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CTRI Number  CTRI/2023/03/050223 [Registered on: 01/03/2023] Trial Registered Prospectively
Last Modified On: 25/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   AYURVEDIC MANAGEMENT IN EKA KUSHTA (PSORIASIS) 
Scientific Title of Study   A COMPARATIVE STUDY TO EVALUATE THE EFFICACY OF KUSHTHAGNA MAHAKASHAYA AND AARAGHWADADI GANA ALONG WITH LOCAL APPLICATION OF KARANJADI TAIL IN THE MANAGEMENT OF EKA KUSHTA W.S.R TO PSORIASIS 
Trial Acronym  Interventional 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arpana Gupta 
Designation  MD Scholar Kayachikitsa Department 
Affiliation  Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, MP 
Address  Room no. 221, PG Department of Kayachikitsa,Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, MP Bhopal MADHYA PRADESH 462003 India
Room no. 221, PG Department of Kayachikitsa,Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, MP Bhopal MADHYA PRADESH 462003 India
Bhopal
MADHYA PRADESH
462003
India 
Phone  8989188213  
Fax    
Email  arpanagupta293@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arpana Gupta 
Designation  MD Scholar Kayachikitsa Department 
Affiliation  Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, MP 
Address  Room no. 221, PG Department of Kayachikitsa,Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, MP Bhopal MADHYA PRADESH 462003 India
Room no. 221, PG Department of Kayachikitsa,Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, MP Bhopal MADHYA PRADESH 462003 India
Bhopal
MADHYA PRADESH
462003
India 
Phone  8989188213  
Fax    
Email  arpanagupta293@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arpana Gupta 
Designation  MD Scholar Kayachikitsa Department 
Affiliation  Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, MP 
Address  Room no. 221, PG Department of Kayachikitsa,Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, MP Bhopal MADHYA PRADESH 462003 India
Room no. 221, PG Department of Kayachikitsa,Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, MP Bhopal MADHYA PRADESH 462003 India
Bhopal
MADHYA PRADESH
462003
India 
Phone  8989188213  
Fax    
Email  arpanagupta293@gmail.com  
 
Source of Monetary or Material Support  
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, MP 
 
Primary Sponsor  
Name  Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP 
Address  Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, MP, 462003 
Type of Sponsor  Research institution and hospital 
 
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 Swati Nagpal  Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, MP  Department of Kayachikitsa Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, MP, 462003 Bhopal MADHYA PRADESH
Bhopal
MADHYA PRADESH 		 9406970945

swalng05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Pt. Khushilal Sharma Government Ayurveda Institute, Bhopal (MP)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: EKAKUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Kushthagna Mahakashaya, Reference: Charak samhita sutra sthan chapter 4/13 (pn 81), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -ushnodak), Additional Information: -
(2) Medicine Name: Aaraghwadadi Gana, Reference: Sushrut samhita Sutra sthan chapter 38/7 (pn 183), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -ushnodak), Additional Information: -
(3) Medicine Name: Karanjadi tail, Reference: ( modified form of Karanjadi lepa) is described in Yog Ratnakar (Pn 218 /3), Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: sos, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -local application
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  58.00 Year(s)
Gender  Both 
Details  1] Patients fulfilling the signs and symptoms of Ekakushtha (Psoriasis) according to Ayurvedic and modern Literatures.
2] Patients of age group between 18 to 58 years, irrespective of sex, religion, socioeconomic status and occupation.
3] Patient willing to participate in this study. 
 
ExclusionCriteria 
Details  1] Patients below the age of 18 year and above the age of 58 years.
2] Patients with other chronic Systemic Disease like Diabetes mellitus, Ischemic heart disease, Anemia, Tuberculosis, malignancy etc.
3] Pregnant and Lactating Women.
4] Patients with other skin disease and psoriatic arthropathy.
5] Patients not willing to sign the written consent form. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
It is expected that at the end of the study we would be able to demonstrate the comparative efficacy of Kushthagna Mahakashaya and Aaraghwadadi Gana along with local application of Karanjadi tail in the management of Ekakushtha w.s.r. to Psoriasis.  It is expected that at the end of the study we would be able to demonstrate the comparative efficacy of Kushthagna Mahakashaya and Aaraghwadadi Gana along with local application of Karanjadi tail in the management of Ekakushtha w.s.r. to Psoriasis. 
 
Secondary Outcome  
Outcome  TimePoints 
Subjective parameter :
Matsyashaklopam/Scaling, Kandu/Itching, Aswednama /Anhydrosis, Vruttam/ Erythema, Krishna/ Blackish 		 3 times in 15 days interval 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   10/03/2023 
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
Modification(s)  		 not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 1. For the clinical study on Eka Kushta (psoriasis) , fulfilling the criteria of diagnosis and criteria for inclusion for the present study, irrespective of their religion, cast ,sex and socioeconomic status from OPD & IPD of Pt. Khushilal Sharma
Govt. Autonomous Ayurveda College & Institute, Bhopal (M.P.)
2. Study design-This study will be designed as a single blind randomized control clinical trial and the samples will be selected from simple random sampling technique.
3. Grouping- 45 patients of either sex will be randomly selected and divided into 3 groups having 15 patients in each group,
GROUP A – 15 patients of this group will be given Kushthagna Mahakashaya ghanvati and local application of Karanjadi tail
GROUP B – 15 patients of this group will be given Aaraghwadadi ghanvati and local application of Karanjadi tail
Group C- 15 patients of this group will be given placebo
4. INCLUSION CRITERIA:
1] Patients fulfilling the signs and symptoms of Ekakushtha (Psoriasis) according to Ayurvedic and modern Literatures.
2] Patients of age group between 18 to 58 years, irrespective of sex, religion, socioeconomic status and occupation.
3] Patient willing to participate in this study.
5. EXCLUSION CRITERIA:
1] Patients below the age of 18 year and above the age of 58 years.
2] Patients with other chronic Systemic Disease like Diabetes mellitus, Ischemic heart disease, Anemia, Tuberculosis, malignancy etc.
3] Pregnant and Lactating Women.
4] Patients with other skin disease and psoriatic arthropathy.
5] Patients not willing to sign the written consent form.
6. Study duration- 45 days
7. Follow up period-3 times in 15 days interval.
8.The assessment of the result will be done on detailed Proforma adapting standard methods of scoring of subjective parameter and will be statistically analysed by using suitable and appropriate test and other tests will be adopted as per the requirement.
 
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