A Controlled Clinical Study to Evaluate the Safety and Efficacy of Jadwar (Delphinium denudatum) in the Management of Chronic Sinusitis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Chronic sinusitis is a common inflammatory condition of the paranasal sinuses persisting for more than 12 weeks and significantly affecting patients’ quality of life. Conventional treatments such as antihistamines, corticosteroids, antibiotics, and decongestants provide symptomatic relief but are often associated with adverse effects, especially with prolonged use.
In Unani medicine, chronic sinusitis (Waram Tajaweef-e-Anf Muzmin) is attributed to humoral imbalance and Su’-e-Mizaj. Jadwar (Delphinium denudatum) is a well-known Unani single drug traditionally used for respiratory and inflammatory conditions due to its anti-inflammatory, analgesic, and neuroprotective properties. However, scientific clinical validation of its efficacy in chronic sinusitis remains limited.
The present study is a randomized, single-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of Jadwar in patients with chronic sinusitis. A total of 60 eligible participants aged 18-60 years will be randomly allocated into two groups: Group A (Jadwar 500 mg capsule twice daily) and Group B (placebo) for 30 days.
The primary outcome will be assessed using change in SNOT-22 score, and the secondary outcome will include quality of life assessment using SF-12 questionnaire. Safety will be evaluated through laboratory investigations and monitoring of adverse events.
The study aims to provide scientific evidence for the therapeutic role of Jadwar in the management of chronic sinusitis.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 18 and 60 years of either gender.
- •Clinically diagnosed cases of chronic sinusitis confirmed by nasal endoscopy and/or radiological imaging.
- •Patients experiencing symptoms such as nasal congestion, facial pain or pressure, headache, or post-nasal drip persisting for at least 4 weeks.
- •Patients who are willing to provide written informed consent and comply with the study protocol and follow-up schedule.
排除标准
- •Pregnant and lactating women.
- •Patients with a history of recent nasal or sinus surgery.
- •Patients suffering from any major systemic disorder.
- •Patients with immunocompromised conditions such as HIV or tuberculosis.
- •Patients who have used corticosteroids, antibiotics, or other treatments for sinusitis within the past four weeks.
- •Patients with nasal polyps or significant sinonasal structural abnormalities (e.g., markedly deviated nasal septum).
研究者
Dr Shoaib Khan
Jamia Hamdard