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CTRI Number  CTRI/2025/08/093010 [Registered on: 13/08/2025] Trial Registered Prospectively
Last Modified On: 12/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study conducted to see the effect of Kandwado Lepa, Rajavrukshadipachana Kashaya and Kasamarda Lepa, Nava Kashaya in the management of Itching and discoloration of skin . 
Scientific Title of Study   RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF KANDWADO LEPA AND RAJAVRUKSHADIPACHANA KASHAYA IN VICHARCHIKA. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Geeta 
Designation  M.D 2 nd year 
Affiliation  Rajarajeshwari Ayurvedic Medical college Hospital and P.G centre, Hummabad 585330, District Bidar 
Address  MIG 133 KHB colony Old Jewargi road Gulbarga 585102
Dept. Of Kayachikitsa, Room no.-03 , 1st floor , Rajarajeshwari Ayurvedic Medical college Hospital and P.G centre, Humnabad 585330, District Bidar
Bidar
KARNATAKA
585102
India 
Phone  7349160150  
Fax    
Email  geeta.npatil5578@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Geeta 
Designation  M.D 2 nd year 
Affiliation  Rajarajeshwari Ayurvedic Medical college Hospital and P.G centre, Hummabad 585330, District Bidar 
Address  MIG 133 KHB colony Old Jewargi road Gulbarga 585102
Dept. Of Kayachikitsa, Room no.:-03, 1st floor , Rajarajeshwari Ayurvedic Medical college Hospital and P.G centre, Humnabad 585330, District Bidar
Bidar
KARNATAKA
585102
India 
Phone  7349160150  
Fax    
Email  geeta.npatil5578@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K Karunakar Rao 
Designation  HOD 
Affiliation  Rajarajeshwari Ayurvedic Medical college Hospital and P.G centre, Hummabad 585330, District Bidar 
Address  Rajarajeshwari Ayurvedic Medical college Hospital and P.G centre, Humnabad 585330, District Bidar
Dept. Of Kayachikitsa, Room no. :-03 , 1st floor , Rajarajeshwari Ayurvedic Medical college Hospital and P.G centre, Humnabad 585330, District Bidar
Bidar
KARNATAKA
585330
India 
Phone  8008402007  
Fax    
Email  karunakarrao040@gmail.com   
 
Source of Monetary or Material Support  
Rajarajeshwari Ayurvedic Medical college Hospital and P.G centre, Humnabad Bidar 585330 
 
Primary Sponsor  
Name  Rajarajeshwari Ayurvedic Medical college Hospital and P. G Centre  
Address  Rajarajeshwari Ayurvedic Medical college Hospital and P.G Centre, Humnabad 585330 District- Bidar 
Type of Sponsor  Private 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 
DrGeeta  Rajarajeshwari Ayurvedic Hospital Humnabad   Dept. Of Kayachikitsa Room no.:-03 First floor Humnabad 585330
Bidar
KARNATAKA 
7349160150

geeta.npatil5578@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajarajeshwari Ayurvedic Medical college Hospital and P.G Centre college Hospital and P.G centre, Hummabad 585330, District Bidar  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: Rajavrukshadipachana Kashaya., Reference: Bharat Bhaishajya Ratnakara, Shloka no.:-5863, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Kandwado Lepa, Reference: Sharangadhara Samhita: Lepa prakarana , chapter -11, shloka no.-50 , Route: Topical, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Jala), Additional Information: -
3Comparator ArmDrugClassical(1) Medicine Name: Kasamardai Lepa , Reference: Bharat Bhaishajya Ratnakara, Shloka no - 1412, Route: Topical, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Jambira swarasa), Additional Information: -
4Comparator ArmDrugClassical(1) Medicine Name: Navakashaya , Reference: Chakradatta: Chikitsa sthana : Kushta Chikitsa Adhyaya :shloka no.-75 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -ushna jala ), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age-20 to 60 years
Sex-Both male and female
Main symptoms of Vicharchika-Kandu, Pidaka, Shyavata, Srava.
Associated symptoms-Daha, Rukshata, Shotha. 
 
ExclusionCriteria 
Details  a. Age-Below 20 and above 60 years

Pregnant and lactating Mother



Age- below 20 and above 60yrs
Pregnant and lactating mothers
Known case of tuberculosis, HIV, AIDS, Diabetes mellitus, hypertension, ischemic heart disease.
Patient having excessive purulent discharge. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF KANDWADO LEPA AND RAJAVRUKSHADIPACHANA KASHAYA IN VICHARCHIKA  7days 
 
Secondary Outcome  
Outcome  TimePoints 
:

a. To evaluate the therapeutic effect of Kandwado Lepa and Rajavrukshadipachana Kashaya in the management of Vicharchika.

b. To evaluate the therapeutic effect of Kasamardai Lepa and Navakashaya in the management of Vicharchika.

c. To evaluate the therapeutic effect of Kandwado Lepa, Rajavrukshadipachana Kashaya and Kasamardai Lepa, Navakashaya in the management of Vicharchika. 
7days 
 
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   N/A 
Date of First Enrollment (India)   25/08/2025 
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="1"
Months="6"
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   Ayurveda says "Sarvamanya Parityajya Shariramarupalayer" which means health should be maintained by leaving other materials aside. If health is not maintained properly one cannot lead a happy life.

In Ayurveda the word Twacha is derived from "Twacha Samvarne Dhatu" which means covering of body Skin is the largest organ of integumentary system, it covers an area of 1.8 square meters and serves as a protective barrier that prevent internal tissues from exposure to trauma, ultra violet radiation, temperature,toxins, etc.

Ayurveda explains Twacha is one among the Panchagnanendriya attributed with the function of sensationof touch, it is the Ashraya Sthana of Sweda and Loma, hence skin maintains the temperature regulation, electrolyte balance and hydration of skin. Since Twacha is Upadhatu of Mamsadhatu its role is to do Dharana (carrying).

Shabdakalpadruma says "Twachati Samvrunoti Medoshonita Kamiti" which means Twacha covers the underlying Rakta, Mamsa, Medodharu. Hence one of the important function of skin is to act as a strong physical barrier against microbial invasion and protect the body against mechanical, thermal, chemical, osmotic and photo damage.

There are many triggering factors like, changing lifestyle, pollution, excessive stress, irritants, allergens and use of chemical products, people are suffering from variety of skin diseases which is described under the term of Kushta Rogas, Which can cause significant impact on person’s quality of life.

The word "Kushta" means, that it comes out from the inner part to the outer part of skin and destroyes the organs of the body. Acharya Charaka has emphasized that Kushta is one among the Ashtamahagada.

According to Acharya Charaka, Kushta is divided into two categories Mahakustha(7), and Kshudra Kuatha(11). Vicharchika is one among the Kshudra Kustha, Vicharchika is Rakta Pradoshaja Vyadhi involvement of three Doshas with the predominance of Kapha Dosha

The Charaka Samhita describes Vicharchika as a skin condition, charecterised by Kandu (itching), Pidaka(popular eruption), Shyavata(black reddish discoloration) and Bahusrava(discharge). According to Shabdakalpodruma the disease which coats the skin in particular manner and causes cracking of skin of hands and feet mainly,

Though, there is no specific description about Nidana of Vicharchika but it being a type of Kshudra Kushta, the Nidana of Kushta considered as Nidana of the Vicharchika those are Viruddha Ahara, Drava, Snigdha, Guru Ahara, Panchakarma Apachara, Diwaswapna and Papakarma etc. Viruddha Aharas like Matsya and Payasa, Madhu and Sarpi, Madhu and Ushnajala, Ksheera and Lavana, Sheetajalasevana after Snehapana etc. leads to Vicharchika,

Though, there is no specific description about samprapti of Vicharchika but it being a type of Kshudra Kushta, the samprapti of Kushta considered as samprapti of the Vicharchika, such as due to the Nidana Sevana, the vitiation of Tridoshas occurs, then it produces Dhatu Shaitilyata leading to the Dooshona of Twak, Rakta, Mamsa, Lasika(ie Sapta Dravya) thus the manifestation of Vicharchika takes place

Vicharchika can be co-related to eczema, which is a form of dermatitis or chronic inflammatory condition of the skin, characterised by an itchy, reddish, gross thickening of skin (lichenification). Other features such as scaling, cracking, and swelling of the skin occures.

The reported prevalence ranged from 3.1% to 7.2% among the pediatric population upto 16 years of age. The prevalence of eczema ranged from 0.98% to 9.2%, in studies including pediatric and adult patients.

Eczema is considered as major health problem, affecting a high proportion of the population in India. Increased consciousness especially among the youth, because of their extra cautious towards the skin care, it may leads to an anxiety and affect socioeconomic status of an individual, so there is need of efforts to minimize the skin disease. Eczema can cause a heavy emotional damage and psychological distress,
these could be a burden to the patient and that may be far worse than the physical impact.

Raktadushti is the main cause of Vicharchika and Shodhana Karma helps to eliminate vitiated Doshas from its root", but people are not ready to take because of their busy schedules, work pressures and meetings etc.

Hence, an effort has been made to check the efficacy of Shamana Chikitsa in the management of Vicharchika through the present research work.

Hereby an effort shall be made to evaluate the therapeutic efficacy of interventions such as Shamana Chikitsa with Kandwado Lepa, Rajavrukshadipachana Kashaya and Kasamardadi Lepa, Navakashaya in the management of Vicharchika.

Ingredients of Kandwado Lepa are Chakramarda, Bakuchi, Sarshapa, Tila, Kushta, Haridra, Daruharidra and Musta, having a Guna of Kandugna, Kushtagna and Raktaprasadana.

Ingredients of Rajavrukshadipachana Kashaya are Rajavruksha, Ashwatha, Amruta, Nimba, Haritaki, Vasa, Khadira, Manjistha and Kanthakari, having a Guna of Tridoshahara, Kushtagna and Kandugna.

Ingredients of Kasamardai Lepa are Kasamarda and Jambira swarasa having a Guna of Kushtagna, and Kaphavatagna.

The ingredients of Navakashaya are Triphala, Patola, Rajani, Manjishta, Rohini, Vacha and Nimba, having a Guna of kapha pitta prasamana, raktaprasadaka, and kushtagna properties.

The aim of this study is to conduct a research on Vicharchika with the new Ayurvedic formulation which have not yet been explored, that could be easily available and affordable to the people.
 
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