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CTRI Number  CTRI/2025/05/087282 [Registered on: 21/05/2025] Trial Registered Prospectively
Last Modified On: 21/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluate the efficacy of Amrutanagaradi Kwatha in the management of Eka Kushtha (Psoriasis) 
Scientific Title of Study   Randomized controlled clinical trial to evaluate the efficacy of Amrutanagaradi Kwatha in the management of Eka Kushtha (Psoriasis) 
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 Arti Sominath Maske 
Designation  Pg Scholar  
Affiliation  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra  
Address  Opd No. 13, Kayachikitsa Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Aurangabad Maharashtra 431011
Opd no.13, Kayachikitsa department,C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan road Aurangabad Maharashtra 431011
Aurangabad
MAHARASHTRA
431011
India 
Phone  9834017500  
Fax    
Email  artimaske1999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Naresh Ramrao Nimbalkar  
Designation  Associate Professor  
Affiliation  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra  
Address  OPD NO. 13, Kayachikitsa Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Aurangabad Maharashtra 431011
Opd no.13, Kayachikitsa department,C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan road Aurangabad Maharashtra 431011
Aurangabad
MAHARASHTRA
431011
India 
Phone  9422711098  
Fax    
Email  ayushakti009@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arti Sominath Maske 
Designation  Pg Scholar  
Affiliation  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad  
Address  Opd No. 13, Kayachikitsa Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Aurangabad Maharashtra 431011
Opd no.13, Kayachikitsa department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan road Aurangabad Maharashtra 431011
Aurangabad
MAHARASHTRA
431011
India 
Phone  9834017500  
Fax    
Email  artimaske1999@gmail.com  
 
Source of Monetary or Material Support  
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
 
Primary Sponsor  
Name  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
Address  OPD NO.13 Kayachikitsa Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Aurangabad Maharashtra India 431011 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrArti Sominath Maske  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011  OPD NO. 13, Kayachikitsa Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Aurangabad Maharashtra 431011
Aurangabad
MAHARASHTRA 
09834017500

artimaske1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Aurangabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: EKAKUSHTHAH, (2) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: EKAKUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Amrutanagaradi Kwatha, Reference: Sahastrayog By Dr. D.B.Panditrao pg.no.04,shloka no.16, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Sukhoshna jala), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Arogyavardhini vati, Reference: Ras ratna samuchaya of vaghbhatacharaya by Indradevi Tripathi Chaukhamba surbharti prakashan adhyaya 20, shloka no.87-90 pg.no252, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Sukhoshna jala), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1)Patients irrespective of gender and religion will be selected.
2)Patients having clinical features of Eka kushtha such as Mahavastu(Extent of lesion) and
Matsyashakalopama(Scaling),
Aswedanam(Unhydrosis),
Krushnaaruna varna(Erythema).
3)Patients showing sign and symptoms of Psoriasis less than 2 years.

 
 
ExclusionCriteria 
Details  1)Patients below 20 year and above the age 55 year of age.
2)Patients with pregnancy and lactation.
3)Patients suffering from Psoriatic arthritis, Tinea corporis, Eczema, Lichen planus, Contact dermatitis.
4)Patients on steroids for more than one year. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Matsyashakalopam (scaling),
Krushnaaruna Varna (Erythema)
This Symptoms Will Be Reduced 
45 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Mahavastu(Extent of lesion)
This Symptom Will Be Reduced  
45 Days 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   01/06/2025 
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="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  

                 In today’s fast track life style, people are shifting more toward mechanistic world and are adopting unhealthy dietary and lifestyle choices, which have resulted in increasing trend of lifestyle diseases. Psoriasis is one amongst these notorious auto-immune disorders having deep psychological and social impacts. It is a chronic inflammatory disease with skin manifestations, aggravated by or can recur by number of triggering factors such as psychological (anxiety, stress, depression etc.), dietary (incompatible diet), lifestyle disturbances, medications .

Psoriasis word derived from word ‘Psora’ which means ‘itch’ or ‘Rash’.

Psoriasis is non-infectious chronic inflammatory disease of the skin characterized by well-defined erythematous plaque with silvery scale which have predilection for extensor surfaces and scalp and by chronic fluctuating course.

Kushtha (skin disorders) has been considered among Ashtamahagada  (octa- ominous disorders) in Ayurveda. Eka Kushtha is one of the subtypes of Kushtha, which is equated with Psoriasis as they show similar manifestations such as Aswedanam (anhydrosis), Mahavastu (extent of lesion), Matsyashakalopamam (scaling).

According to many acharyas in kushta vyadhi all the three dosas involvement have been seen.

The Lakshanas of Eka Kushtha are Aswedanam ,Mahavastu (extent of lession), Mastyashakalopam ( Scaling).

                                    In india the Prevalence of Psoriasis varies From 0.44 To 2.8 %. It is  twice  more common in males compare to female and most of the patients are in there third or forth decade.

In ayurveda, many herbs have proven efficacy in psoriasis but the multifaceted etiology of disease need multimodal treatment approach.

The prevalence rate of psoriasis increasing day by day despite having such as high prevalence rate the treatment of psoriasis is still limited so the study is conducted.

In kushta, there is involvement of tridoshas and Amrutanagaradi Kashaya mentioned in Sahastrayog have great action on all tridoshas and it produces deeper action on Eka kushta .Therefore study is undertaken to evaluate the efficacy of Amrutanagaradi kwatha on Eka kushtha.

 


 
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