CLINICAL EVALUATION OF AGASHTYA HARITAKI RASAYANA AND APAMARGA KSHARA IN THE MANAGEMENT OF MILD STABLE BRONCHIAL ASTHMA (TAMAK SHWASA)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1. Change in Asthma Control Questionnaire (ACQ)
研究概览
简要总结
Bronchial asthma is achronic inflammatory disorder of the airway and the most common distressingdisease affecting 3-5% of the total population [1]. In 1998 the national asthmacampaign estimated the prevalence of diagnosed asthma cases in India to be 3.4million. [2] In the field of allergic respiratory diseases, several indigenousdrugs have been successfully tested and used as conservative therapy in asthma.Ayurveda, the great indigenous system of medicine of India is a completehealthcare system and deals with the preventive and curative aspects of themany diseases. Ayurveda refers to bronchial asthma as Tamaka Swasa andcontributes several modalities of treatment for the same.[3] Among all thetreatment modalities polyherbal combinations are said to be well-accepted, safeand effective in asthma. [4] No satisfactory management is not available inconventional therapy to provide a adequate remedy of this disease. In thepresent study, the drugs like Agashtya Haritaki Rasayana (APIPart II, Vol-IV) and Apamarga Kshara (API Part II, Vol-I) have beentaken. Both the drugs have been used for Tamaka Swasa effectively.Therefore both the above drugs are taken into the study with the hypothesisthat, to act effectively for the proper Samprapti vighatana, byalleviating the involved dosha.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex with age between 18 to 60 years.
- •2.Diagnosed cases of the mild predominant or persistent stable Bronchial Asthma (Tamaka Shwasa) (as per GINA Guideline) (Stable asthma controller therapy dose i.e no changes in regular anti-asthma medication & Symptoms: ≤ 2 days/week; Night time awakenings: ≤ 2 times/month; Interference with normal activities: None; Short-acting β2-agonist use for symptom control: ≤ 2 days/week; for 3 months prior to enrolment).
- •3.FEV1 >80% of the predicted value 4.Patients willing to participate and written consent.
排除标准
- •1.Patients with FEV1 < 80% of the predicted value.
- •2.Patients with uncontrolled Diabetes Mellitus having HbA1C > 8% 3.Patients who have history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •4.Symptomatic patients with clinical evidence of Heart failure 5.Known cases of HIV and AIDS.
- •6.Known cases of malignancy 7.Patient taking participation in any other clinical trial.
- •8.Women who are planning for conception / pregnant or lactating.
- •9.Patients with concurrent serious hepatic disorders (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 2 times upper normal limit) or Renal Disorders (defined as S.
- •Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease (COPD) 10.H/o hypersensitivity to any of the trial drugs or their ingredients 11.Any other condition which the Investigator thinks may jeopardize the study.
结局指标
主要结局
1. Change in Asthma Control Questionnaire (ACQ)
时间窗: On baseline,14th day,28th day, 42th day, 56th day, 70th day, 84th day and 98th day
2. Frequency of need for control medication
时间窗: On baseline,14th day,28th day, 42th day, 56th day, 70th day, 84th day and 98th day
次要结局
- 1.Any improvement in FEV1(2.Changes in serum CRP, IgE)