Comparative Clinical Study on the effectiveness of Kakubhadi Malahara on Episiotomy Wound
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Healing of Episiotomy wound.
研究概览
简要总结
This study is open label double arm clinical trail to evaluate the possible effect of Kakubhadi Malahara on the wound activity of Episiotomy wound and to compare its possible effect with Povidone ointment.
This study will be conducted at In-Patient Department of Prasuti Tantra Evum Stree Roga at Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital, Hassan, Karnataka.
Method- Sample will divided into two group.
Group A (Trial Intervention)- Kakubhadi Malahara
Group B (Control Intervention)- Povidone ointment
Frequency- Twice a day
Duration- 7 days
Dose- Sufficient quantity
Assessment of result will be done before and after the treatment on the basis of following subjective and objective parameters.
Subjective Parameters- Perineal pain, tenderness, difficulty in walking, difficulty in sitting, difficulty in defecation.
Objective Parameters- Perineal healing, the standard REEDA SCALE will be used.
R- Redness
O- Oedema
E- Ecchymosis,
D- Discharge
A- Approximation of the wound edges.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •All primi and multi gravida with Episiotomy wound.
- •Ready to sign the informed and written bilingual consent form.
- •Fulfilling the diagnostic criteria.
排除标准
- •Diagnosed case of severe anaemia.
- •Tested positive with HIV, VDRL, HBsAG.
- •Diagnosed with Skin disorder.
- •History of impaired wound healing and repair.
- •3rd and 4th degree laceration of the perineum.
结局指标
主要结局
Healing of Episiotomy wound.
时间窗: Interim Assessment- Day 3 | 1st Follow up- Day 15 | 2nd Follow up-Day 30
次要结局
- Reduction of pain.(Interim Assessment- Day 3)
研究者
Dr Nidhisha Singla
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, Hassan