A prospective open labelled, single arm, non-randomized, single centric, phase II clinical trial to determine the effectiveness of Anda Vayu Mathirai in the management of Kuthikaal Vatham (Plantar fasciitis).
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This is a PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON-RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF ANDA VAYU MATHIRAI IN THE MANAGEMENT OF KUTHIKAAL VATHAM (PLANTAR FASCIITIS).The trial drug ANDA VAYU MATHIRAI is freshly prepared and will be administered at a dosage one pill (twice a day orally) with hot water as adjuvant for 45 days 40 know KUTHIKAAL VATHAM (PLANTAR FASCIITIS) patients (20 OP&20 IP).The primary outcome will be determining clinical evidence support for the effect of ANDA VAYU MATHIRAI (INTERNAL) in the management of KUTHIKAL VATHAM (Plantar Fasciitis).
The secondary outcome will be to collects various siddha literatures and modern journals for literature review on KUTHIKAL VATHM , To evaluate physicochemical, phytochemical, bio chemical, analysis of ANDA VAYU *MATHIRAI ,*To study about the prevalence of KUTHIKAL VATHAM in relation with diet and lifestyle ,To evaluate the Pharmacological activities of *ANDA VAYU MATHIRAI ,*To evaluate Siddha Parameters (including Envagai thervugal) ,To evaluate modern parametric changes in KUTHIKAL VATHAM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Ability to understand consent form for participation in the study.
- •2.subjects having pain at least 2-6 VAS scale score ( confirmed through PFPS Plantar Fasciitis Pain,Scale) 3.Pain with palpation of the proximal insertion of the plantar fascia 4.Positive windlass test.
排除标准
- •1.Previous Surgery on foot 2.Calcaneal Stress fracture 3.Tarsal Tunnel Syndrome 4.Heel Spurs 5.Pregnant women 6.Neurological disorders.
研究者
Dr Kanapathipillai Premaragavan
Government siddha medical college and hospital