跳至主要内容
临床试验/CTRI/2024/06/069534
CTRI/2024/06/069534尚未招募2/3 期

Clinical Study On The Comparative Efficacy Of Zimad Versus Thuja Ointment In Verruca Vulgaris (Thaalil)

National Institute Of Unani Medicine1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年7月10日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
48
试验地点
1
主要终点
Complete Removal Of lesions (warts)

研究概览

简要总结

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 tophysical 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.4Salicylic 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 givenTherefore, 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.10,11Human 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 Sawdāʼor 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).

 

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
10.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •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.

排除标准

  • •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.

结局指标

主要结局

Complete Removal Of lesions (warts)

时间窗: 0th,3rd,5th,7th,14th days

次要结局

  • •Photography of lesion(•Visual analogue scales (VAS))

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Jagesh Kumar

National Institute Of Unani Medicine

研究点 (1)

Loading locations...

相似试验