A double arm open label comparative clinical trial on Marichyadi Syrup and Marichyadi Lozenges dosage forms for managing Kasa with special reference Acute Bronchitis in children.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
The present study is a double-arm, open-label, comparative clinical trial undertaken to evaluate the efficacy of Marichyadi Syrup and Marichyadi Lozenges in the management of Kasa, with special reference to Acute Bronchitis in children. In Ayurveda, Kasa is considered a primary disorder of the Pranavaha Srotas and closely correlates with acute bronchitis described in modern medicine. Cough is one of the most common presenting complaints in pediatric practice and, if persistent, may interfere with the normal growth and development of children. Conventional antitussive therapies are often associated with adverse effects and limited acceptability in children, highlighting the need for safer alternatives.
A total of 60 pediatric patients aged 6–15 years will be randomly divided into two groups. Group A will receive Marichyadi Syrup at a dose of 0.8 ml/kg/day, while Group B will receive Marichyadi Lozenges at 50 mg/kg/day, administered for 14 days with 4 follow-up with medicine and one followup without medicine up to 21 days. Both formulations contain Maricha, Pippali, Dadima Twaka, Guda, and Yavakshara, which possess Kasahara, Kaphavata-shamaka, anti-inflammatory, antimicrobial, and immunomodulatory actions.
Clinical assessment will be based on subjective parameters such as cough severity, sputum consistency, wheezing, fever, hoarseness of voice, and dryness of mouth, along with objective investigations including CBC, AEC, and chest X-ray. Statistical analysis will be carried out using paired and unpaired t-tests to compare therapeutic efficacy. This study aims to scientifically validate effective, safe, and child-friendly Ayurvedic dosage forms for pediatric acute bronchitis.
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
- 6.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects irrespective of gender, religion, socioeconomic status and between the age group of 6-15 years.
- •Acute kasa from day 1 to 3 weeks with or without presence of mucus will be enrolled.
- •Mild fever (37.5 degree celcius to 38.5 degree celcius or 99.5 degree fahrenheit to 101.4 degree fahrenheit should will be enrolled.
排除标准
- •Patient below age of 6 years and above 15 years should be excluded from the study.
- •High grade fever above 38.5 degree celcius or 101.4 degree fahrenheit should be excluded.
- •Patient having Kasa as upadrava or anubandha lakshana (complication) of other systemic disease.
- •Patient suffering from any severe disease of lower respiratory tract infection.
- •Any chronic illness disease of respiratory system eg.
- •TB, Chronic lung disease, Bronchiectasis, Pleurisy which is known.
- •Serious cardiovascular, cerebrovascular, renal and liver disease or severe illness.
- •Patient suffering from any systemic disorder( like Diabetes Mellitus).
- •Children with any congenital abnormality.
- •During course of treatment if the subject develops any acute illness requiring acute managem ent, such patients will be excluded out of the study and continued with conventional treatment.
- •Patients/parents who are not willing to continue the treatment.
研究者
Dr Suniti Kumari
State Ayurvedic college and hospital Lucknow