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CTRI Number  CTRI/2025/06/089024 [Registered on: 18/06/2025] Trial Registered Prospectively
Last Modified On: 18/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Eczema (Atopic dermatitis) 
Scientific Title of Study   An open labelled comparative clinical trial to evaluate the combined effect of vamanottara siravyadha and virechanottara siravyadha followed by kushtavairi lepa in vicharchika w.s.r to eczema. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Santoshi  
Designation  panchakarma Post Graduate Scholar 
Affiliation  Taranath Government Ayurveda Medical college and hospital 
Address  Taranath govt ayuerveda medical collage and hospital, dr rajkumar road ballari

Bellary
KARNATAKA
583101
India 
Phone  8951469009  
Fax    
Email  santoshibiradar162@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Doddabasayya kendadamath 
Designation  Proffesor 
Affiliation  Taranath Government Ayurveda Medical college and hospital 
Address  Taranath govt ayuerveda medical collage and hospital, dr rajkumar road ballari

Bellary
KARNATAKA
583101
India 
Phone  9986916015  
Fax    
Email  drkendadamath@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Santoshi  
Designation  Panchakarma Post Graduate Scholar 
Affiliation  Taranath Government Ayurveda Medical college and hospital 
Address  Taranath govt ayuerveda medical collage and hospital, dr rajkumar road ballari

Bellary
KARNATAKA
583101
India 
Phone  8951469009  
Fax    
Email  santoshibiradar162@gmail.com  
 
Source of Monetary or Material Support  
Department of PG studies in panchakarma ,room no 6, Taranath govt ayurveda medical collage and hospital Ballari-583101 
 
Primary Sponsor  
Name  Pandit Taranath Government Ayurveda Medical college and hospital ballari 
Address  Taranath govt ayurveda medical collage and hospital  
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 Santoshi  Taranath Government Ayurveda Medical college,Ballary  Taranath govt ayuerveda medical collage and hospital, dr rajkumar road ballari
Bellary
KARNATAKA 		 08951469009

santoshibiradar162@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Taranath government ayurveda medical college institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: charaka chikitsa 7, Procedure details: 25 day)
(1) Medicine Name: kutajadi yoga, Reference: ashtanga sangraha chikitsa 21, Route: Oral, Dosage Form: Churna/ Powder, Dose: 15(g), Frequency: od, Duration: 1 Days
2Comparator ArmProcedure-Virechana (Procedure Reference: charaka chikitsa 7, Procedure details: 27days)
(1) Medicine Name: phalatrikadi kwatha, Reference: harita samhita 39, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
improvement in signs amd symptoms of vicharchika   4 weeks 4 days 
 
Secondary Outcome  
Outcome  TimePoints 
improvemnrt in EASI score   32 DAYS  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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/ Phase 3 
Date of First Enrollment (India)   30/06/2025 
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="1"
Days="17" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

          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
 
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