A comparative clinical and antimicrobial study on efficacy of Aragvadha patra lepa vs Chakramarda beeja lepa in Dadru kushtha(Dermatophytosis)

In Ayurveda, several skin conditions are included under the Kushtha Roga category. Kushtha is regarded as one of the eight Mahagads as well.(1)

Kushtha Roga has eighteen types, divided into two categories: Maha Kushtha and Kshudra kushtha. According to ’Acharya Charaka’ and ’Acharya Sushruta,’ Dadru is categorized as a Kshudra Kushtha and a Maha Kushtha respectively. Presenting with the features of circular lesion associated with itching, reddish or brownish-blackish rash, dadru resembles the clinical picture of dermatophytosis.

The dermatophytes are a collection of closely related fungi that can infect humans and other animals by invading keratinized tissue, such as skin, hair, and nails. Commonly known as ringworm infections, dermatophytosis falls under skin infections caused by superficial fungi. The incubation period of this fungi is 7 – 14 days. These fungi thrive in warm and moist environments, making areas such as the groin, feet, and scalp particularly susceptible.

Dermatophyte infections are named based on the anatomical site in which they occur, with the Latin title for that site coming after the word "Tinea”, like Tinea corporis(2).

NEED OF STUDY-

Skin diseases account for over 12.4 percent (8) of all diseases worldwide in which a significant portion of them are caused by fungi, with ringworm responsible for 10 to 15% of global infections at current moment (9). The advent of recurrence and anti–fungal resistance has also added to the impact of the problem. Due to increase in the cases of anti-fungal drug resistance there is a need to test new leads for the effective and safe treatment of dermatophytosis. This study will assess the anti-microbial effect of Aragvadha patra through sensitivity and clinical study in comparison to Chakramarda beeja lepa, both administered with Kanji and Varadi yoga (oral) over a 45-day treatment period in management of Dadru kushtha (Dermatophytosis).To the best of our knowledge no research has been carried out on the efficacy of Aragvadha patra or Varadi yoga in Dadru kushtha (dermatophytosis).This study will compare the efficacy of the drug Aragvadha patra to standard control drug Chakramarda beeja lepa which is well researched drug for its efficacy on Dadru kushtha (dermatophytosis).

AIM-

1.To estimate the clinical efficacy of 45 days of Aragvadha patra lepa applicationwith kanji and Varadi yoga (oral) in comparison to Chakramarda beeja lepa withkanji along with Varadi yoga (oral) in the patients of Dadru kushtha (Dermatophytosis).

2. To assess the anti-microbial activity of Aragvadha Patra and Chakramarda Beeja through sensitivity study.

OBJECTIVES-

INTERVENTIONAL STUDY:

PRIMARY OBJECTIVE:

1. To estimate the clinical efficacy of Aragvadha patra lepa in comparison to *Chakramarda beeja lepa,*both administeredwith kanji and Varadi yoga (oral) in the resolution of signs and symptoms of Dadru kushtha (Dermatophytosis).

SECONDARY OBJECTIVES:

1. To study the KOH mount and culture and sensitivity study of each of the enrolled cases affected area skin scrapings.

2. To assess the improvement in dermatology life quality index in both the groups at the end    of 45 days trial duration.

3. To assess the safety of the study drugs used at the end of 45 days.

4. To record the recurrence at the end of 60 days after the trial completion in both the groups.

IN-VITRO STUDY

PRIMARY OBJECTIVE:

·       To observe the anti-microbial effect of Aragvadha patra and Chakramarda Beeja through sensitivity study.

 OUTCOMES:

INTERVENTIONAL STUDY:

Primary Outcome -

1. Percentage resolution of the clinical signs and symptoms of Dadru kushtha in both the groups after 45 days.

Secondary Outcomes:

Changes in DLQI after treatment in both the groups

The recurrence rates in both treatment groups till 105th day of the study.

Incidence of adverse effects associated with each treatment modality.

IN-VITRO STUDY

Primary Outcome –

·    Anti-microbial effect of drugs using In-vitro study.