A randomised controlled clinical trial to evaluate the efficacy of Rasanjanadi Lepa in mangament Of Nadi Vrana (Pilonidal Sinus)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Wound dimension
研究概览
简要总结
This study is Randomised ,Parallel group, active controlled trial to evaluate the safety and efficacy of Rasanjanadi lepa, in 172 patient aged between 16 to 45 years , over a period of 18 months. The patient will be of 21 days . During the trial assessment will be done on 0th , 7th, 14th, 21th, 28th days . After trial , follow up will be done after 43rd , 58th, 73rd, & 88th day after cessation of procedure.
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
- 16.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group of patient 16 to 45 years.
- •Patient diagnosed with Pilonidal Sinus & Abscess as per diagnostic criteria .
- •Patient capable of reading , completing, and assigning the consent from participating in the study.
排除标准
- •Presenting with dry & hard ulcer Presenting with Vatadhik Lakshan pregnant and lactating women Addiction to drugs and alcohol Abnormal bleeding from the wound using drugs that affect wound healing such as corticosteroids Using antibiotics prior to surgical intervention Not continuing the proposed treatment until the end of the study or request to leave the study History of severe allergy or anaphylactic shock caused by similar treatment Patient who has undergone organ transpiration Known case of connective tissue disease Known allergies to herbal drugs.
结局指标
主要结局
Wound dimension
时间窗: 21 days
Depth of wound
时间窗: 21 days
Wound excaudate quantity
时间窗: 21 days
Improvement in other symptoms or Pilonidal Sinus
时间窗: 21 days
Bacterial load by culture & sensitivity test
时间窗: 21 days
CRP
时间窗: 21 days
Time period
时间窗: 21 days
Wound volumetry
时间窗: 21 days
次要结局
- Improvement in other symptoms like pain(After analysing all the parameters the result will be assessed on the basis of symptomatic relief and improvement.)
研究者
Dr Sarvagya Pathak
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre , Gangoh-247341.