A clinical study of Waram Tajawif al -Anf Muzmin (chronic sinusitis) to evaluate the efficacy of ITRIFAL USTUKHUDDUS and SHARBAT E SADAR
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical assessment will be done and the response to treatment will be
研究概览
简要总结
Waram TajaÌ„wiÌ„f al-Anf Muzmin is called chronic sinusitis in modern medicine, which is a chronic inflammatory condition of upper respiratory tract involving the paranasal sinuses.It is usually followed by coryza and cold or sometime resultant of dental infection deeply seated in upper jaw. Inflammation of sinuses nearly always involves the nasal mucosa ‘Rhinosinusitis, is now generally preferred term for this condition. In Unani System of Medicine, there are some principles for nomenclature of disease. The disease is not named as “iltihabâ€, instead it is named as “Waramâ€. Therefore, iltihab meaning Sozish wa Lapat (burning and flame) has been described as a symptom of Nazla Harr not as a disease. Thus, the term Waram Tajawif al-Anaf is more appropriate for sinusitis. Chronic sinusitis affects approximately 14.7% of the general population.The National Institute of Allergy and Infectious Diseases (NIAID) estimates 134 million Indians suffer from chronic sinusitis. Among Indians the disease is more widespread than diabetes, asthma or coronary artery disease which results in a large financial burden on society. It is among the most typical causes for people to seek medical attention. Although sinusitis symptoms are not life-threatening, they are linked to a sharp decline in quality of life (QOL) and QOL scores equalize serious illness such as congestive heart failure, angina pectoris and chronic obstructive pulmonary disease. The term "chronic sinusitis" refers to an inflammatory condition affecting the Sino nasal mucosa that lasts for more than 12 weeks and is characterised by at least two of the following symptoms: nasal obstruction, blockage, or congestion, nasal discharge (anterior/posterior nasal drip), facial pain or pressure, loss of smell, coughing, and endoscopic disease signs or relevant CT scan changes. The etiopathogenesis of Chronic sinusitis continues to be the focus of much debate and research in the field of rhinology and remains controversial. Multifactorial factors altering the host- environment interaction such as bacteria, fungi, viruses, allergens, or environmental toxins may trigger the inflammatory process. Medical management of Chronic Sinusitis often require combining multiple medications including antibiotics, nasal decongestant, topical nasal steroid and / or oral steroids and saline irrigation. Side effects of, steroids antibiotics and decongestant are Cushing syndrome, steroid induce Diabetes, gastric ulcers, GI bleeding and avascular necrosis of femoral head, epistaxis, dry nose, burning nasal itching, pharyngitis, otitis, change of taste, eczema, nausea, diarrhoea, common cold, GI symptoms skin rashes reversible elevation of liver enzymes Patient who does not respond to full medical treatment alone requires surgical treatment with endoscopic sinus surgery. Potential development of microbial resistance remains a salutary concern in these patients due to repeated and prolong use of antibiotics. there is no solution for permanent relief and need an alternative approach which is safe and effective. The limitations of management of Chronic sinusitis available in modern medicine necessitate a scientific search for safe, efficient, and practical medications for the condition. There are numerous single as well as compound Unani drugs which have been used for centuries to treat Waram Tajawif al-Anf Muzmin, but many of them have not been evaluated clinically on scientific parameters. Keeping this in view, the present study is designed to evaluate the comparative efficacy of ITRIFAL USTUKHUDDUS and SHARBAT E SADAR in case of chronic sinusitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of any sex, aged 18-50 years
- •Duration of the disease greater than 12 week.
- •Patient having at least two out of four cardinal symptoms i.e., facial pain/pressure, hyposmia/anosmia, nasal obstruction, and nasal discharge for at least 12 consecutive weeks
- •Patient having any of the following symptoms like rhinorrhoea, nasal congestion, frontal headache, nasal itching, impaired sense of smell and frequent sneezing for more than 12 weeks.
- •Positive X-ray PNS finding like Thickened mucosal lining, opacity of sinus.
排除标准
- •Patient aged below 18 years or above 50 years
- •Patient with deviated nasal septum
- •Local pathology such as mucocele, cyst, antrochoanal polyp, facial trauma.
- •Diabetes mellitus and any other illness requiring long term treatment.
- •Pregnant or Lactating Women.
- •Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction
- •Known cases of Immunocompromised states like HIV/ AIDS, etc.
- •or Malignancies
- •Patient not willing to attend regular treatment and follow-up for the entire duration of study
- •Mentally retarded patients.
- •Patient having history of any surgery of nose or paranasal sinuses.
- •Patient having history of trauma to nose or sinus area.
- •Patient of pulmonary Koch’s or having history of epistaxis.
- •Any medical condition where physician feels that participation in the study could be detrimental to patient’s well- being.
- •Alcoholic and Drug addicted patient.
结局指标
主要结局
Clinical assessment will be done and the response to treatment will be
时间窗: Week 2, 4 and 6.
assessed using the following parameters:
时间窗: Week 2, 4 and 6.
1. Visual Analogue Scale
时间窗: Week 2, 4 and 6.
次要结局
- 1. Visual Analogue Scale(Week 2, 4 & 6.)
研究者
Farhat Jahan
State Unani Medical College
