MedPath

Eczema (Atopic dermatitis)

Phase 2/3
Not yet recruiting
Conditions
Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA,
Registration Number
CTRI/2025/06/089024
Lead Sponsor
Pandit Taranath Government Ayurveda Medical college and hospital ballari
Brief Summary

Vicharchika is one among the kshudra kushta caused due to dushti of sapta dushya’s they are tridosha, twak, rakta, mamsa and lasika1. It is  characterised by kandu, pidaka shyava varna, bahusrava,2 raga, ruja, and rukshata.3

Vicharchika simulates to Eczema in modern science. Eczema is charecterised by itching, erythema, vesicles, blisters, exudation, and crusting in acute stage followed by hyperkeratosis and lichenification in chronic stage4. Prevalance rate of it globally is 2-10% of adults and 30% of children  with male to female ratio 1:1.45 and in India 0.98% to 9.2% including pediatric and adult population.6

Treatment for Eczema consists of oral and topical Corticosteroids, antihistamines, topical immunomodulators, phototherapy by UVB rays which gives symptomatic relief but long term use of topical steroids causes local cutaneous immune suppression, thinning of skin, stretch marks and redness of skin7. No treatment can eliminate eczema completely so there is a hope in ayurveda.

Kushta being tridoshaja vikara shodhana followed by lepa chikitsa plays vital role in its treatment. As vicharchika is kaphadosha pradhana and charaka acharya told vamanam sleshmottereshu kushteshu8 here in one group vamana is adopted. And in another group virechana is adopted as pitta dosha is mala of rakta and kushta being raktapradoshaja vikara9 malaroopi pitta is increased in body and to eliminate it virechana is best.

Khadiradi ghrita is used for snehapana for both vamana and virechana as it is sakala kushtahara according to harita10, followed by sarvanga abhyanga with murchita tila taila and bashpa sweda. For vamana, kutajadi yoga11having tikta kashaya rasa drugs with kledahara properties is adopted and for virechana phalatrikadi kwatha which does pittashodhana, raktaprasadana is adopted.12

Among the various methods of raktamokshana siravyadha is considered as it expels vitiated blood from all over body13 and sushruta acharya has explained twak dosha will not occur if one undergoes raktamokshana regularly.14 so it is adopted after vamana and virechana in both the groups.

Acharya Charaka has described Lepa as "Sadyah Siddhi Kara" if applied after Kaya shodhana and rakta mokshana15. Kushtavairi is adopted after siravyadha in both the groups which is sarvavidha kushta nashaka according to govind das sen.16.

Hence the present study is undertaken to evaluate the effect of vamanottara siravyadha followed by kushtavairi lepa in one arm and in another arm virechanottara siravyadha followed by kushtavairi lepa in vicharchika w.s.r to eczema and the study entitled as,

**“AN OPEN LABELED COMPARATIVE CLINICAL TRIAL TO EVALUATE THE COMBINED EFFECT OF VAMANOTTARA SIRAVYADHA AND VIRECHANOTTARA SIRAVYDHA, FOLLOWED BY KUSHTAVAIRI LEPA IN VICHARCHIKA W.S.R TO ECZEMA.”** is undertaken.

**OBJECTIVES OF THE STUDY****:**·       To evaluate the combined effect of vamanottara siravyadha followed by kushtavairi lepa in Vicharchika.

·       To evaluate the combined effect of virechanottara siravyadha followed by kushta vairi lepa in Vicharchika.

To compare the effect of Vamanottara Siravydha followed by kushtavairi lepa and virechanottara siravyadha followed by kushtavairi lepa in Vicharchika w. s. r to Eczema

**A.** **Study design:**  A randomised open labelled comparative clinical study.

**Sampling** **size and grouping :**  Total no.of patient 40, each group containing 20 patients who fulfill the inclusion criteria should be selected and assigned randomly.

| | | |

| --- | --- | --- |

|Group

No of patients

Intervention

|Group A

20

Vamanottara siravyadha

followed  kushtavairi lepa.

|Group B

20

Virechanottara siravyadha

followed by kushtavairi lepa

 **I.** **Subjective criteria:**

| | | |

| --- | --- | --- |

|**SYMPTOMS**

**SEVERITY**

**GRADE**

|**KANDU**

No itching

0

|Mild itching not disturbing normal activity

1

|Occasional itching disturbs normal activity

2

|Itching present continuously & even disturbing sleep

3

  

| | | |

| --- | --- | --- |

|**PIDAKA**

No eruption in the lesion

0

|Scanty eruptions in few lesions

1

|Scanty eruptions in at least half of the lesion

2

|All the lesions full of eruption

3

  

| | | |

| --- | --- | --- |

|**SHYAVA VARNA**

Nearly normal skin colour

0

|Brownish red discoloration

1

|Blackish red discoloration

2

|Blackish discoloration

3

  

| | | |

| --- | --- | --- |

|**SRAVA**

No discharge

0

|Occasional discharge after itching

1

|Occasional oozing without itching

2

|Excessive oozing making clothes wet

3

  

| | | |

| --- | --- | --- |

|**RUKSHATA**

No dryness

0

|Dryness with rough skin (ruksha)

1

|Dryness with scaling (khara)

2

|Dryness with cracking (parusha)

3

 

| | | |

| --- | --- | --- |

|RAGA

No thickening of skin

0

|Thickening of skin but no crisscross markings.

1

|Thickening with crisscross markings.

2

|Severe lichenification.

3

**I.** **OBJECTIVE CRITERIA:**

**EASI (Eczema Area and Severity Index) score:**

| | |

| --- | --- |

|**AREA SCORE**

**Percentage of skin affected by eczema in each region**

|0

No eczema in this region

|1

1-9%

|2

10-29%

|3

30-49%

|4

50-69%

|5

70-89%

|6

90-100% : The entire region is affected by eczema

 

| | |

| --- | --- |

|**ERYTHEMA**

**( E )**

|0

None

|1-MILD

Faintly detectable erythema: very light pink

|2-MODERATE

Dull red clearly distinguishable

|3-SEVERE

Deep/dark red

 

| | |

| --- | --- |

|**INFILTRATION OR PAPULATION**

**( I )**

|0

None

|1-MILD

Barely perceptible elevation

|2-MODERATE

Clearly perceptible elevation but not extensive

|3-SEVERE

Marked and extensive elevation

 

| | |

| --- | --- |

|**EXCORIATION**

**( Ex )**

|0

None

|1-MILD

Scant Evidence Of Excoriation With No Sign Of Deeper Skin Damage (Erosion, Crust)

|2-MODERATE

Severe linear marks of skin with showing evidence of deeper skin injury (erosion, crust)

|3-SEVERE

May erosive or crustly lesion

 

| | |

| --- | --- |

|**LICHENFICATION**

**( L )**

|0

None

|1-MILD

Slight thickening of the skin dissemble only by touch and with skin marking minimally exaggerated

|2-MODERATE

Define thickening of the skin with skin marking exaggerated so that they form a Criss-cross pattern

|3-SEVERE

Thickened indurated skin with skin marking visibly portraying an exaggerated Crisscross pattern

  

| | | | |

| --- | --- | --- | --- |

|Head/Neck

E+I+Ex+L x Area x 0.1

(  +   +   +   ) x   x0.1

 

|Upper Limb

E+I+Ex+L x Area x 0.2

(  +   +   +   ) x   x0.2

 

|Trunk

E+I+Ex+L x Area x 0.3

(  +   +   +   ) x   x0.3

 

|Lower Limb

E+I+Ex+L x Area x 0.4

(  +   +   +   ) x   x0.4

 

|EASI

Sum Of All above body Area

 Total score

**Overall assessment**

·     Complete remission - score is 0 after treatment .

·     Very good improvement – > 75%

·     Good improvement -50% - 75%

·     Moderate improvement -25% - 50%

·     Mild improvement – up to 25%

No improvement – No reduction in score after treatment

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
20
Inclusion Criteria

Patients presenting with signs & symptoms of Vicharchika (Eczema) of either sex will be selected Patients between the age group 18 to 60 years Patients with normal limit of bleeding and clotting time Patients fit for vamana virechana and siravyadha.

Exclusion Criteria

Patients suffering from systemic illness like uncontrolled diabetes mellitus and hypertension Patients with anemia, where Hb% less than 9gm% Pregnant women & Lactating women Patients are suffering from HIV and HbSAg.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
improvement in signs amd symptoms of vicharchika4 weeks 4 days
Secondary Outcome Measures
NameTimeMethod
improvemnrt in EASI score32 DAYS

Trial Locations

Locations (1)

Taranath Government Ayurveda Medical college,Ballary

🇮🇳

Bellary, KARNATAKA, India

Taranath Government Ayurveda Medical college,Ballary
🇮🇳Bellary, KARNATAKA, India
Dr Santoshi
Principal investigator
08951469009
santoshibiradar162@gmail.com

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