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
|
|
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
|
|
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. |