jarahat National Institute Of Unani Mediine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India

Bangalore
KARNATAKA
560091
India 
Phone  9711965397  
Fax    
Email  dranam98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  ProfSaiyad Shah Alam 
Designation  HOD Ilmul Jarahat 
Affiliation  National Institute Of Unani Medicine Banglore 
Address  Department Of Ilmul Jarahat National Institute Of Unani Mediine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India

Bangalore
KARNATAKA
560091
India 
Phone  8792683039  
Fax    
Email  shahalam1971@gmail.com  
 
Details of Contact Person
Public Query  
Name  ProfSaiyad Shah Alam 
Designation  HOD Ilmul Jarahat 
Affiliation  National Institute Of Unani Medicine Banglore 
Address  Department Of Ilmul Jarahat National Institute Of Unani Mediine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India


KARNATAKA
560091
India 
Phone  8792683039  
Fax    
Email  shahalam1971@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India  
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  Department Of Ilmul Jarahat National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anam Afsar  National Institute Of Unani Medicine   Patient attending the OPD and IPD, department of Ilmul Jarahat,National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India
Bangalore
KARNATAKA 		 9711965397

dranam98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the Institutional Ethics Committee (|EC) for Biomedical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L978||Non-pressure chronic ulcer of other part of lower leg,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ointment  The patient of the control group with Povidone-iodine 5%(Betadine). The dressing will be changed on alternate days. The wound will be assessed on every 0th,15th 30th, and 45th day during treatment for wound are measured by graph paper in square centimeters or millimeters,appearance of granulation tissue, photography of affected part,(after the written consent of patients), covering of epithelial tissue, depth of wound by Wagner’s Grading Scale, the colour of surrounding skin and pain.  
Intervention  zaroor  All dried crude drugs (Kundur, Aelwa, Dam-ul-akhawain,Anzaroot) will be cleaned, crushed, and grinded with the help of an electric grinder to get the fine powder and each drug will be mixed in equal quantities in NIUM pharmacy, according to “Kitab al-Mukhtarat fi’l Tibb”. For dressing the wound first cleaning will be done with normal saline under all aseptic conditions, dried with a gauze piece and powder of research drug will be sprinkled on the wound then it will be covered with a dry gauze piece and wrapped with a cotton bandage. Dressing of wounds will be done on every alternate day. 0th,15th,30th,45th 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) All genders.
2) Ulcers not healing for more than 6 weeks.
3) Wagner’s grading 0,1and 2 ulcers.
4) Patient in age group 18-70 years.
 
 
ExclusionCriteria 
Details  1) Gangrenous and Malignant ulcers.
2) Pregnant and lactating women.
3) Patient with any severe systemic disease.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) Discharge
2) Pain (Yes/No)
3) No.of wound 		 Alternate day starting from 0th day 
 
Secondary Outcome  
Outcome  TimePoints 
VAS scoring of pain.
•Wagner’s gradingofulcer.
•Areaofwoundinsquarecentimetres.
•Appearance of healthy granulation tissue
•Epithelisation in percentage
•Depth of wound in centimetres
•No. of days for healing 		 0th,15th,30th,45th 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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/ Phase 3 
Date of First Enrollment (India)   15/06/2024 
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="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  

An ulcer is a break in the continuity of the covering epithelium either skin or mucous membrane due to molecular death of the surface epithelium or its traumatic removal.1Non-healing ulcers are those that do not heal after 6 weeks of conservative therapy.2 Chronic non-healing ulcers are a major health issue that affects an estimated 2-6 million people in the United States alone, with global prevalence ranging from 1.9 to 13.1 %.3 Leg ulcers affect approximately 1-2% of the population. 

The management of non-healing ulcers comprises, the treatment of the underlying cause, wound cleansing and dressing, personal hygiene, infection management, and wound closure.3 Many chronic ulcers refuse to heal or linger for months/years despite therapy, and/or relapse after healing, necessitating the use of advanced wound care therapies such as Hyperbaric Oxygen therapy, skin grafting, Gene therapy, Stem cell therapy, Shock wave, VAC (Vacuum aided closure), and surgicalmanagementasangioplastyandreconstructivesurgeryetc3.; are available and costly treatments for non-healing ulcers.

OBJECTIVE OF STUDY:

To Assess the efficacy of the Unani formulation (Kundur, Aelwa, Dam-ul-Akhawain, Anzaroot) in comparison to Povidone iodine 5% ointment. 
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