| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm | Drug | Classical | | (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.
|