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CTRI Number  CTRI/2025/03/081981 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 03/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Radomized controlled clinical study of shashilekhadi yoga in vicharchika  
Scientific Title of Study   A randomized controlled clinical study to evaluate the efficacy of Shashilekhadi yoga in the management of Vicharchika with special reference 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 Tejaswini Bhikaji Patil 
Designation  PG student 
Affiliation  R.A.Podar Medical College  
Address  Kayachikitsa department, R.A.Podar medical college M.A. Podar Hospital, Annnie Besant Road , worli mumbai

Mumbai
MAHARASHTRA
400018
India 
Phone  8308509382  
Fax    
Email  tejaswinipatil9382@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MEENAKSHI SUBHASH REWDKAR KOLE 
Designation  Associate professor 
Affiliation  R.A.Podar Medical College  
Address  Kayachikitsa department, R.A.Podar college (ayu ) , M.A. Podar Hospital, Annnie Besant Road , worli mumbai
Kayachikitsa department, R.A.Podar college (ayu ) , M.A. Podar Hospital, worli ,mumbai
Mumbai
MAHARASHTRA
400018
India 
Phone  9757476325  
Fax    
Email  drmrevadkar@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr MEENAKSHI SUBHASH REWDKAR KOLE 
Designation  Associate professor 
Affiliation  R.A.Podar Medical College  
Address  Kayachikitsa department, R.A.Podar college (ayu ) , M.A. Podar Hospital, Annnie Besant Road , worli mumbai

Mumbai
MAHARASHTRA
400018
India 
Phone  9757476325  
Fax    
Email  drmrevadkar@yahoo.com  
 
Source of Monetary or Material Support  
Opd No 18, Kayachikitsa Department M.A.Podar Ayurved Hospital,Worli ,Mumbai PIN code -400018 Country -India  
 
Primary Sponsor  
Name  R A Podar Govt Ayu CollegeWorliMumbai 
Address  R A Podar Govt (Ayu) College,Worli,Mumbai-18 Dr.Anie Besant Road PIN code-400018  
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 Tejaswini Bhikaji Patil  M.A.Podar Hospital, Worli , Mumbai.  OPD NO. 18,19Kayachikitsa department, R.A.Podar college (ayu ) , M.A. Podar Hospital, Annnie Besant Road , worli mumbai
Mumbai
MAHARASHTRA 
8308509382

tejaswinipatil9382@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BORS Committee of institution, R A Podar Govt Ayu college,Worli  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L208||Other atopic dermatitis. Ayurveda Condition: VICARCIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Shashilekhadi yoga, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: Khadiradi yoga, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age -18 to 60 years.
2) Sex - Both Gender
3) Patient with sign and symptoms of Vicharchika like Kandu, Pidika, Vaivarnya
and Srava.
4) Understanding and being willing to sign the informed consent form.
 
 
ExclusionCriteria 
Details  1. Pregnancy and lactating women.
2. Dry Eczema.
3. Immuno-compromised patients like AIDS (HIV positive), HbsAg positive etc.
4. Person With Severe Disorder Like CA, liver disorder, renal or cardiac
problems, bed ridden due to chronic illness, patient having uncontrolled
DM/HTN.
5. Any complication arising during the treatment of any patient discontinuing
the treatment will be excluded.
6. Patient with other debilitating disease like TB/SLE.
7. Patient on medication as, Chemotherapy or Radiotherapy.
8. Clinical H/O Chronic or acute gastritis / Colitis / BS.
9. Mentally retarded patient and psychologically disturbed.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the role of Shashilekhadi yoga in reducing kandu, pidika,
vaivarnya and srava in Vicharchika.
2) To study the role of Shashilekhadi yoga in reducing area of lesion in
Vicharchika.  
Follow up assessment of the patient every week for 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
1.To review ayurvedic and modern literature on vicharchika , eczema
2.To asses possible mode of action of Shashilekhadi yoga in vicharchika . 
At 1st , 2nd, 3rd and 4th week. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 
Date of First Enrollment (India)   20/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/03/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
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   Skin is the first organ of the body interacting with the environmental agents like biological,
physical, chemical agents. Skin helps in diagnosis of various diseases as it reflects internal and external pathology. In 21st century, continuous changing lifestyle, environment and dietary
habits have made man a main victim of many diseases. Prevalence studies have
demonstrated that between 20-30% of the population have various skin problems requiring attention.
In Ayurveda, all skin diseases are described under the heading of Kushtha. Further it is divided into Mahakushtha and Kshudra kushtha. Vicharchika is one of the kshudra kushtha.
According to the Ayurvedic texts, all types of kushtha have been considered as Tridoshaja and Raktapradoshaja Vikara. Vicharchika is also Tridoshaja and Raktapradoshaja but Acharya  explained the Dosha dominancy. Charakacharya explained Kapha dominancy
, Sushrutacharya explained Pitta dominancy. In Madhukosha commentary on Madhavanidana Lakshana of Vicharchika according to dosha is explained.
A similar clinical presentation in modern dermatology is seen in Eczema. It is a medical condition in which patches of skin become rough and inflamed with blisters which cause itching and bleeding. India records more than 10 million cases of Eczema every year, with a
prevalence rate of about 9.1%.
Vicharchika is Kapha dominant Vyadhi. Kaphghna, Ruksha, Kledaghna, Raktashodhaka, treatment is expected. SHASHILEKHADI YOGA containing the Ayurvedic dravyas which are Tikta, Katu rasatmaka, Dipana, Kushtaghna, Kandughna. Shashilekhadi yoga is acting against
the Dosha Dushya Sammurchhana in Vicharchika.
In Khadiradi yoga, Khadir has tikta-kashay rasa and laghu, ruksha guna which act as kapha and pitta shamak, Krimighna, Kledaghna. Nimba has tikta rasa which work on raktavaha strotas. Yakrut and pleeha are moolsthan of raktavaha strotas so it has yakritgamitva effect
which is important for samprapti bhanga of Kushtha (Vicharchika). Kutaki has bhedaniya karma because of its tikta rasa which helps in eliminating the factors responsible for samprapti. Shirish
is having raktashuddhikar (detoxifying) properties. In this way, khadiradi yoga shows kledaghna, kaphaghna, kushthaghna and raktashuddhikar properties.
Taking all above consideration in mind, I have selected my synopsis under the title
A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHASHILEKHADI YOGA IN THE MANAGEMENT OF VICHARCHIKA WITH SPECIAL
REFERENCE TO ECZEMA.

Alternative Hypothesis: -
Shashilekhadi yoga is effective in the management of Vicharchika with special reference to Eczema.

Null Hypothesis: -

Shashilekhadi yoga is not effective in the management of Vicharchika with special reference to Eczema. 
AIM:-
To evaluate the efficacy of Shashilekhadi Yoga in the management of
Vicharchika with Special Reference to Eczema.
OBJECTIVES:-
1. OBJECTIVES-
1) To study the role of Shashilekhadi yoga in reducing kandu, pidika,
vaivarnya and srava in Vicharchika.
2) To study the role of Shashilekhadi yoga in reducing area of lesion in
Vicharchika. 
Type of study - Open randomized controlled clinical prospective study Medium of dissertation English language, which will be supported by Ayurvedic
terminology i.e., in Sanskrit whenever necessary.
Consent -An informed written consent of all patient included in the trial in the language best understood by them will be taken.
Subject Recruitment - Patient will be selected from respective research centre.
Research centre OPD & IPD of respective research centre. 
Shashilekhadi Yoga , Khadiradi Yoga
10 gm at morning (empty stomach) 10 gm at morning (empty
stomach) will be given will be given
Follow-up assessment of the patient every week for 4 weeks
Clinical assessment of symptoms like Kandu, Srava, Pidika, Vaivarnya
will be done at the end of study
Final assessment at the end of treatment.
 
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