Comparative clinical study on the efficacy of Habb-e-Mafasil with Roghan-e-Banafsha and Habb-e-Gul-e-Aakh with Roghan-e-Haft Barg in Wajaʹur Rukbah (Knee Osteoarthritis)- A Randomized Clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Reduction in the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC –Modified CRD Pune version)
研究概览
简要总结
Objective of the study:
The objective of the study is to compare the efficacy of Habb-e-Mafasil and Roghan-e-Banafsha with Habb-e-Gul-e-Aakh and Roghan-e-Haft Barg in Wajaʹur Rukbah (Knee osteoarthritis).
Study design: Single blind, Randomized Comparative Clinical Trial
**Sample size:**44 subjects, 22 in each group
Intervention:
Test Group:
Habb-e- Mafasil: Dose: 3 gm per day in two divided doses (2 pills of 750mg twice a day after meals)
Route of administration: Oral
Roghan-e- Banafsha
Dose: 10-15 ml per day
Route of administration: Local
Control Group:
Habb**-e- Gul-e- Aakh**
Dose: 2 gm per day in two divided doses (2 pills of 500 mg twice a day after meals)
Route of administration: Oral
Roghan**-e- Haft Barg**
Dose: 10-15 ml per day
Primary outcome:
Reduction in the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC –Modified CRD Pune version)
Secondary outcome:
-
Reduction in Pain intensity as per WOMAC (Modified CRD Pune version) pain scale
-
Reduction in stiffness as per WOMAC (Modified CRD Pune version) stiffness scale
-
Reduction in Restrictions of movements as per WOMAC (Modified CRD Pune version) physical activity scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosed cases of OA Knee Joint as per ACR Criteria16 (clinical, radiographical and laboratory).
- •2.Subjects of all genders aged 45-70 years.
- •3.Grade I and II of Kellgren Lawrence grading scale17.
排除标准
- •1.Subjects who experience a rapid worsening of knee symptoms, have a hot swollen knee, have a previous knee replacement on the affected knee, have a history of significant trauma to the affected knee, have a joint injection or arthroscopy in the past 6 months, or have any major surgery in the last year.
- •2.Subjects currently taking, or in the past 3 months were taking, pain-relieving medications (e.g., nonsteroidal anti-inflammatory drugs, analgesics, and corticosteroids).
- •3.Subjects diagnosed with gout or pseudo gout within the last 3 months, have a history of gout in the knee joint, diagnosed with other inflammatory arthritis (e.g., rheumatoid arthritis, septic arthritis), and malignancy, diagnosed with a complex pain disorder or severe immobility (e.g., complex regional pain syndrome, severe back pain, multiple sclerosis, muscular dystrophy, Parkinson’s disease, or hemiplegia).
- •4.Participants with a recent diagnosis of, and/or currently suffering from uncontrolled medical conditions including but not limited to diabetes (RBS≥180mg/dl), hypertension (≥140/90mmHg), cardiovascular disease gall bladder disease/gallstones/biliary disease, endocrine disease, or malignancies.
- •5.Pregnant and lactating women.
结局指标
主要结局
Reduction in the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC –Modified CRD Pune version)
时间窗: 0th day, 7th day, 14th day, 21th day, and 28th day
次要结局
- 1)Reduction in Pain intensity as per WOMAC (Modified CRD Pune version) pain scale(2)Reduction in stiffness as per WOMAC (Modified CRD Pune version) stiffness scale)
研究者
Dr Mohd Razaullah
National Institute of Unani Medicine