Development of an effective personalized treatment algorithm for management of Rheumatoid Arthritis patients and its role in gut microbiota.

Effect of Ayurveda Treatment Algorithm in the management of Rheumatoid Arthritis and its influence in Gut Microbiota

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051552

Enrollment

Registered

2023-04-12

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of age group 20â??60 years irrespective of gender. 2. The patient having the clinical features of Amavata according to Ayurvedic classics 3. Patients who fulfill ACR criteria. 4. Patients of RA having chronicity 5. Patients who are eligible for Panchakarma procedures

Exclusion criteria

Exclusion criteria: 1.Patients having severe crippling deformities 2. Patients suffering from paralysis 3. Diagnosed cases of neoplasm of spine, gout, traumatic arthritis, and pyogenic osteomyelitis 4. Patients diagnosed with associated cardiac disease, pulmonary tuberculosis, diabetes mellitus, inflammatory bowel disease, malignant hypertension, renal function impairment. 5. Recent use of antibiotic therapy ( 6. Pregnant women and lactating mother

Design outcomes

Primary

Measure	Time frame
â?¢Effect of an Ayurveda treatment algorithm in the clinical outcomes of Rheumatoid Arthritis patients. â?¢Effect of an Ayurveda treatment algorithm in gut microbiome of Rheumatoid Arthritis patients Timepoint: Base line (BT) 0th day After treatment (AT)- 34rd day or till the attainment of full course of treatment After Follow up (AF)-68th day or the double number of days from the baseline	—

Secondary

Measure	Time frame
OBJECTIVE PARAMETERS: i.Clinical signs and symptoms will be assessed by Clinical Disease Activity Index (CDAI) The CDAI includes Tender joint count of 28 joints (28TJC), Swollen joint count of 28 joints (28SJC), Patient global assessment (PtGA) of disease activity on visual analogue scale (0â??10) and Physician global assessment (PhGA) of disease activity on visual analogue scale (0â??10). ii.Activities of patient will be assessed by Patient Activity Scale (PAS) PAS includes Health Assessment Questionnaire, Pain Visual Analog Scale and Patient Global Assessment of Disease Activity iii.Activity of disease will be assessed by Disease Activity Scale (DAS28) Disease Activity Score in 28 Joints (DAS28) scoring in rheumatoid arthritis (RA) includes number of tender and swollen joints, the patientâ??s assessment of their disease activity and its impact on their overall health (using a VAS) and their ESR. iv.ACR/EULAR criteria v.Gut microbiome analysis Timepoint: Base line (BT) 0th day After treatment (AT)- 34rd day or till the attainment of full course of treatment After Follow up (AF)-68th day or the double number of days from the baseline	—

Measure

Time frame

OBJECTIVE PARAMETERS: i.Clinical signs and symptoms will be assessed by Clinical Disease Activity Index (CDAI) The CDAI includes Tender joint count of 28 joints (28TJC), Swollen joint count of 28 joints (28SJC), Patient global assessment (PtGA) of disease activity on visual analogue scale (0â??10) and Physician global assessment (PhGA) of disease activity on visual analogue scale (0â??10). ii.Activities of patient will be assessed by Patient Activity Scale (PAS) PAS includes Health Assessment Questionnaire, Pain Visual Analog Scale and Patient Global Assessment of Disease Activity iii.Activity of disease will be assessed by Disease Activity Scale (DAS28) Disease Activity Score in 28 Joints (DAS28) scoring in rheumatoid arthritis (RA) includes number of tender and swollen joints, the patientâ??s assessment of their disease activity and its impact on their overall health (using a VAS) and their ESR. iv.ACR/EULAR criteria v.Gut microbiome analysis Timepoint: Base line (BT) 0th day After treatment (AT)- 34rd day or till the attainment of full course of treatment After Follow up (AF)-68th day or the double number of days from the baseline

—

Countries

India

Contacts

Public ContactDr Prasanth Dharmarajan

All India Institute of Ayurveda

drprasanthd@gmail.com9895174060

Outcome results