跳至主要内容
临床试验/CTRI/2024/10/075034
CTRI/2024/10/075034尚未招募3 期

Clinical evaluation of Jaloukavacharana in Dushta Vrana(Non-Healing Ulcer)

CCRAS1 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2024年12月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
228
试验地点
1
主要终点
1. Healing effect of Jaloukavacharana in Non healing ulcer assessed through ulcer area measurement using digital planimetry.

研究概览

简要总结

The aim of the study is to assess the healing effect of Jaloukavacharana in non healing ulcer. The study has three objectives. The objective is to assess the healing effect of Jaloukavacharana in Non Healing Ulcer by using Digital Planimetry, Transcutaneous oxygen tension measurement and PUSH Score.

The study participants diagnosed with Non Healing Ulcer will be admitted in Govt.Ayurveda College Hospital Tripunithura for conduct of trial. The patients will be grouped into two A and B. Both groups will have cleaning and dressing, internal medication. Cleaning of the wound will be done with triphala kashaya and dressing will be done with Jathyadi taila daily upto 21days. Internally punarnavadi kashaya will be given for 21 days in Non Healing Ulcer patients. In addition to above treatment Group A will have Jaloukavacharana on every 3rd day upto 21 days, total 8 sittings. The Symptoms and signs are recorded by following standard method and both groups are compared and results will be statistically analysed.

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
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • • Venous ulcer • Arterial ulcer • Diabetic foot ulcer • Subjects within the age group 20-70 • Wound size of 10x10 CM area.

排除标准

  • • Tuberculosis • Malignancy • Burns • Gangrene • Traumatic ulcer (within 7 days).

结局指标

主要结局

1. Healing effect of Jaloukavacharana in Non healing ulcer assessed through ulcer area measurement using digital planimetry.

时间窗: Assessment will be done on 0th day, 3rd day, 6th day, 9th day, 12th day, 15th day, 18th day, 21st day, 24th day, 27th day and 28th day. The study period is 28 days and follow up period is 160 days

2.The effect in improvement of circulation in Non healing ulcer by Jaloukavacharana, will be assessed through Transcutaneous oxygen tension measurement.

时间窗: Assessment will be done on 0th day, 3rd day, 6th day, 9th day, 12th day, 15th day, 18th day, 21st day, 24th day, 27th day and 28th day. The study period is 28 days and follow up period is 160 days

3. Healing effect of Jaloukavacharana in Non healing ulcer, will be assessed through Pressure Ulcer Scale for Healing.

时间窗: Assessment will be done on 0th day, 3rd day, 6th day, 9th day, 12th day, 15th day, 18th day, 21st day, 24th day, 27th day and 28th day. The study period is 28 days and follow up period is 160 days

次要结局

  • 1. Improvement of circulation in Non healing ulcer affected area by Jaloukavacharana assessed through Transcutaneous oxygen tension measurement(2.Healing effect of Jaloukavacharana in Non healing ulcer assessed through Pressure Ulcer Scale for Healing)

研究者

发起方
CCRAS
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr M M Abdul Shukkoor

Govt Ayurveda College Hospital Tripiunithura

研究点 (1)

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