Efficacy of Haridrakhanda Orally and Anu Taila Nasya with and without Saraladi Dhoomapana in the management of Vataja Pratishyaya (Allergic Rhinitis)- An Open Labelled Randomized Comparative Clinical Trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1) ANTERIOR RHINOSCOPIC EXAMINATION
研究概览
简要总结
Introduction:Many research works have been carried out on Vataja Pratishyaya (Allergic Rhinitis) in Ayurveda and also in contemporary system of medicine, Vataja Pratishyaya (Allergic Rhinitis) still remains as a hazardous problem as it has more chances of recurrent episodes and serious complications. Haridrakhanda has Rasayana and Rogahara property. It may give an immune modulator effect which will be effective in the management of Vataja Pratishyaya (Allergic Rhinitis). Nasya with Anu Taila will have a great effect on symptoms of Pratishyaya, as Nasa is considered as direct gateway to the Shirah. Dhoomapana is one of the best therapies for diseases of Supra clavicular region specially Vata Kapha predominancy. So, the study has been planned to find out the management from the ancient texts which is effective and cheap. Information on the Trial procedure and Drug: Here in Group A, we are giving 6gm of Haridrakhanda twice a day with lukewarm water before meal, 6 drops of Anu Taila Nasya in each nostril in morning (3 sittings of Nasya for 7 days with interval of 3 days) followed by Saraladi Dhoomapana 9 puffs in each nostril. In Group B, 6gm of Haridrakhanda twice a day with lukewarm water before meal and 6 drops of Anu Taila Nasya in each nostril in morning (3 sittings of Nasya for 7 days each with interval of 3 days). We assure that we will prepare formulations with as per S.O.P in the Pharmacy of I.T.R.A. Description of the Process: In present study, participants who will be clinically diagnosed and confirmed cases of Vataja Pratishyaya (Allergic Rhinitis) enlisted in inclusion criteria will be enrolled, minimum 30 patients and will be divided in to 2 groups by computer generated randomization technique, having minimum 15 patients in one group. In Group A, they will be given 6gm of Haridrakhanda twice a day with lukewarm water before meal, 6 drops of Anu Taila Nasya in each nostril in morning (3 sittings of Nasya for 7 days with interval of 3 days) followed by Saraladi Dhoomapana 9 puffs in each nostril. In Group B, 6gm of Haridrakhanda twice a day with lukewarm water before meal and 6 drops of Anu Taila Nasya in each nostril in morning (3 sittings of Nasya for 7 days each with interval of 3 days) Follow-up: Follow up will be for one month duration at interval of 15 days. Side Effects: We will follow closely and keep track of any unwanted effects. We may use some other medicines or stop the usage of drug to decrease the symptoms of the side effects. Results: The efficacy of the therapy will be assessed on the basis of subjective criteria. Benefits: Project will help us to resolve the research question. There may not be any benefit for the society at this stage of the research, but future generations are likely to be benefited as to find out proper treatment protocol for the management of Rhinitis. Collected information from this research project will be kept confidential, all outcomes will be noted in tabular form and appropriate statistical tests will be applied to compare the effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patient between age group of 18 and 50 years.
- •2.The diagnosis of the disease shall be done with signs and symptoms of Vataja Pratishyaya (Allergic Rhinitis) i.e., Gala-Talu-Austha Shosha (Dryness), Svaropaghata (Hoarsness of voice), Kshavthu (Sneezing), Nasa Srava (Nasal discharge), Nasaavrodha (Nasal obstruction).
排除标准
- •1.Patient below 18 and above 50 years.
- •2.Cases which require surgical intervention like Nasal polyps would be excluded.
- •3.Patients suffering from any chronic debilitating disease like Tuberculosis, Diabetes Mellitus, Asthma and other respiratory or nasal problems.
- ••Pregnant ladies and lactating mothers.
结局指标
主要结局
1) ANTERIOR RHINOSCOPIC EXAMINATION
时间窗: 30 DAYS. | WILL BE ASSESED ON 0 DAY (BEFORE) AND 31ST DAY (AFTER) THE TREATMENT.
2) NASAL ENDOSCOPY
时间窗: 30 DAYS. | WILL BE ASSESED ON 0 DAY (BEFORE) AND 31ST DAY (AFTER) THE TREATMENT.
次要结局
- 1) KSHAVATHU (SNEEZING)(2) NASA SRAVA (NASAL DISCHARGE))
