A Clinical Study to Evaluate the Efficacy and Safety of Unani Formulation in the Management of Waja-al-Unuq (Cervical Spondylosis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 1.Improvement in Patient’s Global Assessment on VAS
研究概览
简要总结
The dissertation titled “A Clinical Study to Evaluate the Efficacy and Safety of Unani Formulation in the Management of Waja-al-Unuq (Cervical Spondylosis)” by Dr. Rukhsar Aslam focuses on assessing a traditional Unani treatment for cervical spondylosis a degenerative condition of the cervical spine. The study aims to scientifically validate the effectiveness and safety of a specific Unani polyherbal formulation, both orally (powder form) and topically (Roghan-e-Zanjabeel).
Key Components:
Background: Cervical spondylosis is a common spinal issue causing neck pain, stiffness, and neurological symptoms. Unani medicine refers to it as Waja-al-Unuq, part of the broader category Waja-al-Mafasil (joint pain), attributing the cause to abnormal phlegm accumulation.
Objective: To evaluate the efficacy and safety of a Unani formulation made of Suranjan sheerin, Zanjabeel, Zeera kirmani, Sibr (oral) and Roghan-e-Zanjabeel (local application).
Methodology:
Pre-post single-arm clinical trial.
35 patients aged 25–60 with radiologically diagnosed cervical spondylosis.
Treatment duration: 60 days.
Assessment based on clinical symptoms Kettler’s Grading System VAS (Visual Analogue Scale) and safety lab tests (LFT KFT RBS).
Ethical Clearance: Sought and approved by the institutional ethics committee.
Conclusion: This study seeks to provide a safer affordable alternative to conventional therapies for cervical spondylosis using traditional Unani methods contributing to evidence-based validation of classical treatments.
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
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically stable patient having complain of Cervical spondylosis (neck pain tenderness paraesthesia or numbness and restricted movement of neck).
- •Radiologically diagnosed patients of Waja-al-Unuq (C.S) Using Kettlers Grading Scale based on cervical disc degeneration (with the concern of radiologist).
- •Patients belonging to 25 to 60 years of age in both sexes
- •Patients able to participate in the study and ready to follow the instructions and sign the consent form.
排除标准
- •Pregnancy, lactating mothers and women using OCPs drug.
- •Spinal tumour or cancer.
- •Any post healed cervical fracture, congenital spinal deformity.
- •Patients having systemic as well as metabolic diseases like liver, kidney, Cardiac, pulmonary diseases, Epilepsy, Diabetes and HTN.
- •Patient taking corticosteroids.
- •Cervical rib syndrome.
- •Raw skin lesion on neck.
- •Patients unsure about attending treatment schedule regularly.
- •Patients with the history of trauma and accidents.
- •Patients suffering from immunological diseases like HIV, hepatitis and malignancy.
- •Grade 3 scale of Kettler’s Grading System.
结局指标
主要结局
1.Improvement in Patient’s Global Assessment on VAS
时间窗: Clinical assessment will be done at Baseline, 2nd, 4th, 6th and 8th weeks.
2.Improvement in Clinical symptoms on Likert Scale
时间窗: Clinical assessment will be done at Baseline, 2nd, 4th, 6th and 8th weeks.
次要结局
- Reduction in Kettlers Grading System.(Clinical assessment will be done at Baseline & 8th weeks.)
研究者
DR RUKHSAR ASLAM
State Takmeel ut Tib College And Hospital