FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/062343 [Registered on: 06/02/2024] Trial Registered Prospectively
Last Modified On: 19/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to evaluate the efficacy of Asthapan Basti, Indrayava Kwatha and Indrayava Tailam in the management of Ek Kushtha W.S.R. to Psoriasis 
Scientific Title of Study   In disease Ek Kustha we will find out the results 0f Asthapan Basrti as Pradhan Karma, Indrayava Kwath as oral administration and Indrayava Tailam for local application. 
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 Ashish Mandloi 
Designation  P G Scholar  
Affiliation  Pandit Khushilal Sharma Government Ayurveda College and Institute Bhopal 
Address  PG Department of Panchakarma, Pt Khushilal Sharma Government Ayurveda College and Institute Science Hills Nehru Nagar Bhopal
PG Department of Panchakrma, Pt Khushilal Sharma Government Ayurveda College and Institute Science Hills Nehru Nagar Bhopal
Bhopal
MADHYA PRADESH
462003
India 
Phone  9111142251  
Fax    
Email  ashishmandlloi14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kamini Soni 
Designation  Associate Professor 
Affiliation  Pandit Khushilal Sharma Government Ayurveda College and Institute Bhopal 
Address  PG Department of Panchakarma, Pt Khushilal Sharma Government Ayurveda College and Institute Science Hills Nehru Nagar Bhopal
PG Department of Panchakarma, Pt Khushilal Sharma Government Ayurveda College and Institute Science Hills Nehru Nagar Bhopal
Bhopal
MADHYA PRADESH
462003
India 
Phone  8770037353  
Fax    
Email  skamini382@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr AshishMandloi 
Designation  PG Scholar 
Affiliation  Pandit Khushilal Sharma Government Ayurveda College and Institute Bhopal 
Address  PG Department of Panchakarma, Pt Khushilal Sharma Government Ayurveda College and Institute Science Hills Nehru Nagar Bhopal
PG Department of Panchakarma,Pt Khushilal Sharma Government Ayurveda College and Institute Science Hills Nehru Nagar Bhopal
Bhopal
MADHYA PRADESH
462003
India 
Phone  9111142251  
Fax    
Email  ashishmandloi14@gmail.com  
 
Source of Monetary or Material Support  
PG Department of Panchakarma Pt Khushilal Sharma Govt. Ayurveda College And Institute Bhopal 
 
Primary Sponsor  
Name  Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal (MP) 
Address  Pt Khushilal Sharma Government (Autonomous) Ayurveda college and Institute Science Hills Nehru Nagar Bhopal 
Type of Sponsor  Government funding agency 
 
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 Ashish Mandloi  Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal (MP)  PG Department of Panchakarma, Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Science Hills Nehru Nagar Kolar bypass Bhopal (MP)
Bhopal
MADHYA PRADESH 		 9111142251

ashishmandloi14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), Pt Khushilal Sharma Govt Autonomous Ayurveda College and 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: Indrayava Kwatha, Reference: Bhavprakasha Nighantu Haritakyadi Varga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -Indrayava Tailam for Local application
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Cgarak Chikitsa 7, Procedure details: Basti Plan with Asthapan Basti with Daruharidradi Kashaya & Anuvasana Basti Til Tail for 16 days in 3:1 Manner)
(1) Medicine Name: Indrayava Kwatha, Reference: Bhavaprakasha Nighantu Haritakyadi Varga, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 21 Days
(2) Medicine Name: Indrayava Tail, Reference: Bhavaprakasha Nighantu, Haritakyadi Varga, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: bd, Duration: 21 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient of both the sex between 21 to 60 year of age.
Patient fulfilling the diagnostic criteria of Ek kushtha.
Willing to sign the written consent for participation in study.
Patient fit for Asthapan Basti karma.
 
 
ExclusionCriteria 
Details  Patient with other chronic symptoms disease like Diabetes Mellites, Ischemic heart disease, Anemia, Tuberculosis, Malignancy, etc. were be excluded.
Pregnant and Lactating womans were not included in the study.
Patients associated with other skin disorder were also excluded.
Patients below 21 years and above 60 years.
Patients contraindicated for Asthapan Basti Karma.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
It is expected that at the end of the study we might be able to demonstrate the effect of Asthapan Basti along with Indrayava Kwatha and Indrayava Tailam in the management of Ek Kushtha as a result patient get relief in itching, scaling etc previously complaints in 21 days.   21 days  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/03/2024 
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  

It is expected that at the end of the study we might be able to demonstrate the effect of Asthapan Basti along with Indrayava Kwatha and Indrayava Tailam in the management of Ek Kushtha.

 
Close