CTRI/2023/11/060069尚未招募Phase 3 4
Evaluation of comparative efficacy of Healature spray versus Oxum spray in the management of Fistulectomy wound(RCT)
Dr Dhruv Bhadreshbhai Modi1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年1月1日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Fistulectomy wound healing
研究概览
简要总结
The volunteers will be informed about the study protocol. willing participant will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod(H), Wardha and CTRI registration will be done. After selection ,each participant will be tested individually and selected according to selection criteria. they will be divided into two groups as the trial is a parallel group, randomized, open clinical, standard controlled trial. it will include a 16 days treatment period and follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of both the sexes in between the age group of 18 to 60 years.
- •Patients irrespective of gender, religion, occupation and economic status.
- •Complete fistulectomy wounds of length 1-3 cm will be included in this study.
- •Patients with controlled hypertension and diabetes mellitus.
排除标准
- •Patients having Fistula in ano secondary to Ulcerative colitis, Syphilis, Crohn’s disease, Tuberculosis and malignancy of rectum and anal canal.
- •Pregnant females HIV& HbsAg positive patients Skin diseases.
结局指标
主要结局
Fistulectomy wound healing
时间窗: 14 days
次要结局
- relief in pain, reduces itching(14 days)
研究者
研究点 (1)
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