A Clinical Study on the Evaluation of Haridra (Curcuma longa Linn.) Loaded Niosomal Gel for Episiotomy Wound Healing with Special Reference to Vrana Ropana.
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
- to assess the rate and quality of wound healing using Haridra loaded niosomal gel
研究概览
简要总结
This study is single arm single centre pilot study to evaluate the efficacy of Haridra (Curcuma longa Linn) Loaded Niosomal Gel for 18 months in 30 patients for Episiotomy wound healing with special refrence to Vrana Ropana
The primary outcomes measures will be to assess the rate and quality of wound healing using Haridra loaded niosomal gel and to evaluate changes in Redness, Ecchymosis, Discharge , Approximatiion score, and pain (VAS scale) during the healing process
The secondary outcomes measures will be based on to assess the antimicrobial effects of Haridra loaded Niosomal gel
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
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •.women age between 18 to 35 who have undergoes normal vaginal delivery with mediolateral episiotomy .primiparous women .Healthy term pregnancy .REEDA score equivalent or less than 4 .who can attain hospital for a regular follow up .patients who give written informed consent for the clinical trial .singleton vaginal delivery.
排除标准
- •.women of age less than 18 years and more than 35 years .episiotomy wound infection already present at day 1 .women with intrumental deliveries (foreceps or vaccum assisted) .multiparous women .known case of diabetes mellitus,hypertension , or immunocompromised status .known allergy ,hypersensitivity .post partum complications.
结局指标
主要结局
to assess the rate and quality of wound healing using Haridra loaded niosomal gel
时间窗: Day 1(baseline) ,day 7,day 15 and with additional observation at day 21 and day 30 to evaluate sustained healing and late occuring effect
.to evaluate changes in redness,oedema ,ecchymosis, discharge ,approximation score, and pain (VAS scale) during the healing process
时间窗: Day 1(baseline) ,day 7,day 15 and with additional observation at day 21 and day 30 to evaluate sustained healing and late occuring effect
次要结局
- to assess the antimicrobial effect of Haridra loaded niosomal gel(Day 1 (baseline), day 7, day 15 and with additional observation at day 21, and day 30 to evaluate sustained healing and late occuring effect)
研究者
Dr Rubab Chaudhary
Kunwar shekhar vijendra ayurved medical college and research centre, Shobhit university ,Gangoh