A randomized open label controlled clinical study to evaluate the efficacy of Sphatika Guda Varti in the management of Raktaarshas with special reference to first and second degree bleeding Hemorrhoids.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Significant change in the Rakta Srava
研究概览
简要总结
This study have been taken up to evaluate the efficacy of Sphatika Guda Varti in the management of Rakta Arshas with special reference to 1st and 2nddegree bleeding Hemorrhoids.
Comparison with Sphatika Jala Per Rectal Instillation.
HYPOTHESIS
1.NULL HYPOTHESIS:
H0:
There is no significant difference between the efficacy of Sphatika Guda Varti and Sphatika Jala Per Rectal instillation in the management ofRakta Arshas with special reference to 1st and 2nd degree bleeding hemorrhoids.
2.ALTERNATE HYPOTHESIS:
H1:
The efficacy of Sphatika Guda Varti is better than Sphatika Jala Per Rectal instillation in the management of Rakta Arshas with special reference to 1st and 2nd degree bleeding hemorrhoids.
H2:
The efficacy of Sphatika Jala Per Rectal instillation is better than Sphatika Guda Varti in the management of Rakta Arshas with special reference to 1st and 2nd degree bleeding hemorrhoids.
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
- 21.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects aged between 21–70 years, irrespective of gender, religion, occupation, socio-economic status and educational status.
- •2.Subjects who fulfills the diagnostic criteria of 1st and 2nd degree bleeding internal hemorrhoids.
- •3.Subjects willing to give consent.
排除标准
- •1.Hemorrhoids associated with Rectal prolapse.
- •2.Thrombosed pile mass.
- •3.Hemorrhoids associated with Fistula-in-Ano.
- •4.Subject with other systemic illness like Tuberculosis, Ulcerative colitis and Crohn’s disease.
- •5.Subjects With HIV, HBsAg. 6.Subjects with Autoimmune diseases .
- •7.Subjects who are Pregnant and lactating.
- •8.Subjects not willing to give consent.
- •9.Subjects who are under antiplatelet and anticoagulant medication.
结局指标
主要结局
Significant change in the Rakta Srava
时间窗: 1st,3rd,5th,7th Day
次要结局
- Reduced size of internal hemorrhoidal masses & Vibandha(7th & 14th Day.)
研究者
Dr Sowjanya K B
Sri Sri College of Ayurvedic Science and Research