Correlation between Jivha Samata (coated tongue) and Disease Activity in cases of Amavata (Rheumatoid Arthritis): a Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Correlation between Coating (Samata) of tongue and Clinical Disease Activity Index in patients with Rheumatoid Arthritis (Amavata)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Correlation between Coating (Samata) of tongue and Clinical Disease Activity Index in patients with Rheumatoid Arthritis (Amavata)
时间窗: Single patient visit (cross-sectional study)
次要结局
- Not applicable(Not applicable)
研究者
Dr. Shrikant Wagh
Dr D Y Patil College of Ayurved and Research Centre