Polyherbal decoction for Psoriatic arthritis

Phase 4

Not yet recruiting

• Conditions: Arthropathic psoriasis. Ayurveda Condition: Vatarakta,

• Registration Number: CTRI/2021/01/030790
• Lead Sponsor: Chaudhary Brahm Prakash Ayurved Charak Sansthan

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), *Roop*a(clinical features) and *Updrava*(complications and comorbidities) of *Vatarakta* which are seen in Psoriatic arthritis are *Sandhi shaithilya(~*loss of functionof 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-02
• Last Update Posted: 2021-01-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in DAPSA(Disease Activity index for Psoriatic Arthritis) Score	Day1, Day14, Day28

Secondary Outcome Measures

Name	Time	Method
Attainment of status of Dhatusamyata and Vikaropshama.
Improvement in grade of symptom severity of Vatarakta.	Day1, Day14, Day28
Improvement in markers of inflammation (ESR, CRP.)	Day1, Day14, Day28

Trial Locations

Locations (1)

Chaudhary Brahm Prakash Ayurved Charak Sansthan; 🇮🇳 West, DELHI, India

Chaudhary Brahm Prakash Ayurved Charak Sansthan

🇮🇳West, DELHI, India

Dr Yogesh Kumar Pandey

Principal investigator

9013858523

dryogeshpandey@gmail.com