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CTRI Number  CTRI/2025/05/086168 [Registered on: 02/05/2025] Trial Registered Prospectively
Last Modified On: 01/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative evaluation of effectiveness of ‘ Arka Taila’ verses Clobetasol Propionate cream on Vicharchika with special reference to Eczema… A Randomised clinical Trial. 
Scientific Title of Study   An Open Randamised Controlled Clinical study to compare and evaluate the effectiveness of ‘ Arka Taila’ verses Clobetasol Propionate cream on 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 Shaista Mohd Shakeel Mansuri 
Designation  PG scholar  
Affiliation  R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18 
Address  OPD NO. 15 Agadtantra Department,M.A.Podar Hospital,R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18

Mumbai
MAHARASHTRA
400018
India 
Phone  9321731121  
Fax    
Email  uniqueshai9321@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Savita C Samleti  
Designation  Assistant professor  
Affiliation  R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18 
Address  OPD NO. 15 Agadtantra Department,M.A.Podar Hospital,R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18

Mumbai
MAHARASHTRA
400018
India 
Phone  9820366734  
Fax    
Email  Savita_g123@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Savita C Samleti  
Designation  Assistant professor  
Affiliation  R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18 
Address  OPD NO. 15 Agadtantra Department,M.A.Podar Hospital,R.A.Podar Govt(Ayu) collage,Worli,Mumbai-18

Mumbai
MAHARASHTRA
400018
India 
Phone  9820366734  
Fax    
Email  Savita_g123@yahoo.co.in  
 
Source of Monetary or Material Support  
OPD No. 15 Agadtantra, Department,M.A.Podar Hospital,R.A.Podar Govt(Ayu) collage,Worli,Mumbai 400018 
 
Primary Sponsor  
Name  R A Podar Govt (Ayu) Collage,Worli,Mumbai-18 
Address  R A Podar Govt (Ayu) Collage,Worli,Mumbai-18 Dr.Annie 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 Shaista Mohd Shakeel Mansuri   Mahadevi Anandilal Podar Govt Hospital   OPD No.15, Agadtantra Department,R.A.Podar Govt(Ayu) collage,Worli ,Dr Annie Besant Road, Pin code-400018
Mumbai
MAHARASHTRA 		 9321731121

uniqueshai9321@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:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Clobetasol propionate cream The clobetasol propionate cream is a steroidal ointment used for many skin diseases.
2Intervention ArmDrugClassical(1) Medicine Name: Arka tail , Reference: Sharangdhar samhita, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient with sign and symptoms of Vicharchika like Kandu, pidika , shyavavarna and ,
bahustrava all over body.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 deliberating disease like TB/SLE.
7.Patient on medication as, Chemotherapy or Radiotherapy.
8. Patient which uses other ointment or local application.
9.Mentally retarded patient and psychologically disturbed. 
 
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 
to evaluate subject for subjective symptoms like pidika,shyavavarnata, bahustrava and kandu and objective assessment for reducing the area of lesions in group of arka taila.
To evaluate subject subjective symptoms like pidikal, shyavarna, bahustrava and kandu and objective assessment for reducing the area of lesion in group of clobetasol propionate cream.
To compare the subjective symptoms like pidika, shyavarna, bahustrava and kandu and objective assessment for reducing the area of lesion between the two groups  		 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
1. to assess the possidble mode of action of arka tail.
2. To reduce the use of steroidal ointments. 		 1 month 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   16/05/2025 
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="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  
INTRODUCTION:
Ayurveda is one of the ancient health care system. Ayurveda promotes specific lifestyle changes and natural treatments to restore harmony between the body, mind, spirit and environment. Ayurveda is a holistic tradition and way of life that can assist each of us in claiming and celebrating our ability for wellness. One of the branch of Ayurveda, is Agadtantra . 
Agadtantra & Vishachikitsa specializes in the management and prevention of dermatological disorders. Agadtantra focuses on: Hair fall, Dandruff, Pimples, Acne, Skin conditions like dry skin, skin colour changes, itching etc, Insect bites and stings, Spider and Scorpion poisoning, Chronic snake poisoning, Acute and chronic food poisoning, Non healing ulcer with history of poisoning, Chronic and acute skin disorders with history of poisoning, Chronic or cumulative toxicity.
In Ayurveda, all skin diseases are described under the heading of Kushtha. Further it is divided into Mahakushtha and Kshudrakushtha[1] . Vicharchika is one of the kshudrakushtha.  
Vicharchika is Kapha dominant Vyadhi. Kaphghna, Ruksha, Kledaghna, Raktashodhaka, treatment is expected. Arka taila [3] described under ancient texts have Gunas which are opposite to the Vyadhi Doshas, the vitiated Doshas of Vicharchika which are described above are mostly Kaphaj and Arka taila contains Ushna and Tikshna Guna so by opposing the above Doshas the diseases are trying to be treated. 
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%.
Arka Taila contains only three drugs viz. Arka Patra (Calotropis procera), Haridra (Curcuma longa) and Sarshapa Taila(Brassica campestris). Arka Taila was prepared by general method of preparation of Taila Kalpana till the Kharapaka stage. Arka Taila has Katu and Tikta Rasa, Ruksha, Laghu, Tikshna Guna, Ushna Veerya, Katu Vipaka, and Kapha-Vatashamaka properties.

NEED OF STUDY:
India records more than 10 million cases of Eczema every year, with a prevalence rate of about 9.1%.
To reduce the prevalence of eczema (Vicharchika) .
To reduce the use of topical steroids like clobetasol propionate cream 0.5%.  
To enhance the use of ayurvedic Drugs.

NUMBER OF PATIENTS :
Group A - study group - 35 patients will apply arka taila.
Geoup B - control group - 35 patients will apply clobetasol propionate cream.

INVESTIGATION:
CBC, ESR, LFT, RFT, BSL, lipid profile, HbsAg, VDRL

SUMMARY AND CONCLUSION:
The work will be summarized to make final conclusions Observations of results will be concluded with statistical analysis under the heading ‘Conclusion’ with explanation at the end of whole research.
 
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