CTRI/2025/07/091420尚未招募Phase 3 4
Evaluation of efficacy and safety of Shadbindu Taila Marsha Nasya and Chitraka Haritaki Avaleha in Chronic Rhinosinusitis: A Randomized Controlled Multicenter Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Primary Outcome: The change in terms of
研究概览
简要总结
| The prevalence |
| of chronic rhinosinusitis (CRS) measured in epidemiologic studies is 5% to |
| 12%. Chronic Rhinosinusitis is one of the important global health problems |
| defined as inflammation of the mucous membrane of the nose and paranasal |
| sinuses. Chronic rhinosinusitis refers to a condition that lasts at least 12 |
| weeks, despite attempts to treat it, and causes at least two of the symptoms; |
| nasal congestion, mucus discharge from the nose or mucus that drips down the |
| back of the throat, facial pain, pressure, or fullness, a decreased sense of |
| smell. The proximity of the brain to the sinuses makes the most dangerous |
| complication of Chronic Rhinosinusitis, particularly involving the frontal |
| and sphenoid sinuses, infection of the brain by the invasion of anaerobic bacteria through the bones |
| or blood vessels. Abscesses, |
| meningitis and other life-threatening conditions may result. In extreme |
| cases, the patient may experience mild personality changes, headaches, |
| altered consciousness, visual problems, seizures, coma and possibly death. |
| The treatment strategy for Chronic Rhinosinusitis mainly includes the use of |
| topical decongestants, saline nasal drops, nasal saline irrigations, nasal |
| steroids, antihistamines, antibiotics and in some cases surgical interventions. |
| Even though not a life-threatening condition it produces difficulty in |
| carrying out day to day activities and greatly affects the quality of life. Pinasa Roga is one such chronic disease which affects |
| the nose and nasal passages*. Pinasa* is due to vitiated Vata Kapha, withNasaavarodha (Nasal obstruction), Nasashosha (dryness of the |
| nose), Gandha agyana (abnormal perception of smell) as the |
| characteristic symptoms. The various etiological factors mentioned (faulty |
| life style & regimen) leads to Agnimandya and Aama which is |
| the main causative factor for the disease. Ayurveda being a life science advocated preventive and curative |
| measures for the treatment of various chronic |
| diseases. Earlier researches have |
| proved the effectiveness of Ayurvedic treatment in the management of Pinasa |
| Roga. Chitraka Haritaki Lehya is mentioned in Nasarogadhikara Chikitsa |
| in Chakradutta (58/31-33). Shadbindu Tailais medication described in *Bhaishajyaratnavali Siroroga chikitsa |
| Prakarana* for the management of almost all Urdhajatrugata Rogas (65/81- 83). |
| Total 160 patients (80 at each participating center) will be included in the |
| study. The observations and discussion will be |
| made according to statistical analysis on different clinical & objective parameters and scores of questionnaires (Chronic Rhinosinusitis |
| Questionnaire). This |
| study has been proposed to evaluate the efficacy and |
| safety of Administration of Shadbindu Taila Marsha Nasya and Chitraka Haritaki Avleha in Chronic Rhinosinusitis. |
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between the age group of 18 to 60 years.
- •Patients suffering with Pinasa (Chronic Rhinosinusitis) who are fulfilling the diagnostic criteria based on American system of Academy (AAO-HNS) will be selected for the present study.
- •Twelve weeks or longer of two or more of the following signs and symptoms: Mucopurulent drainage (anterior, posterior or both), Nasal obstruction (congestion), Facial pain-pressure-fullness Decreased sense of smell (b).
- •AND inflammation is documented by one or more of the following findings: Purulent (not clear) mucus or edema in the middle meatus or anterior ethmoid region, Polyps in nasal cavity or the middle meatus, and/or Radiographic imaging showing inflammation of the paranasal sinuses
- •Willing to participate in study.
排除标准
- •Patients below 18 and above 60 years of age.
- •History of chronic nasal or upper respiratory tract symptoms or disorders other than Chronic Rhinosinusitis.
- •Patients who are on treatment with H1 antihistamine medication, non-steroidal analgesics, Leukotriene antagonists.
- •Cases of fungal sinusitis (On Non- Contrast CT-PNS; Hypoattenuating mucosal thickening, intranasal/ intrasinus soft tissue attenuation/ opacification, associated osseous erosions, hyperdense fungal hyphae within sinus).
- •Presence of secondary immune deficiency state: HIV, organ transplant, Malignancy, Treatment with corticosteroids.
- •Known cases of Hepatitis B and C positive.
- •Pregnancy & Lactation.
- •Patients suffering from chronic debilitating disease like tuberculosis, rheumatoid arthritis, Pulmonary Dysfunction (Bronchial Asthma and / or.
结局指标
主要结局
Primary Outcome: The change in terms of
时间窗: On base line, 56th day, 84th day
SNOT-22 score (Sino-Nasal Outcome Test)
时间窗: On base line, 56th day, 84th day
次要结局
- The change in RSDI score (Rhinosinusitis Disability Index)(On base line 56th day 84th day)
- Lund-Mackay scores of computed tomography (CT) scan of paranasal sinuses(On base line, 56th day)
- Change in the laboratory safety parameters from baseline(baseline, 56TH Day)
- Dependence on rescue medicines(On base line, 14th day, 28th day, 42th day, 56th day)
- Incidence of treatment emergent adverse events(On base line, 14th day, 28th day, 42th day, 56th day)
研究者
Dr Shweta Mata
Central Ayurveda Research Institute New Delhi
研究点 (2)
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