Randomised Controlled Clinical Study of Application of Yava kalka churna with ghrita in comparison with application of Povidone Iodine ointment in the management of shuddha vrana
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- To compare the wound healing property of yava kalka churna ghrita with povidone-iodine
研究概览
简要总结
Randomised Controlled Clinical Study of Application of Yava Kalka Churna with Ghrita in Comparison with Application of Povidone-Iodine Ointment in the Management of Shuddha Vrana.
Objective:To evaluate the efficacy of a traditional Ayurvedic formulation (Yava Kalka Churna with Ghrita) versus a modern antiseptic (Povidone-Iodine ointment) in treating Shuddha Vrana (clean wounds).
Methodology:
Study Design: Randomized, open-label, controlled clinical trial.
Sample Size: 88 participants, divided into two groups (44 each).
Group A (Trial): Treated with Yava Kalka Churna + Ghrita.
Group B (Control): Treated with Povidone-Iodine ointment.
Duration: 7 days, with follow-ups on Day 3 and Day 7.
Parameters: Wound size, color, pain, healing duration, burning sensation.
Evaluation: Subjective and objective clinical parameters were used, supported by statistical tests (t-test, chi-square, etc.).
Hypotheses:Yava Kalka Churna with Ghrita is more/equally effective or not effective compared to Povidone-Iodine.
Ethics & Approvals:Approved by the Institutional Ethical Committee. Includes informed consent forms and protocol documentation.
Outcome:The study aims to provide evidence-based validation of Ayurvedic wound treatments and promote integration with modern medical practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Participants having Shuddha Vrana irrespective of sex age occupation 2 Fresh incised wounds,superficial wounds lacerated wounds within 24 hours will be selected 3 Uninfected wounds in process of healing will be selected 4 Non-infected Diabetic wound with healthy granulation BSLR less than 200mg per dl.
排除标准
- •1 Known case of Venous Tubercular Ischemic 1Tropical Neurogenic malignant ulcers 2 Infected wounds 3 Diabetic Wounds having discharge or slough BSL R more than 200 mg perdl 4 Participant suffering from HIV HbsAG 5 Wound having dimension more than 6cm.
结局指标
主要结局
To compare the wound healing property of yava kalka churna ghrita with povidone-iodine
时间窗: 1st follow up on 3rd day and then on 7th day
ointment.
时间窗: 1st follow up on 3rd day and then on 7th day
次要结局
- To study the adverse drug effect of Yava kalka churna with ghrita (if any).(1st follow up on 3rd day and then on 7th day)
研究者
Dr Gajanan Laxman Surkar
Tilak Ayurved Mahavidyalaya , Rasta Peth , Pune