A Randomized Comparative Clinical Study To Evaluate The Efficacy Of Changeri Ghrita Ointment And Kasisadi Taila Ointment In The Management Of Arsha (First And Second Degree Haemorrhoids).
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changeri Ghrita Ointment and Kasisadi Taila Ointment will have effect in symptomatic relief, i.e. Pain in ano, Itching in ano, Burning in ano, Per rectal bleeding, Mucous discharge in ano in Arsha (First and Second Degree of Haemorrhoids).
研究概览
简要总结
In a Randomised Comparative Clinical Study, 30 participants will be selected and equally divided into two groups. Trial Drug Group A Changeri Ghrita Ointment will be given for local application in ano and In Comparator Drug Group B Kasisadi Taila Ointment will be given for local application in ano 5 gm twice a day for 14 days. Along with in both groups internal medicine Erandbristha Haritaki Churna 5 gm H.S with warm milk for 14 days. Warm water sitz bath will be given in both groups Twice a day for 14 days. Follow-up will be taken every 7th day of treatment for up to one month. Assessment will be done with a case record form with criteria like Pain in ano, Itching in ano, Burning in ano, Mucous discharge in ano, Per rectal bleeding, and Degree of pile mass. Collected data will be analyzed statistically using suitable methods, and a conclusion will be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants age group between 18 years to 60 years.
- •Participants presenting with Signs and Symptoms of Arsha (first and second degree haemorrhoids).
- •Participants will be selected irrespective of their gender, caste, religion, and profession.
排除标准
- •Participants of age less than 18 years and more than 60 years of age.
- •Participants suffering from Any other anorectal conditions associated with haemorrhoids Except first and second degree haemorrhoids.
- •Participants suffering from Any malignancy.
- •Known case of comorbid conditions i.e. HTN, DM, Liver disease, Portal HTN, HIV and HBsAg Participants.
- •Pregnant lady and lactating lady.
- •Fissure-in-Ano, fistula-in-ano, Haemorrhoids with ulcerative colitis or Crohn s disease.
结局指标
主要结局
Changeri Ghrita Ointment and Kasisadi Taila Ointment will have effect in symptomatic relief, i.e. Pain in ano, Itching in ano, Burning in ano, Per rectal bleeding, Mucous discharge in ano in Arsha (First and Second Degree of Haemorrhoids).
时间窗: 7 days.
次要结局
- Changeri Ghrita Ointment And Kasisadi Taila Ointment will do shrinkage of pile mass.(14 days.)
研究者
Dr Sudipkumar Prakashbhai Modi
G. J. Patel Institute of Ayurvedic Studies and Research.