A Double-Arm clinical trial to evaluate the efficacy of Raktamokshana along with Erandataila pana in comparison to Wax Therapy along with Exercise in the management of Plantar Fasciitis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
Plantar fasciitis is a common degenerative condition of the plantar fascia at the medial calcaneal tuberosity, affecting about 10% of the population annually. Symptoms include heel pain, morning stiffness, and difficulty in daily activities. Current treatments include physiotherapy, wax therapy, NSAIDs, and corticosteroid injections; however, long-term use of steroids and NSAIDs may cause adverse effects. In Ayurveda, the condition is correlated with Vatakantaka, for which classics prescribe Raktamokshana (siravyadha) and Erandataila Pana .
Modern studies highlight the role of wax therapy and stretching exercises in improving circulation, pain, and function, though requiring frequent sessions. Case studies on Raktamokshana with Erandataila suggest significant improvement with fewer sittings, indicating cost-effectiveness and reduced patient burden.
This open-label, double-arm comparative clinical trial will recruit 36 patients (20–65 yrs) with plantar fasciitis from OPD/IPD of Amrita School of Ayurveda. Group A will receive Raktamokshana (Siravyadha, 3 sittings) with Erandataila Pana (10 ml daily), while Group B will undergo Wax therapy (10 sessions) with Exercise. Assessments will be made using VAS score, Foot Function Index (FFI), ankle range of motion, and Windlass test over 15 days.
The research hypothesis states that there is a significant difference between the two interventions in reducing pain, improving foot function, and ankle range of motion. Statistical analysis will be done using Independent t-test / Mann–Whitney U test, and Friedman test for intra-group comparisons.
The study aims to establish whether fewer sessions of Raktamokshana with Erandataila Pana can provide results comparable or superior to conventional wax therapy with exercise, potentially offering an effective and economical treatment option for plantar fasciitis.
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
- •Patients between 20- 65 yrs of age are selected irrespective of their religion, sex, occupation and socio economic status who were diagnosed on the basis of signs and symptoms found in Plantar fasciitis.
- •Patients with plantar heel pain provoking by first few steps in morning ,standing for prolonged time or sitting.
- •Patients with tenderness localised at origin of plantar fascia on medial calcaneal tubercle.
- •Positive Windlass test.
- •Patients who are not suffering from any bleeding disorders.
排除标准
- •Patients who are contraindicated to Raktamokshana.
- •Patient associated with calcaneal spur or calcaneal stress fracture.
- •Patients with previous history of foot surgeries.
- •Patients associated with generalised inflammatory conditions including Rheumatoid Arthritis, Gout .
- •Patients associated with diabetes mellitus, skin rashes, burns and allergic conditions over heel region.
- •Patients with varicose ulcer in foot.
- •Patients who uses NSAID daily.
研究者
Dr ATHULYA P V
AMRITA SCHOOL OF AYURVEDA