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CTRI Number  CTRI/2021/01/030790 [Registered on: 27/01/2021] Trial Registered Prospectively
Last Modified On: 16/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Polyherbal decoction for Psoriatic arthritis 
Scientific Title of Study   A clinical study to evaluate the effectiveness of Navakarshika kashaya in Vatarakta(Psoriatic arthritis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yogesh Kumar Pandey 
Designation  Associate Professor (Dept of Kayachikitsa) 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi

South West
DELHI
110073
India 
Phone  9013858523  
Fax    
Email  dryogeshpandey@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mansi Grewal 
Designation  MD(Ayu) Scholar (Dept of Kayachikitsa) 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi

South West
DELHI
110073
India 
Phone  9560462029  
Fax    
Email  mansimannu2910@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Yogesh Kumar Pandey 
Designation  Associate Professor (Dept of Kayachikitsa) 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi

South West
DELHI
110073
India 
Phone  9013858523  
Fax    
Email  dryogeshpandey@gmail.com  
 
Source of Monetary or Material Support  
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi 
 
Primary Sponsor  
Name  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najagfarh New Delhi 
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 Yogesh Kumar Pandey  Chaudhary Brahm Prakash Ayurved Charak Sansthan  Department of Kayachikitsa Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi
South West
DELHI 
9013858523

dryogeshpandey@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC CBPACS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L405||Arthropathic psoriasis. Ayurveda Condition: Vatarakta,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Navakarshika kashaya  Navakarshika kashaya will be provided in form of powdered raw material for the purpose of making fresh decoction. Decoction thus formed will be given in dose of 30ml twice daily, empty stomach(minimum four hours of fasting), for a period of 28 days.To ensure uniform preparation, the subjects will be supplied with packets containing crude drug dose for 7 days in one visit. Next packets will be given in subsequent visits. Labeled disposable glasses for measurement of water will be provided. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects having minimum three of the clinical features of Vatarakta as mentioned in Charak Samhita Chikitsa Sthana Vatashonita chikitsa adhyaya ruja(joint pain of varying severity), shvayathu(joint swelling), stabdhta(joint stiffness), shyavata tamrata(discoloration) and having Psoriatic arthritis as diagnosed by CASPAR criteria (Classification Criteria for Psoriatic Arthritis).

Subjects who are ready to give consent for trial with firm residential address and contact numbers.  
 
ExclusionCriteria 
Details  Subjects having no symptoms of Vatarakta as mentioned in Charak Samhita Chikitsa Sthana Vatashonita chikitsa adhyaya and not meeting CASPAR criteria (Classification Criteria for Psoriatic Arthritis).

Subjects with known other causes of inflammatory arthritis.

Subjects with pre-established co-morbid chronic illness, such as diabetes, hypertension, coronary artery disease and having any other concomitant illness that may affect the study.

Pregnant or lactating subjects.

Subjects with known hypersensitivity to contents of Navakarshika kashaya.

Subjects currently receiving any drug(s) that can influence outcome measures of study, such as DMARDs, NSAIDs, PDE4.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in DAPSA(Disease Activity index for Psoriatic Arthritis) Score  Day1, Day14, Day28 
 
Secondary Outcome  
Outcome  TimePoints 
Attainment of status of Dhatusamyata and Vikaropshama.
 
Day1, Day14, Day28 
Improvement in grade of symptom severity of Vatarakta.   Day1, Day14, Day28 
Improvement in markers of inflammation (ESR, CRP.)   Day1, Day14, Day28 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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 4 
Date of First Enrollment (India)   01/02/2021 
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   Results will be published in the peer reviewed indexed journals. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Vatarakta is an illness caused by the concurrent aggravation of both Vata and Rakta which is acts as the combination of wind and fire. Vitiated Vata and Rakta lead to the initiation and progression of a disease process that is specific to Vatarakta. As per Acharya Charaka, Vatarakta is of two types. a) Uttana  b) Gambhira. A third clinical entity, Ubhayashrita Vatarakta is also described as a condition showing features of both Uttana and Gambhira variety. Uttana Vatarakta manifests in Tvaka and Mamsa. Gambhira Vatarakta has involvement with gambhira dhatus. Psoriatic arthritis(PsA) is defined as inflammatory arthritis associated with psoriasis, usually seronegative for rheumatoid factor. Purvaroopa(prodromal features), Roopa(clinical features) and Updrava(complications and comorbidities) of Vatarakta which are seen in Psoriatic arthritis are Sandhi shaithilya(~loss of function of joints), nistoda-sphurana-bheda in hasta pada sandhi(~pain in joints of hands and feet commonly), ruka bhutva bhutva nashyati(~pain that is of relapsing-remitting nature), vaivarnya and mandalotpatti(~discoloration and skin lesions). shvayathu stabdha kathina(~hard and immobile swelling), bhrisha arti and toda(~excess pain in involved parts), daha(~burning sensation), shyava and tamrata(~discoloration), paka(~suppuration or irreversible destruction.) mamsa kotha(~pyoderma gangrenosum), sphota, pangulya, angulivakrata(~arthritis mutilans), aswapan(~loss of sleep), bhrama, klama(~ depression, anxiety), marmagraha(~rigidity of vital points around joints, improper function of vital organs)- murchha(loss of consciousness)- shwasa(~metabolic syndrome and its components, atherosclerosis, aortic insufficiency, conduction disturbances. chronic obstructive lung disease). Clinical features of vatarakta  are similar to that of psoriatic arthritis. For all practical purposes it seems that psoriatic arthritis is similar clinical entity as vatarakta

 

In allopathic sciences, psoriatic arthritis is treated based on updated EULAR recommendations. Agents used are non-steroidal anti inflammatory drugs(NSAIDS), conventional synthetic disease modifying anti rheumatic drugs (csDMARDs) , biologic disease modifying anti rheumatic drugs (bDMARDs), phosphodiaesterase 4 inhibitor. However, these treatment recommendations have side effects like upset stomach, nausea, diarrhea, hair loss, rash or skin reaction, risk of infection, malignancy due to inhibited tumor surveillance, congestive heart failure, demyelinating disease, infusion reactions and injection site reactions, gastrointestinal perforations; liver, kidney and lung disorders. Each class of agent is used for 3-6 months before assessing outcome, based on effect the drug is either continued indefinitely or patient is shifted to other class of agents. Navakarshika kashaya is a herbal formulation for treatment of vatarakta as mentioned in several ayurvedic texts. It has nine components taken in equal proportion Triphla, Nimba, Guduchi, Vacha, Manjistha, Katuki, Daruharidra. Contents of Navakarshika kashaya are easily available in local market as well as in neighbourhood of Indian population. Therefore, it is a promising, cost effective therapy without any side effects in comparison to prevalent conventional therapies. So, if this is effective in treatment of psoriatic arthritis, it will be helpful in reducing disease burden, improving health quality in psoriatic arthritis patients in a cost effective manner.

 

 
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