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CTRI Number  CTRI/2025/03/083077 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Managment of Eczema through Arka Taila and Navkarshika Kwatha. 
Scientific Title of Study   An open labelled single arm prospective clinical trial to evaluate the efficacy of Arka Taila along with Navkarshika Kwatha in management of 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 Shivani Lowanshi 
Designation  MD Scholar 
Affiliation  Govt. Ayurvedic College Nipaniya Rewa 
Address  Dept. Of Samhita Siddhant Govt. Ayurveda College and Hospital Nipaniya Rewa Rewa 486001 MADHYA PARDESH

Rewa
MADHYA PRADESH
486001
India 
Phone  9691379193  
Fax    
Email  shivanilovanshi29@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S N Tiwari 
Designation  Associate Professor 
Affiliation  Govt. Ayurvedic College Nipaniya Rewa 
Address  Dept. of Samhita Siddhant Govt. Ayurveda College and Hospital Nipaniya Rewa Rewa 486001 MADHYA PARDESH

Rewa
MADHYA PRADESH
486001
India 
Phone  7581808285  
Fax    
Email  drsntiwari9@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pravanjan Acharya 
Designation  Professor and HOD 
Affiliation  Govt. Ayurvedic College Nipaniya Rewa 
Address  Dept. of Samhita Siddhant Govt. Ayurveda College and Hospital Nipaniya Rewa Rewa 486001

Rewa
MADHYA PRADESH
486001
India 
Phone  9827459956  
Fax    
Email  dr.pravanjan@gmail.com  
 
Source of Monetary or Material Support  
Govt. Ayurveda College and Hospital Nipaniya Rewa M.P Rewa MADHYA PRADESH 486001 India  
 
Primary Sponsor  
Name  Govt. Ayurvedic College and Hospital Nipaniya Rewa 
Address  Dept. Of Samhita Siddhant Govt. Ayurveda College and Hospital Nipaniya Rewa Rewa 486001 
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 Shivani Lowanshi  Govt. Ayurveda College and Hospital Nipaniya Rewa  Room No. 19 Dept. of Samhita Siddhant, Govt. Ayurveda College and Hospital Nipaniya Rewa Rewa MADHYA PRADESH 486001 India
Rewa
MADHYA PRADESH 
9691379193

shivanilovanshi29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Govt. Ayurveda College and Hospital Nipaniya Rewa  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L309||Dermatitis, unspecified. Ayurveda Condition: VICARCIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Navkarshik kwatha , Reference: Bhaishajya Ratnavali 27/14, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: NA
(2) Medicine Name: Arka Taila, Reference: Sha.M.K. 9/148 , Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: only external application of oil on affected area.
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Age 16-70 years
2.Patient who fulfill the diagnostic criteria. 3.Disease chronicity less than 3 years.
4.Previous diagnosed patients.
5.Patients who have given written consent to participate in the study.
 
 
ExclusionCriteria 
Details  1.Lactating and Pregnant women.
2.Patients who are not willing to give written consent to participate in the study.
3.Patients who have undergone any major or minor surgery.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in subjective parameters like itching, depigmentation, eruption, roughness, burning.
 
from 0 to 21 days 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of trial drugs in improving
the signs, symptoms as per assessment criteria. 
from 0 to 21 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3/ Phase 4 
Date of First Enrollment (India)   25/04/2025 
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="2"
Months="0"
Days="0" 
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  


TITLE-AN OPEN LABELLED SINGLE ARM PROSPECTIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF ARKA TAILA ALONG WITH NAVKARSHIKA  KWATHA  IN MANAGEMENT OF VICHARCHIKA W.S.R. TO ECZEMA

AIM AND OBJECTIVES:

AIM:   To assess the efficacy of arka oil along with navkarshika kwatha in the management of vicharchika.

 OBJECTIVE

To assess the clinical efficacy of external application of Arka Taila along with oral administration of navkarshika  kwatha in relieving various symptoms of Vicharchika.

To elaborate the conceptual details of Vicharchika as per Ayurvedic classics & correlate it with Eczema.

 

 INTRODUCTION -

Kustha is a disease of skin and so to understand the total

etiopathogenesis of disease, normal structure of the skin should be

considered.Tvacha is a sthana of Sparshanendriya. Tvacha, Charma words

are used for the skin in all Ayurvedic classics.

According to Charak, the features of Vicharchika are 

                Kandu,Pidika,Shyvta,Vahushrava.  

  a skin ailment where in eruptions over the skin appear with dark pigmentation, itching and with a profuse discharge.

Skin is the largest sense organ of human body which even covers the other sense organs. It is a very sensitive part of human body. Any pathological change in the external or internal environmental factor shows great effect on skin which leads to improper functioning.

In Ayurveda, all skin diseases are explained under a single heading of Kushtha. All Kushtha occur due to aggravation of Tridoshas.

Vicharchika is a type of Kshudra Kustha occuring mainly due to the imbalance of Kapha doshas according to Charak, Acharya Sushrut mentioned it is mainly due to imbalance of pitta.

 NEED OF THE STUDY: 

      Being skin manifestations, psychological distress can lead to significant depression and social isolation and it affects the personal, social, and economic life of a person.According to WHO, the most common skin diseases are Dermatitis (24.2%) as [chronic dermatitis (16.9%), allergic contact dermatitis  (3.5%), irritant contact dermatitis  (1.2%), seborrheic dermatitis  (1.2%), and stasis dermatitis  (1.5%)], then fungal infections  (17.6%). The prevalence of contact dermatitis was 4.38% among the dermatology OPD attendees. Contact dermatitis was common in the age group of 41 to 50 years. In urban areas, females were more affected than those in rural area.Steroid creams, vitamin D3 cream, PUVA and immune system suppressing medications such as methotrexate(antimetabolite) are the mainstay of treatment of eczema. These modern treatment modalities are not devoid from grave complications mainly in long term use. Owing to these reasons, there is a need for treatment having good efficacy and no toxicity ProfileThis study will therefore, help in filling the gap by establishing the role of arka oil along with navkarshika  kwatha described in Ayurveda in management of vicharchika

STUDY DESIG:

Study Type: Interventional

Purpose: Treatment

Masking: Open Labelled, Clinical trial

Direction: Prospective

End point: Efficacy

No. of Groups: Single Group

Sample size: 40 Patients

 

DRUG DETAILS:

 

   1.Navkarshik Kwatha-  Triphala, Manjistha, Nimba, Vacha, Katurohini, Daruharidra , Vatsadani.  

2.Arka Taila: Haridra Kalka, Shasarpa Taila, Arka Taila. 

Probable Mode of Action of Drugs:

 1.Navkarshik Kwatha-

 katu,tikta kashaya rasa pradhana, with laghu & ruksha guna predominance and six content have ushna veerya,five contents have katu vipaka.

Katu and tikta rasa of Navkarhika  kwatha  katu & tikta rasa act on kapha dosha,laghu & ruksha gunas are kaphashamaka have deepana, pachana karma that helps to improve metabolism by the property of Amapachana.

Ushna veerya of  Navkarshika kawtha act as stroto shodhaka and  kleda shoshaka; eliminate morbid doshas accumulated in the body,addition, laghu and ruksha guna act as kleda shoshaka, mala of kapha dosh.

 

2.Arka Taila: 

Vicharchika is caused due to vitiation of Tridoshas. The dushyasare Twak, Rakta, Mansa & Lasika. It is caused in Bahya Rogamarga.Mode of entry for this is Bahya Rogamrga.

The three components of Arka taila are Arka patra, Haridra, and Sarshapa taila.

Vishaghna and Kusthaghna are active in Arka Patra.in action Haridra is Kuthagna,Vishagan and Varnya.

In action, Sarshapa taila is kandughna and kushtagha.

Arka Taila helps to minimize discharge by TikshnaUshna Guna of Arka, Haridra, and Sarshapa on a local level. Katu Vipaka, Vranashodana, and Vranaropana are attributes of Haridra and SarshapaTaila.

TREATMENT REGIMEN:

 

PROCEDURE 

DRUGS 

DOSES

ROUTE

DURATION

 FOLLO UP

Local application

 

Arka taila

 

sufficent amount of taila(Morning and Evening)

 

bahya lepanartha (local application on affected areas)

21 days

 

6 month

 

Shaman Aushadh

 

Navkarshika kwatha

 

Twice a day

10 to 20ml

(Morning and 

Evenin)(before meal)

oral

 

21 days

 

6 month

 































 
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