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临床试验/CTRI/2025/07/089951
CTRI/2025/07/089951尚未招募Phase 3 4

An open label single arm clinical study to evaluate the Sharapunkha lepa in the management of Sadyovrana.

Dr Ashok Kumar S1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月10日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Fast healing of wound

研究概览

简要总结

In ayurveda Vrana is defined as “Vrana Gaatra Vichurnane Vranayateeti Vrana|”1 "Gaatra" means Tissue (body tissue or part of body), "Vichurnane" means destruction, break, rupture and discontinuity of the body tissue. "The destruction / break/ rupture/ discontinuity of the body tissues are called vrana"/wound.2 Injury is the adverse effect of a physical force upon a person and all force involved in injuries is mechanical3. The incidence of wound, trauma is very large globally and a large share of economy is spent annually for the prevention of complications and management of the wound patients.4 Wound healing is the process of repair that follows injury to the skin and other soft tissues.5 There are three stages of wound healing:- Inflammation, Proliferation and Remodeling (Maturation phase).6 A vast description of Vrana and Vranaropaka yogas has been explained in Ayurveda thousands of years ago. Vrana mainly classified into two types7 1. Nijavrana. 2. Agantujavrana. Sadyovrana is mentioned under Agantujavrana. Acharya Sushrutha has given a detailed description of Vrana and its management elaborately described in Susrutha Samhitha, that includes ShastiUpakrama in which, Alepa8 is the 2ndShastiUpakrama. For treatment of Sadyovrana, Chakradatta has mentioned, Sharapunkha lepa, which contains Sharapunkha and Madhu that heals all types of vrana.9 The Sharapunkha drug is also mentioned by Bhavaprakasha in Guduchayadi varga10, Priya nigantu in shatapushpa varga11 and Indian materia medica mentions Sharapunkha (Teprosia purpurea) drug having wound healing property/ Vranaropana.12 For the treatment of Sadyovrana, Acharya Sushrutha has explained application of Madhu (Honey) and Go-gritha for sandanartha.13 Vagbhata acharya described application of Madhu and Grutha after surgical procedure for the Post-operative wounds.14Many therapeutic properties have been attributed to honey including antibacterial activity and the ability to promote healing.15 Both the drugs are easily available and preparation method is easy, economical and can be done in OPD basis. Analyzing their efficacy can be especially relevant and beneficial for communities with limited access to advanced medical resources and it also shedlight on potential synergistic effects. Hence it has been planned to study Sharapunkha lepa clinically on the patients of Sadyovrana.

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

入选标准

  • Subjects irrespective of age, sex and occupation.
  • Sadyovrana upto deep fascia.

排除标准

  • Sadyovrana with injury to major blood vessels, nerves or vital organs.
  • Sadyovrana breaching deep fascia.
  • Wound associated with Fracture.
  • Wound that require suture.
  • The subjects having Sadyovrana with complications like Marmaghata.
  • Medico-legal cases.
  • Subjects suffering from complicated systemic disorders that which interfere in the line of treatment.
  • Subjects of known cases like Malignancy, Gangrene, Leprosy, TB wound, HIV, Hepatitis-B.

结局指标

主要结局

Fast healing of wound

时间窗: 10 days

次要结局

  • Quick Healthy granulation tissue formation(10 days)

研究者

发起方
Dr Ashok Kumar S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ashok Kumar S

Ashwini Ayurvedic Medical College and Research centre

研究点 (1)

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