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CTRI Number  CTRI/2025/01/079511 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 25/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Therapeutic Clinical]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Khadirashtaka kwatha and Brihat manjishtadi kwatha in the management of Ekakushta(Plaque psoriasis) 
Scientific Title of Study   Randomized Comparative study to evaluate the efficacy of Khadirashtak kwatha and Brihat manjishtadi kwath in Ekakushta w s r Plaque 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 Megha K 
Designation  PG Scholar  
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar 
Address  First floor Room no 108 Department of Kayachikitsa Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar Southwest Delhi India

South West
DELHI
110073
India 
Phone  9400145418  
Fax    
Email  meghababu48@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Atal Bihari Trivedi 
Designation  Associate Professor 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  PG Department of Kayachikitsa,Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Southwest DELHI 110073 India

South West
DELHI
110073
India 
Phone  9958046550  
Fax    
Email  abdratal8@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Atal Bihari Trivedi 
Designation  Associate Professor 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  PG Department of Kayachikitsa,Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Southwest DELHI 110073 India

South West
DELHI
110073
India 
Phone  9958046550  
Fax    
Email  abdratal8@gmail.com  
 
Source of Monetary or Material Support  
Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar Southwest Delhi India 110073 
 
Primary Sponsor  
Name  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Khera Dabar,Delhi-110073 
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 Megha K  Chaudhary Brahm Prakash Ayurved Charak Sansthan  PG Department of Kayachikitsa,Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar South West Delhi
South West
DELHI 
9400145418

meghababu48@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chaudhary Brahm Prakash Ayurved Charak Sansthan Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: EKAKUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Khadirashtaka Kwatha, Reference: Yogaratnakara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushnambu), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Brihat Manjishtadi Kwatha, Reference: Sarngdhara Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -pippali guggulu), Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patient showing sign and symptoms of Ekakushtha as mentioned in Charak Samhita

2 Patient within the age group of 21-60 years

3 Disease duration more than 1year and less than 5years

4 Patients not taking corticosteroids since last one month
 
 
ExclusionCriteria 
Details  1 Patients of Diabetes mellitus, Thyroid disorder, tuberculosis, carcinoma, other life-threatening and complicated disease and major systemic illnesses

2 Severe condition of Psoriasis like Psoriatic arthritis

3 Disease duration less than 1year and more than 5years

4 Patients on treatment with any conventional oral medicines for last one month

5 Pregnant & lactating mother

6 Age below 21 and above 60 years

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in symptom severity of Ekakushtha  30days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Psoriasis Area and Severity Index (PASI)Score

Improvement in values of CBC, ESR

 
30days 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   05/02/2025 
Date of Study Completion (India) 24/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Ekakushta is one among eleven varieties of kshudrakusthas described in Ayurvedic classics. lt is characterized by Aswedanam (Anhydrotic/hypohydratic lesions), Mahavastu (covering of large surface area), Matsyashakalopamam(scaly lesions), Twacha which bears a greater resemblance with the symptoms of plaque psoriasis.

 According to Charaka, the type of Kushtha which does not sweat, extensively spreads and resemble in the form of fish scale is known as Ekakustha. Ekakustha is Raktapradosaj vikara. The Doshadhikya of this disease is Vata-Kaphapradhan

It is described as one of the chronic disorders (Dirgha-Roga) by Acharya Charaka.According to Sushruta it is the type of Kshudrakushta in which the entire body become blackished.

Psoriasis is a common papulo-squamous disorder affecting 2% of the population and is characterized by well demarcated, red, scaly plaques. The skin becomes inflamed and hyper proliferates at about ten times the normal rate. It affects males and females equally and can involve all races. Psoriasis is T-lymphocyte-driven disorder that is a response to unidentified antigen. Un-identified triggers or infective agents like bacteria, HIV, drugs induce antigens which are presented to T lymphocytes by Langerhans cells of skin leading to a T cell activation activated cytokines that promote dermal inflammation and result into hyper-proliferation of epidermis.

                      Different patterns of psoriasis are recognized and can occur together, Certain drugs can make psoriasis worse; notably lithium, antimalarials and beta-blockers. Chronic plaque psoriasis is the most common type of psoriasis. It is characterized by pink-red, well demarcated plaques, with a silver scale seen especially on extensor surfaces of the knees and elbows.


Psoriasis is considered as a type of Kushta and may be correlated as Ekakushtha due to resemblance of signs and symptoms. In which both genetic and environmental influences have a critical role. The most characteristic lesions consist of red, scaly, sharply demarcated, and present particularly over extensor surfaces and scalp. There are many treatments available but because of its chronic recurrent nature psoriasis is a challenge to treat "Kustha is described as one of the most chronic disorders (Dirgha-Roga) by Acharya Charaka

GroupA-Khadirashtaka kwatha will be administered at the dosage of 40ml twice daily with lukewarm water one hour before meals.

Group B-Brihat Manjishtadi Kwatha will be administered at the dosage of 40ml twice daily with pippali and guggulu one hour before meals.

The study design is single-centred,open label,randomized,comparative,interventional study







 

 
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