A Comparative Clinical Study on Yashadamrita Malahara and 0.03 percent Tacrolimus Ointment in the Management of Atopic Dermatitis Vicharchika in Children An Open Labelled DoubleArm Randomized Controlled Clinical trial

Background Atopic dermatitis is a common chronic inflammatory skin disorder in children. It often has a genetic predisposition and is associated with other allergic conditions such as asthma and allergic rhinitis. The disease typically starts early in life and affects physical appearance, sleep quality, and psychological well-being. Conventional treatment with corticosteroids, antihistamines, and topical immunomodulators provides symptomatic relief but is limited by side effects and relapse on discontinuation.

Ayurvedic Perspective In Ayurveda, a similar condition is described as Vicharchika, a type of Kshudra Kushtha. It is characterized by itching, eruptions, discoloration, and oozing. Yashadamrita Malahara is a classical Ayurvedic topical formulation containing Yashada Bhasma. It possesses wound healing, anti-pruritic, and skin nourishing properties. Modern studies suggest that zinc-based formulations also have anti-inflammatory and antimicrobial effects, supporting their use in eczema-like conditions.

Need for Study Despite its traditional use, Yashadamrita Malahara has not been systematically evaluated in children with atopic dermatitis. There is a need for safe, effective, and child-friendly treatments that offer long-term relief and reduce dependency on conventional drugs.

RESEARCH QUESTION:

What is the effect of local application of Y**ashadamrita Malhara in comparison to 0.03% Tacrolimus ointment in the management of Atopic Dermatitis (Vicharchika) in children between 3 to 12 years of age over a treatment period of 6 weeks?

HYPOTHESIS:

Local application of Yashadamrita Malhara applied twice a day (QS) will be more effective as compared to the local application of 0.03% Tacrolimus ointment applied twice a day (QS) in the management of Atopic Dermatitis (Vicharchika)in children between 3 to 12 years of age over 6 weeks of treatment.

NULL HYPOTHESIS (H0):

Local application of Y**ashadamrita Malhara is not more effective as compared to the local application of 0.03% Tacrolimus ointment in the management of Atopic Dermatitis (Vicharchika) in children between 3 to 12 years of age over 6 weeks of treatment.

ALTERNATE HYPOTHESIS (H1):

Local application of Y**ashadamrita Malhara is more effective as compared to the local application of 0.03% Tacrolimus ointment in the management of Atopic Dermatitis (Vicharchika) in children between 03 to 12 years of age over 6 weeks of treatment.

AIM AND OBJECTIVE OF RESEARCH STUDY

The Aim of the present study

To evaluate the clinical efficacy and safety of Yashadamrita Malhara in the management of Atopic Dermatitis (Vicharchika) in children aged 3 to 12 years, based on the signs and symptoms reduction, improvement in SCORAD INDEX parameters.

OBJECTIVES OF THE RESEARCH PROJECT:

PRIMARY OBJECTIVES:

1.To evaluate the efficacy of Yashadamrita Malahara in comparison to 0.03% Tacrolimus Ointment in reducing the SCORAD score over 6 weeks in children aged 3–12 years with Atopic Dermatitis (Vicharchika).

SECONDARY OBJECTIVES:

1.To assess improvement in skin hydration using Corneometer.

2.To assess changes in skin Ph.

3.To assess reduction in TEWL using Tewameter.

4. To assess improvement in Subjective symptom relief

5. To assess changes in laboratory parameters [Serum IgE]

6.To assess the safety profile of Yashadamrita Malahara by observing and documenting any adverse effects.

Study Design

Open labelled randomized double arm controlled clinical trial with 1:1 allocation

Setting and Location Outpatient Department of Kaumarabhritya All India Institute of Ayurveda New Delhi

Sample Size 94 participants, 47 in each group considering 10 percent loss to follow up

Participants Children aged 3 to 12 years diagnosed with Atopic Dermatitis or Vicharchika based on Hanifin and Rajka criteria and Ayurvedic features. Excluding congenital anomalies chronic systemic illness recent corticosteroid use or refusal of consent

Interventions Group A Yashadamrita Malahara applied externally twice daily for 6 weeks Group B Tacrolimus ointment 0.03 percent applied externally twice daily for 6 weeks Both groups will undergo Mridu kostha shodhana with Manibhadra Gudam before intervention

Follow up Treatment duration 6 weeks with post treatment follow up for 4 weeks up to 10th week

Outcome Measures Primary outcome Reduction in SCORAD Index and improvement in Ayurvedic clinical features of Vicharchika Secondary outcomes Improvement in corneal hydration skin pH transepidermal water loss serum IgE levels and subjective symptom relief

Randomization Simple randomization by computer generated table. Allocation ratio 1:1

Blinding Open label no masking

Investigations CBC with ESR and serum IgE.

Safety and Monitoring Adverse drug reactions will be reported to pharmacovigilance center AIIA and managed accordingly. Compliance chart will be maintained. Minimum 80 percent compliance required

Duration 6 week intervention with 4 week follow up. Total study duration about 10 weeks per participant

Ethics Informed written consent and assent obtained. CTRI registration before recruitment. Confidentiality maintained. Post trial access ensured

Experimental Arm In vitro study using HaCaT keratinocyte cell line at Amity Institute of Molecular Medicine and Stem Cell Research in collaboration with AIIA. TNF alpha and IFN gamma induced model will assess effect of Yashadamrita Malahara on ROS and cytokine expression IL6 IL13 CCL17

Budget Approximately INR 2.2 lakh including drug preparation procurement laboratory tests and experimental study