A Comparative Pharmaceutico – Analytical Study of Kshara and Lavana of Kantakari (Solanum virginianum L.) and to Evaluate their Clinical Efficacy as an Add-on Therapy in Bronchial Ashthma
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Relief in Dyspnoea and Cough
研究概览
简要总结
The clinical study was conducted following approval from the institutional ethics committee (GAC/VDD/IEC/94/2024) and registered with the clinical trial registry of India CTRI/2024/09/073678, registered on 10/09/2024. This was an open labelled parallel arm randomized clinical trial in Bronchial Asthma. The patient was diagnosed based on the presence of one or more symptoms specified in GINA. The effect of the therapy was evaluated using subjective criteria such as Dyspnoea, Cough, Wheezing and Chest tightness and Objective criteria such as Dyspnoea, Cough, FEV1, PEFR, BHT and ACT after treatment. Symptoms was assess using scoring pattern. 54 subjects were randomized into 2 groups: Group A : Kantakari Kshara (KK) with conventional medicine and Group B: Kantakari Lavana (KL) with conventional medicine. 27 patients enrolled in each group among them 2 patients were dropped out in each group, remaining 25 patients in each group completed their treatment. KK and KL were administered in 500 mg BD dose with warm water after breakfast and dinner for 4 week. After 4 weeks follow up was done. After statistical analysis highly significant (p<0.001) improvement was found in both groups in all parameters. Among subjective criteria Dyspnoea improved by 71.23% Group A and 69% in Group B, cough by 82.19% and 83%, wheezing by 77.98% and 91.2% and chest tightness by 83% and 76% respectivelly. Among objective parameters Dyspnoea improved by 52.66% and 54.66%, Cough by 72.81% and 75.83%, FEV1 by 18.08% and 15.34%, PEFR by 29.35% and 31%, BHT by 46.73% and 76.98% and ACT by 24.19% and 34.28% in Group A and Group B respectivelly. No statistically significant difference (p>0.05) was observed in both groups. No any adverse drug event was observed during Ayurvedic medicine used with conventional therapy of patient in Bronchial Asthma as an add on therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Asthma since more than one year.
- •Patients on stable medication for one month.
- •Patient with partially or uncontrolled symptoms and/or FEV1 50-80% of predicted.
排除标准
- •Age below 18 years and above 70 years.
- •Uncontrolled hypertension, diabetes or chronic systemic diseases
- •Cardiac diseases (IHD, CCF, DCM, RHD etc.)
- •Patient with respiratory infections in past one month.
- •Exacerbation in past one month
- •Patient with active tuberculosis, HIV etc
- •Any malignancy 10.Presence of other pulmonary disease like emphysema, cystic fibrosis etc.
结局指标
主要结局
Relief in Dyspnoea and Cough
时间窗: 15 days
次要结局
- Relief in all symptoms(28 days)
研究者
Dr Jeel N Patel
Government Ayurved College and Hospital, Vadodara