CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/10/096142 [Registered on: 16/10/2025] Trial Registered Prospectively

Last Modified On:

16/10/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A study comparing Yashadamrita Malahara (Ayurvedic ointment) and Tacrolimus ointment in the treatment of children with Atopic Dermatitis.

Scientific Title of Study

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

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Salalkar Samartha Babasaheb
Designation	PG Scholar
Affiliation	All India Institute of Ayurveda, New Delhi
Address	Room No 406, Department Of Kaumarabhritya, Academic Block, All India Institute Of Ayurveda, Gautampuri Sarita Vihar,New Delhi 110076 south DELHI India South DELHI 110076 India
Phone	7447239436
Fax
Email	sbsalalkar96@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Prashant Kumar Gupta
Designation	Assistant Professor, Department of Kaumarabhritya
Affiliation	All India Institute of Ayurveda, New Delhi
Address	Room No 403, Department Of Kaumarabhritya, Academic Block, All India Institute Of Ayurveda, Gautampuri Sarita Vihar,New Delhi 110076 south DELHI India South DELHI 110076 India
Phone	9990988860
Fax
Email	prashantgupta27@gmail.com

Details of Contact Person
Public Query

Name	Salalkar Samartha Babasaheb
Designation	PG Scholar
Affiliation	All India Institute of Ayurveda, New Delhi
Address	Room No 406, Department Of Kaumarabhritya, Academic Block, All India Institute Of Ayurveda, Gautampuri Sarita Vihar,New Delhi 110076 south DELHI India South DELHI 110076 India
Phone	7447239436
Fax
Email	sbsalalkar96@gmail.com

Source of Monetary or Material Support

All India Institute of Ayurveda, Gautampuri, Sarita vihar, New Delhi 110076 India

Primary Sponsor

Name	All India Institute of Ayurveda
Address	All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi, 110076.
Type of Sponsor	Government medical college

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 Salalkar Samartha Babasaheb	All India Institute of Ayurveda, New Delhi	Room No.406, Department of Kaumarabhritya, Academic Block, All India Institute of Ayurveda, Gautampuri, Sarita vihar, New Delhi, India South DELHI	7447239436 sbsalalkar96@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:L20\|\|Atopic dermatitis. Ayurveda Condition: VICARCIKA,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm (Non Ayurveda)		-	Tacrolimus Oint. 0.03%	Type of Comparator: Active control (standard conventional treatment) Dosage Form: Topical ointment Route of Administration: Apply thin layer over affected areas of skin Dosage and Frequency: Twice daily application for six weeks
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Yashadamrita Malhara, Reference: Rasa Tarangini, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 6 Weeks, Reference: No, Route: -, Dosage Form: Malahara/ Ointment/ Balm, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:

Inclusion Criteria

Age From	3.00 Year(s)
Age To	12.00 Year(s)
Gender	Both
Details	1. Patients between 3 to 12 years of age, irrespective of gender, socio-economic status and food habits. 2. Clinically diagnosed with Vicharchika based on classical Ayurvedic features such as Kandu (itching), Raktavarnata (erythema), Rukshata (dryness of skin), Shyavata (discoloration), and Pidaka (plaques)./ Atopic Dermatitis (Hanifin and Rajka Criteria). 3. Willing to give assent/consent for the trial.

ExclusionCriteria

Details

1. Children with congenital anomalies, chronic ailments such as tuberculosis, malignancy, cardiac, and renal disorders
2. Children who have received systemic corticosteroids (oral or injectable) within 28 days prior to baseline/randomization will be excluded.
3. Children having any other associated illness, like diarrhoea, and acute febrile or other disorders will be excluded from the study.
4. Parents of the patient not willing to participate in the trial.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Efficacy of Yashadamrita Malhara in management of clinical features of Atopic Dermatitis (Vicharchika) compairing reduction in SCORAD Index scores and improvement in clinical features of Vicharchika as per classical texts of Ayurveda	Day 0, 2nd week, 4th week, 6th week, 8th week,10th week.

Secondary Outcome

Outcome	TimePoints
To assess improvement in corneal hydration using Corneometer.	Day 0, 2nd week, 4th week, 6th week, 8th week,10th week.
To assess changes in skin pH	Day 0, 2nd week, 4th week, 6th week, 8th week,10th week.
To assess reduction in TEWL using Tewameter	Day 0, 2nd week, 4th week, 6th week, 8th week,10th week.
To assess improvement in Subjective symptom relief.	Day 0, 2nd week, 4th week, 6th week, 8th week,10th week.
To assess changes in Serum IgE levels.	Day 0, 6th week, 10th week.

Target Sample Size

Total Sample Size="94"
Sample Size from India="94"
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

Date of First Enrollment (India)

01/01/2026

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="0"
Months="2"
Days="14"

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

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 Yashadamrita 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 Yashadamrita 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 Yashadamrita 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