Effect of Bhallatakadi Modaka in the management of Raktarsha- A randomized clinical trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Decline in the Bleeding PR from baseline to 8 days from Baseline
研究概览
简要总结
RESEARCH****QUESTION: Is there any effect of Bhallataka Modaka in reducing bleeding in patients of Raktarsha compared to Bolabaddha rasa?
Groups: Two
Group A – Bhallatakadi Modaka as Internal Medicine – 2gms/day
Group B – Bolabadda Rasa as Internal Medicine – 2gms/day
Selection of Cases: - Raktarsha w.s.r to 1st and 2nd degree Haemorrhoids
**Inclusion Criteria:**Patients of either sex between 20-60 years of age group with 1st and 2nd degree Haemorrhoids.
Exclusion Criteria
• Thrombosed Haemorrhoids, Prolapsed Haemorrhoids.
• Haemorrhoids with other entities like Fissure in Ano, and Fistula in Ano.
• History of Systemic Illnesses like HTN, DM, Peptic ulcer, Inflammatory Bowel Diseases, HIV I & II, HBsAgreactive
Assessment Criteria
The following criteria will be used:
1. Bleeding during defaecation
2. Pain in relation to defecation
3. Constipation
4. Protrusion of pile mass
5. Mucus discharge
6. Itching at anus
Expected Outcome:
Decline in the Bleeding PR from baseline to 8 days from Baseline
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex between 20-60 years of age group with 1st and 2nd-degree Haemorrhoids.
排除标准
- •Thrombosed Haemorrhoids, Prolapsed Haemorrhoids.
- •Haemorrhoids with other entities like Fissure in Ano, and Fistula in Ano.
- •History of Systemic Illnesses like HTN, DM, Peptic ulcer, Inflammatory Bowel Diseases, HIV I & II, HBsAg reactive.
结局指标
主要结局
Decline in the Bleeding PR from baseline to 8 days from Baseline
时间窗: 8 days
次要结局
未报告次要终点
研究者
Sarojani Kuchanur
SGT University