跳至主要内容
临床试验/CTRI/2024/12/078237
CTRI/2024/12/078237招募中不适用

Systemic Clinical Features of Shukrakshaya in Amavata (Inflammatory Polyarthritis)

Dr Shrikant Wagh1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
25
试验地点
1
主要终点
Correlation between shukrakshaya and severity of ama in the patients of inflammatory polyarthritis (amavata) and correlation between disease activity and severity of shukrakshaya in the these patients.

研究概览

简要总结

Introduction

Rheumatoid arthritis (RA) is a prototype of amavata. Ama is one of the causes of dhatukshaya which is not mentioned in the listed features of amavata. No studies attempt to establish the association of dhatukshaya in amavata. Shukrakshaya can be assessed by the presence of clinical features and the FACIT fatigue scale. A preliminary study is, therefore, planned to understand the association of amavata and shukrakshaya.

Materials and Methods

A minimum of 25 OPD patients suffering from amavata (RA as per ACR/EULAR criteria 2010) will be studied at Lupus Clinic, Pune 411002. Clinical features of amavata including their severity, and the features of ama and its severity (assessed by validated instrument) will be studied along with features of shukrakshaya described in Ayurveda viz. anaemia (complete hemogram), dry mouth (short xerostomia inventory), and FACIT fatigue scale* along with Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale (for weakness, tiredness, and fatigue).

Outcome

Analysis and interpretation of study findings to know the correlation between the clinical features of amavata (RA) and features of shukrakshaya viz. anaemia, dry mouth, and fatigue. The results will be disseminated on an appropriate platform (conference paper/journal article)

*License for use of FACIT (English and Marathi versions obtained on 16th September 2024)

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

  • Patients with five or more painful and swollen joints
  • Age above 18 years
  • Patients who sign the informed consent form and willing to give correct information.

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 990 F)
  • Neurological disorders that limit the 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
  • Long-acting glucocorticoids or disease modifying antirheumatic drugs during previous three months
  • Nonsteroidal anti-inflammatory drugs or glucocorticoids within previous 24 hours of examination.

结局指标

主要结局

Correlation between shukrakshaya and severity of ama in the patients of inflammatory polyarthritis (amavata) and correlation between disease activity and severity of shukrakshaya in the these patients.

时间窗: Single visit (Cross-sectional study)

次要结局

  • Not applicable(Not applicable)

研究者

发起方
Dr Shrikant Wagh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shrikant Wagh

Dr D Y Patil College of Ayurved and Research Centre

研究点 (1)

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