A clinical evaluation of analgesic effect of Vednasthapan Vati and Vednasthapan ointment in the management of post operative fissure in ano pain
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Relief in the post operative fissure in ano pain
研究概览
简要总结
The trial will be initiated with the aim & objective of evaluating the significance of the Vedna Shamak effect of Vednasthapan Vati clinically orally and Vednasthapan ointment local application upon post-operative fissure wound in the management of pain in the anal region
In this study total of 50 patients will be enrolled in a single-arm group
All 50 patients will be managed with Vednasthapan Vati 500mg orally with lukewarm water twice a day after a meal and the local application of Vednasthapan ointment 1g upon the post-operative fissure in the anal region wound once a day for 28 days from the first postoperative day
Each patient will be observed for changes in the intensity and duration of pain every 7th day continuously for 28 days from the first day after post operation
The same shall be recorded in the clinical Proforma case sheets for the study
A total of two follow-ups every 14th days after the trial up to 28 days will be taken
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Operated Patients with fissures in the ano complaining of pain in the anal region.
排除标准
- •Patients suffering from other systemic and metabolic diseases like Diabetes mellitus, tuberculosis, AIDS, Hepatitis, Anaemia, Chronic renal failure, and Uncontrolled Hypertension Patients operated for fissures in ano along with fistula, piles, and other ano rectal diseases Patients Having carcinoma of the rectum and carcinoma of the anal canal.
结局指标
主要结局
Relief in the post operative fissure in ano pain
时间窗: Till 28 days from the day of enrollment
次要结局
- Improve quality of life of the patient & research alternative analgesic ayurvedic drug with minimal side effects(After 56 days from the day of enrollment)