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临床试验/CTRI/2024/06/068430
CTRI/2024/06/068430尚未招募2/3 期

A Randomized, Standard Controlled Clinical Trial Of Unani Formulation (Kundur, Aelwa, Dam-ul- akhawain, Anzaroot) In Non healing ulcers

National Institute of Unani Medicine1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年6月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
44
试验地点
1
主要终点
1) 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-healing ulcers are those that do not heal after 6 weeks of conservative therapy.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.

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, skin grafting, Gene therapy, Stem cell therapy, Shock wave, VAC (Vacuum aided closure), and surgicalmanagementasangioplastyandreconstructivesurgeryetc3.; are available and costly treatments for non-healing ulcers.

OBJECTIVE OF STUDY:

To Assess the efficacy of the Unani formulation (Kundur, Aelwa, Dam-ul-Akhawain, Anzaroot) 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.
  • Wagner’s grading 0,1and 2 ulcers.

排除标准

  • Gangrenous and Malignant ulcers.
  • Pregnant and lactating women.
  • Patient with any severe systemic disease.

结局指标

主要结局

1) Discharge

时间窗: Alternate day starting from 0th day

2) Pain (Yes/No)

时间窗: Alternate day starting from 0th day

3) No.of wound

时间窗: Alternate day starting from 0th day

次要结局

  • VAS scoring of pain.(•Wagner’s gradingofulcer.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

ANAM AFSAR

National Institute Of Unani Medicine Banglore

研究点 (1)

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