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Effect of niruha vasthi (medicated enema) on gut microbiota in rheumatoid arthritis patients

Effect of Niruha Vasthi (medicated enema) on Prevotella species of gut microbiota in Rheumatoid Arthritis patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023644
Enrollment
10
Registered
2020-02-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Health Condition 1: M058- Other rheumatoid arthritis with rheumatoid factor

Interventions

Intervention1: Niruha Vasthi (medicated enema): Kshara Vasthi of 600 ml daily for 8 days per rectally Control Intervention1: Not applicable: Not Applicable

Sponsors

Aswathy Y S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of age group 20â??45 years irrespective of gender. 2. The patient having the clinical features of Amavata according to Ayurvedic classics 3. Patient who fulfil ACR criteria. 4. Patients identified with presence of Prevotella copri and Prevotella histicola from their fecal samples. 5. Patient of RA having chronicity 6. Patients who are eligible for Vasthi

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

MeasureTime frame
Subjective parameters 1. Clinical signs and symptoms will be assessed by Clinical Disease Activity Index (CDAI) 2. Activities of patient will be assessed by Patient Activity Scale (PAS) 3. Activity of disease will be assessed by Disease Activity Scale (DAS28) Objective parameters: 1. ACR/EULAR criteria 2. Isolation and identification of Prevotella copri and Prevotella histicola from Human Faecal microbes on 9th and 25th day of treatment. Timepoint: On 9th and 25th day of treatment.

Secondary

MeasureTime frame
Not applicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactDr Anandaraman P V

Amrita School of Ayurveda Amritapuri Amrita Vishwa Vidyapeetham India

dr.ananthramsharma@gmail.com9495130595

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026