A Randomized controlled pilot clinical study to evaluate the efficacy of Inkibab (medicated steam therapy) in the treatment of Knee osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
Osteoarthritis (OA), referred to as Waja al Mafasil in Unani medicine, is a degenerative joint disorder that commonly affects the knee, causing pain, stiffness, and impaired mobility. This randomized controlled pilot study aims to evaluate the efficacy of Inkibab (medicated steam therapy) in treating knee osteoarthritis. The study aims to compare the therapeutic effects of Inkibab with Unani medicines-Babuna (Matricaria chamomilla L.), Nakhuna (Trigonella glabra subsp. uncata (Boiss. & Noe) Lassen), and Gul-e-Tesu (Butea monosperma (Lam.) Kuntze) compared to plain water steam therapy.
A total of 10 patients aged 30-60 years, diagnosed with knee OA, will be randomly divided into two groups. Group A (Test group) will receive medicated steam therapy, while Group B (Control group) will undergo plain water steam therapy. Both groups will receive therapy for 10 minutes daily over 10 days. Efficacy will be assessed using the Visual Analogue Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and rescue medication use. Safety will be monitored through pre- and post-treatment investigations. This study aims to assess the comparative efficacy of Inkibab with Unani medicines compared to non-medicated steam in osteoarthritis symptom relief, and will also help in substantiating the principles of Unani medicine in which murkhi (laxity-producing drugs) and muhallil (resolvent) drugs are prescribed for symptom-relief in osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of Knee OA in age groups of 30 to 60 years Subjective pain intensity of 20 or more at baseline on Visual Analogue Scale (VAS).
- •Clinically stable patients Patients of all genders Patients willing to sign the informed consent form and participate in the trial voluntarily.
排除标准
- •Diabetes mellitus Type-1 and uncontrolled Type-2 Clinically unstable patients.
- •Patients suffering from any acute or chronic disorder in which vitals are beyond normal values, or there are clinical signs of electrolyte and metabolic disturbances Pregnant and lactating mothers Terminally ill patients Patients below 30 years and above 60 years of age Patients who fail to give written informed consent.
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: 1st day, 10th day
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 1st day, 10th day
Rescue Medication Use
时间窗: 1st day, 10th day
次要结局
- Mizaj (temperament assessment)(Baseline)