Correlation between Jivha Samata (coated tongue) and Disease Activity in cases of Amavata (Rheumatoid Arthritis): a Cross-sectional Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Correlation between Coating (Samata) of tongue and Clinical Disease Activity Index in patients with Rheumatoid Arthritis (Amavata)
Study Overview
Brief Summary
Tongue examination is described in Ayurveda (eight-fold examination of patient) as well as Unani, Siddha, Korean, Greek, and Traditional Chinese Medicine. Clinicians of Ayurveda often examine jivha-samata (tongue-coating) in ama-related conditions. Severity of tongue-coating can be clinically assessed by Winkel tongue coating index (WTCI) using analysis of smart-phone images by experienced clinicians. An observational study is planned to study the association of tongue-coating and disease severity (assessed by Clinical Disease Activity Index – CDAI) as well as the severity of ama evaluated by validated ama-instrument in patients with Rheumatoid arthritis (RA) as a prototype of amavata.
Primary Objective
To study the correlation between sam-jivha (WTCI) and CDAI in the patients of amavata (RA) with the help of analysis of smartphone-captured photographs of the tongue.
Secondary Objectives
1. To evaluate the relation between the ama instrument and severity of sam-jivha (WTCI) in the patients with amavata (RA)
2. To identify inter-rater reliability in the assessment of sam-jivha (WTCI) in the patients with amavata (RA).
Materials: Consecutive out-patients suffering from RA divided in two groups: Treatment naïve patients with active RA, and patients of RA in remission as defined by CDAI (less than 2.8) (15 subjects in each group)
Place of study: Lupus Clinic, Tilak Road, Pune 411002
Methods: Subjects of RA diagnosed as per ACR/EULAR criteria (2010) will be assessed for disease activity (CDAI), and severity of ama assessed by validated ama-instrument. A photograph of tongue obtained by smartphone using standard procedure will be assessed by at least three expert clinicians for WTCI. The data will be analyzed and interpreted for drawing conclusions. The conclusions will be disseminated in appropriate publications.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Group A: 1.Patients who fulfil ACR/EULAR 2010 criteria for diagnosis of RA 2.Age above 18 years 3.Patients who sign the informed consent form Group B: 1.Patients of RA who are in remission (CDAI less than 2.8) 2.Age above 18 years 3.Patients who sign the informed consent form.
Exclusion Criteria
- •Pregnancy
- •Post-partum period (up to nine months)
- •Joint pain and swelling following trauma
- •Patients with fever (axillary temperature more than 99 degrees F)
- •Neurological disorders that limit mobility e.
- •g., hemiplegia, paraplegia, Parkinsonism, lumbar canal stenosis
- •History of endocrine disorders e.g., diabetes mellitus, hypothyroidism
- •History of chronic gastrointestinal disorder e.g., GERD, inflammatory bowel disease
- •Use of drugs Group A: I) Long-acting glucocorticoids or disease modifying antirheumatic drugs during previous three months ii) Nonsteroidal anti-inflammatory drugs or glucocorticoids within previous 24 hours of examination Group B: I.
- •Nonsteroidal anti-inflammatory drugs or glucocorticoids within previous 24 hours of examination.
Outcomes
Primary Outcomes
Correlation between Coating (Samata) of tongue and Clinical Disease Activity Index in patients with Rheumatoid Arthritis (Amavata)
Time Frame: Single patient visit (cross-sectional study)
Secondary Outcomes
- Not applicable(Not applicable)
Investigators
Dr. Shrikant Wagh
Dr D Y Patil College of Ayurved and Research Centre