跳至主要内容
临床试验/CTRI/2025/03/081897
CTRI/2025/03/081897尚未招募2/3 期

A Comparative Clinical Study Of Unani Formulation (Aelwa,Murmakki,Anzaroot,Kundur) and povidone Iodine Betadine 5 Percent In The Management Of Non Healing Ulcer A Randomised Control Study.

National Institute Of Medicine1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月17日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Discharge

研究概览

简要总结

An ulcer is a break in the continuity of the covering epithelium either skin or mucous membrane due to molecular death of the surface epithelium or its traumatic removal.1Non-healingulcers are those that do not heal after 6 weeks of conservativetherapy.2 Chronic non-healing ulcers are a major health issue that affects an estimated 2-6 million people in the United States alone, with global prevalence ranging from 1.9 to 13.1%.3 Leg ulcers affect approximately 1-2% of the population.

Chronic venous insufficiency contributes to approximately 60% of all chronic leg ulcers.4 The prevalence of non-healing venous ulcers ranges between 1 and 2%, accounting for nearly 75-80% of all vascular ulcers.3

Arterial ulcers are the most common ulcer in the age group of 41 to 50 years. Atherosclerosis is the commoner association with arterial ulcer constituting 58.4% and other association with arterial ulcer thromboangitis obliterans accounting for 44.6%.5

Globally 463 million people are living with diabetes; The life time risk of a person with diabetes having foot ulcer has been reported to be as high as 25%. In India the numbers of diabetic foot patients are increasing in both urban and rural areas with 85% of amputation preceded by foot ulcer. In India approximately 100,000 legs are amputated every year.6

The management of non-healing ulcers comprises, the treatment of the underlying cause, wound cleansing and dressing, personal hygiene, infection management, and wound closure.3 Many chronic ulcers refuse to heal or linger for months/years despite therapy, and/or relapse after healing, necessitating the use of advanced wound care therapies such as Hyperbaric Oxygen therapy, skingrafting, Gene therapy, Stem cell therapy, Shock wave, VAC (Vacuum aided closure), and surgical management as angioplasty and reconstructive surgery etc3 are available and costly treatments for non-healing ulcers.

OBJECTIVE OF STUDY:

To Assess the efficacy of the Unani formulation (Aelwa, MurMakki, Anzaroot, Kundur) in comparison to Povidone iodine 5%ointment.

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 70.00 Year(s)(—)
性别
All

入选标准

  • All genders Ulcers Not Healing For More Than 6 weeks.
  • Wagners Grading 0 1 and 2 Ulcers.
  • Patient Age group 18 70 years.

排除标准

  • Gangrenous andMalignantulcers.
  • Pregnantand Lactatingwomen.
  • Patientwith anyseveresystemic disease.

结局指标

主要结局

Discharge

时间窗: alternate day dressing starting from 0th Day,15th Day,30th Day,45th Day

Pain (Yes/No)

时间窗: alternate day dressing starting from 0th Day,15th Day,30th Day,45th Day

No.of wound

时间窗: alternate day dressing starting from 0th Day,15th Day,30th Day,45th Day

次要结局

  • VAS Scoring Of Pain(Wagners Grading Of Ulcer)

研究者

发起方
National Institute Of Medicine
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Ramlah Hussain

Ilmul Jarahat

研究点 (1)

Loading locations...

相似试验