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CTRI Number  CTRI/2024/06/069534 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 24/06/2024
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   Clinical Study On The Comparative Effects Of Zimad Versus Thuja Ointment In Verruca Vulgaris (Thaalil) 
Scientific Title of Study   Clinical Study On The Comparative Efficacy Of Zimad Versus Thuja Ointment In Verruca Vulgaris (Thaalil) 
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 Jagesh Kumar 
Designation  PG Scholar  
Affiliation  National Institute Of Unani Medicine 
Address  Dept of Amraze Jild Wa Tazeeniyat National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India

Bangalore
KARNATAKA
560091
India 
Phone  09205225615  
Fax    
Email  drjagesh786@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Mohd Aleemuddin Quamri 
Designation  HOD -Dept. of Amraze Jild wa Tazeeniyat & Moalajat (i/c) 
Affiliation  National Institute of Unani Medicine 
Address  Dept of Amraze Jild Wa Tazeeniyat National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India

Bangalore
KARNATAKA
560091
India 
Phone  9341072974  
Fax    
Email  drmaquamri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Mohd Aleemuddin Quamri 
Designation  HOD -Dept. of Amraze Jild wa Tazeeniyat & Moalajat (i/c) 
Affiliation  National Institute of Unani Medicine 
Address  Dept of Amraze Jild Wa Tazeeniyat National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India

Bangalore
KARNATAKA
560091
India 
Phone  9341072974  
Fax    
Email  drmaquamri@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka  
 
Primary Sponsor  
Name  National Institute Of Unani Medicine 
Address  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 
Dr Jagesh Kumar  National Institute Of Unani Medicine   Amraze Jild Wa Tazeeniyat OPD/IPD/NIUM Hospital Bangalore
Bangalore
KARNATAKA 
9205225615

drjagesh786@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: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Thuja Ointment  Clinical study on the comparative Efficacy of Ḍimād versus Thuja ointment in Verruca vulgaris (ThaʼālÄ«l)Drugs will be cleaned from unwanted impurities and powdered to make Ḍimād.It Will Be applied on the affected area in a required quantity upto 14th day of follow up 
Intervention  Zimaad (Ointment)Of Shab-i-yemeni biryan, Tinkar biryan, Noshadar Kaat safaid / katthaa  Clinical study on the comparative Efficacy of Ḍimād versus Thuja ointment in Verruca vulgaris (ThaʼālÄ«l) 2gm of Zimaad Will Be Applied Over The Patients Affected Area in a required quantity for 14 days  
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  •Includes all gender with age More then 10 years and above.
•Diagnosed cases of common warts over hands, head, neck and face.
•Subjects with Warts size of Less then 10 mm and Less then 10 in number
 
 
ExclusionCriteria 
Details  •All gender patients below 10 years.
•Known cases of other than common warts, infectious dermatoses, immunocompromised
•Subjects who received treatment for warts in the past 2 weeks.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Complete Removal Of lesions (warts)   0th,3rd,5th,7th,14th days 
 
Secondary Outcome  
Outcome  TimePoints 
•Photography of lesion
•Visual analogue scales (VAS)
•Patient satisfaction scale (PSS)
 
0th,3rd,5th,7th,14th days 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   10/07/2024 
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  

Need of the Study

Common warts (Verruca vulgaris) are the most frequently seen viral mucocutaneous infections in humans caused by Human Papilloma Virus, HPV-1 and 2.1 Common warts are the Papular lesions with a coarse roughened surface often seen on the hands and feet, but also on other sites.2

Cutaneous warts can occur at any age but are uncommon in infancy and more common among teenagers and adults, especially in meat, poultry, and fish handlers. The incidence was 2- 20% in school children and about 10% in young adults and decreases with age.3

About two-thirds of the warts resolve spontaneously but most patients seek treatment because of their unsightly appearance, rapidly increasing number, or associated tenderness.4

Warts have a considerable impact on the quality of life due to physical pain, awkwardness, persistence, and recurrence.5 Though chemical cautery, cryotherapy, electrocautery, excision, bleomycin sulfate injection, laser vaporization, and photodynamic therapy are still considered the primary treatment modalities, none of them can guarantee a cure and recurrence is common.4 Salicylic acid is unsuitable for use in extensive warts because of the potential risk of systemic toxicity, especially in children and trichloroacetic acid causes a slow burning sensation for 1–5-minute and  pain.6

In Unani medicine, there are many single drugs described in classical texts book for the management of Thaʼālīl (warts). like chuna, zarneik-zard(haratala), Noshadar, mawez munaqa, Tinkar,Mazu,Shab-i-yameni, Tukhm Jarjeer apart from this Munḍij-i-Balgham, Munḍij-i-Sawdāʼ, Muṣffī-i-Dam can be given Therefore, the aims of the study is to prepare an effective medicine for Thaʼālīl. The drug used in present study is polyherbal formulation (Ḍimād) is effective in various types of Thaʼālīl (warts).The Ḍimād consist of shab-i-yemeni biryan,tinkar biryan,noshadar,kaat safaid. Therefore, the title “Clinical study on the comparative Efficacy of Ḍimād versus Thuja ointment in Verruca vulgaris (Thaʼālīl)”

Review of literature:

Common warts are single /multiple, firm papules with verrucous(hyperkeratotic), dry surface, often stippled with black dots.7 Verruca vulgaris is characterized by focal proliferation of keratinocytes due to infection with the human papillomavirus (HPV) and can occur anywhere in the body.8,9Common warts typically appear as exophytic, hyperkeratotic, dome-shaped papules of varying sizes with a rough surface on exposed areas of the body, such as the fingers, palms, elbows, face, and knees, or as filiform variants mainly around the lips, eyelids, and nostrils.10,11 Human papillomaviruses (HPVs) are a group of small DNA viruses that cause a variety of benign and malignant lesions of the skin and mucous membranes. The most commonly recognized HPV-associated diseases include warts at anogenital sites (condyloma acuminatum), other skin surfaces (common warts or verruca vulgaris), and the plantar surface of the foot (verruca plantaris).12

Warts are benign proliferations of skin and mucosa caused by human papillomaviruses (HPVs). More than 150 types of HPV have been identified. Certain types of HPV occur at particular anatomic sites, however, warts of any HPV type may be found at any site. Variants include common warts, genital warts, flat warts, and deep palmoplantar warts. Common warts, known as verruca vulgaris, are hard papules that range in size from 1 mm to more than 1 cm with a rough scaly surface and can occur anywhere on the body. Warts are transmitted by direct contact, and disruption of the epithelial barrier is a predisposing factor.12 HPV is a member of the family Papillomaviridae. Like all papillomaviruses, HPV is non-enveloped, measures 55 nm in diameter, and has a double-stranded circular DNA genome of approximately 7900 base pairs enclosed by an icosahedral capsid.12 Papillomaviruses are classified taxonomically by genus (Greek letters) and species (numbered), each containing one or more types. Most HPV types are included in two large genera: alpha (primarily mucosal or genital types) and beta (primarily cutaneous types).12 Warts are the most common viral infections which are encountered in dermatological practice.13

They are benign epidermal proliferations that have been recognized for thousands of years.14 It is by far the most prevalent disease in the world, representing nearly one in every ten women.15 The virus first targets epidermal basal cells and then enters a dormant phase of slow multiplication.16

In the Unani System of Medicine, warts are inverted, open bumps, and hanging. warts are called lentils (masoor) like hantiya, wheat, and barley.17 There are two types one is smooth and soft and the other is rough and hard which is called masamir. The reason for Thaʼālīl rutb is balgham ghaleez, which is similar to Sawdāʼ or simply the reason is only black bile.18 Warts are dry Khilt or non-viscous matter, which becomes hard due to the excess of dryness in its place. Thaʼālīl also called warts whose ends are round and roots are thin and sometimes they are spread on the skin like the ends of nails. corns are hard growths that occur on the joints of the hands and feet.19

Masāmīr/Tha’ālīl (warts) are Arabic words used in the Unani System of medicine for a diseased condition called warts. It is a hard, grainy skin growth fastened in between the dermis and underneath muscles, its color is whitish, it is oval or rounded in shape, and it is placed inversely in the skin as a nail, that’s the reason it is called Masāmīr.20

Its commonest site is the fingers of the hands and soles, because this person gets trouble walking and touching.20 Type of mass hard growth on the body, when its margin is rounded is called Masāmīr (nail), but meandering and irregular imagination is called Qarn (corn/horn). Its material is thick, phlegmatic, and sticky.21

Drug Review: The polyherbal formulation (Ḍimād) consists of Alum (Shab-i-Yemeni)

externally as a caustic,haemostatic and antiseptic. As a caustic. Alum is used in various combinations for different diseases: e-g. haematuria,haemoptysis,and leucorrhoea.22 Sodium biborate (Tinkar) Externally as a, antiseptic,astringent.23 ammonium chloride (Noshadar) externally as a anti-inflammatory.24 Acacia catechu(kaat/katthaa) externally as a astringent and haemostatic.25

Objective of the study:

To assess the comparative efficacy of the Topical Application of Ḍimād versus Thuja ointment in Verruca vulgaris (Thaʼālīl).

 

 
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