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CTRI Number  CTRI/2024/11/076740 [Registered on: 13/11/2024] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect Of Abhaya Arishtadi Ghana Vati in Psoriasis. 
Scientific Title of Study   Randomized Clinical Trial On Effect Of Abhaya Arishtadi Ghana Vati In The Management Of 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 Dhara Deliwala 
Designation  PhD Scholar  
Affiliation  G J Patel Institute of Ayurveda Studies and Research Center 
Address  Department of Kayachikitsa, G J Patel Institute of Ayurveda Studies and Research Center, New Vallabh Vidyanagar, Anand

Anand
GUJARAT
388121
India 
Phone  9426712776  
Fax    
Email  drdhara.deliwala@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yogesh Deole 
Designation  Professor  
Affiliation  G J Patel Institute of Ayurveda Studies and Research Center 
Address  Department of Kayachikitsa, G J Patel Institute of Ayurveda Studies and Research Center, New Vallabh Vidyanagar, Anand

Anand
GUJARAT
388121
India 
Phone  9974999309  
Fax    
Email  yogesh.deole@cvmu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Dhara Deliwala 
Designation  PhD Scholar 
Affiliation  G J Patel Institute of Ayurveda Studies and Research Center 
Address  Department of Kayachikitsa, G J Patel Institute of Ayurveda Studies and Research Center, New Vallabh Vidyanagar, Anand

Anand
GUJARAT
388121
India 
Phone  9426712776  
Fax    
Email  drdhara.deliwala@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  G J Patel Institute of Ayurveda Studies and Research Center 
Address  G J Patel Institute of Ayurveda Studies and Research Center, New Vallabh Vidyanagar, Anand, Gujarat- 388121 
Type of Sponsor  Private 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 Dhara Deliwala   Shri V M Mehta Institute of Ayurveda  Department of Kayachikitsa, Shri V M Mehta Institute of Ayurveda, Rajkot- Kalawad Highway, Village: Anandpar Rajkot - 361162
Rajkot
GUJARAT 
9426712776

drdhara.deliwala@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
INSTITUTIONAL HUMAN 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: Abhaya Arishtadi Ghana Vati , Reference: Chakradatta Kushtha Chikitsa/64, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Normal water), Additional Information: for local application Bruhath Danthapala tail will be given
2Comparator ArmDrugClassical(1) Medicine Name: Kaishore Guggulu , Reference: Sharangadhara Samhita, Madhyama khanda, chapter no. 7- verse 70-81, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Manjishthadi kwatha), Additional Information: Kaishore Guggulu will be given with 40ml Manjishthadi Kwatha both the time - for local application like interventional group the local application of Bruhath Danthapala Taila will be given
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient who fulfills the diagnostic criteria of psoriasis.
2. Patient who has chronicity of less than 5 years will be taken.
3. PASI score – 0-10 will be taken. 
 
ExclusionCriteria 
Details  1. Pregnant and lactating women.
2. Patients with any other skin diseases.
3. Patients with associated diseases like cardiovascular disorders, hyperthyroidism or
hypothyroidism, cancer, tuberculosis, heart diseases, psoriatic arthritis, and kidney and
liver disorders.
4. Patients who have taken medication of corticosteroids or drugs within the last 3 months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in the subjective and objective criteria of psoriasis with intervention of Abhaya Arishtadi Ghana Vati.
 
7th,14th,21st,30th days 
 
Secondary Outcome  
Outcome  TimePoints 
To explore the etio-pathological role of dietary factor in psoriasis.
 
1month 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/01/2025 
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   Psoriasis, often equated with Ekakushtha in Ayurveda, is a chronic, immune-mediated skin disorder that significantly impacts the quality of life of affected individuals. 
Despite advancements in modern dermatology, the management of psoriasis remains challenging due to its recurrent nature, potential side effects of long-term allopathic treatments, and the lack of a definitive cure. This has led to an increasing interest in exploring alternative and complementary therapies, particularly those rooted in traditional systems of medicine like Ayurveda. 
In recent years, there has been a growing recognition of the potential benefits of Ayurvedic treatments in managing chronic conditions like psoriasis.
Formulations such as Abhaya Arishtadi Ghana Vati have been traditionally used in Ayurveda to treat kushtha due to their properties in balancing doshas, enhancing digestion, and detoxifying the body. 
However, there is a paucity of rigorous clinical research validating these formulations’ efficacy in managing psoriasis, particularly in the context of randomized clinical trials.
The study will utilize randomization to allocate patients into two groups: an interventional group and a comparator group. In the interventional group, patients will receive Abhaya Arishtadi Ghana Vati at a dose of 3 tablets twice daily, combined with the topical application of Bruhath Danthapala Taila. In the comparator group, patients will be administered Kaishore Guggulu (3 tablets twice daily) alongside Manjishthadi Kwatha (40 ml twice daily) with the same topical application of Bruhath Danthapala Taila. Prior to treatment in both groups, Koshthashuddhi (bowel cleansing) will be performed using Triphala Kwatha and Eranda Taila. Patients will also be advised to follow a specific pathya ahara (wholesome diet) throughout the one-month treatment period.

 
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