A Randomised Comparative Clinical study to Evaluate the Efficacy of Pushkaramoola Churna with Bharangikanadi Kashaya and Vamana Karma in the Management of Tamaka Shwasa with Special Reference to Bronchial Asthma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes in subjective criterias;
研究概览
简要总结
Aim of study
To Assess the Clinical Efficacy and Safety of Combination of Pushkaramoola Churna with Bharangikanadi Kashaya and Vamana karma in the Management of Tamaka Shwasa with Special Reference to Bronchial Asthma.
Objectives of study
To study different breathing disorders described in Ayurvedic classics with special reference to tamaka swasa
To study and analyse Ayurvedic management of tamaka swasa and latest scientific researches on it
To evaluate the effect of Pushkaramoola churna with Bharangikanadi kashaya along with Vamana karma in tamaka swasa
To To evaluate the effect of Pushkaramoola churna with Bharangikanadi kashaya without Vamana karma in tamaka swasa
To To compare the effect of Pushkaramoola churna with Bharangikanadi kashaya with and without Vamana karma
Study design
A total of 70 Patients will be randomly divided into 2 groups as follows-
Group A – will be administer with Pushkaramoola churna-2g and Bharangikanadi Kashaya (50ml twice in a day, morning and evening on empty stomach)
Group B – will be administer with Vamana karma followed by samana therapy - Pushkaramoola churna – 2g with Bharangikanadi Kashaya (50ml twice in a day, morning and evening on empty stomach)
Time line - Treatment period – 3 months
Follow up period – on every 15th day
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients willing to participate in above trial and given written consent 2.Patient of either sex greater than 20 years and less than 50 years 3.Patient with stable bronchial asthma as per WHO GINA Guidelines for at least 6 weeks prior to study entry.(Episodes of Wheezing, shortness of breath, Chest tightness, and cough, that vary over time and in intensity, together with variable expiratory airflow limitation.
- •GINA definition of Bronchial asthma) Positive test of reversibility:.
- •a.Symptomatic patients.
- •an improvement of 60L/min or more than 20% in PEFR, 10 minutes after the inhalation of 200mcg of salbutamol b.Asymptomatic patients – 60L/min or more than 20% fall in PEFR by provocation with 5-10 minutes of physical exercise, followed by reversal upon inhalation of 200mcg of salbutamol, when assessed after 10 minutes. 4.FEV1 more than 50% and less than 80% 5.FEV1 and FEV ratio less than 70% 6.Patient presenting with features of Tamaka shwasa as in ayurvedic classical text books.
排除标准
- •1.Patients with PEFR less than 50% and or FEV1 less than 50% of predicted value 2.Pregnant and lactating women 3.Patient with poorly controlled diabetes mellitus (HbA1c greater than 8%) 4.Patient with poorly controlled Hypertension (Systolic greater than 160 mm Hg and Diastolic greater than 100 mm of Hg) 5.Patients on prolonged (more than 6 weeks) medication with corticosteroids, bronchodilators, mast cells stabilizers, antidepressants, anticholinergics, or any other drugs that may have an influence on the outcome of the study.
- •6.Smoker or alcoholic or drug abusers 7.Patients who have a past history of Atrial fibrillation, Acute Coronary Syndrome, Myocardial Infraction, stroke or severe Arrhythmia in last 6 months 8.Patient having systemic illness necessitating long term drug treatment like TB, carcinoma, endocrine disorders, concurrent major liver or renal disorders, psychological disorders, neurological disorders like epilepsy, meningitis, stroke etc.
- •9.Patients who have completed participation in any other clinical trial during the past 6 months 10.Patient having pulmonary diseases other than asthma 11.Patient having SPO2 less than 90% 12.Emergency patients requiring O2 inhalation.
结局指标
主要结局
Changes in subjective criterias;
时间窗: Treatment period – 3 months | Follow up period – on every 15th day
1.Asthma Control Test
时间窗: Treatment period – 3 months | Follow up period – on every 15th day
2.Reduction signs and symptoms of disease. The main signs and symptoms in study are as follows;
时间窗: Treatment period – 3 months | Follow up period – on every 15th day
Frequency of shwasa vega (frequency of breathing difficulty attacks)
时间窗: Treatment period – 3 months | Follow up period – on every 15th day
Duration of attack
时间窗: Treatment period – 3 months | Follow up period – on every 15th day
Kasam (cough)
时间窗: Treatment period – 3 months | Follow up period – on every 15th day
Kapha Nishthivanam (Expectoration)
时间窗: Treatment period – 3 months | Follow up period – on every 15th day
Rudhho Ghur-ghurakam (Wheezing)
时间窗: Treatment period – 3 months | Follow up period – on every 15th day
Urashoola/Parshvashoola (Pain at the chest region)
时间窗: Treatment period – 3 months | Follow up period – on every 15th day
次要结局
- Changes in following objective criterias;(1.Pulmonary function test- Spirometry)
研究者
Dr Sruthi K
Banaras Hindu University