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临床试验/CTRI/2025/03/082903
CTRI/2025/03/082903尚未招募不适用

A Randomized Comparative Clinical Study to Evaluate the Shodhana effect of Tilaabhayadhi Lepa and Nimbadi Kalka Lepa in the management of Dushta Vrana with special reference to Non healing ulcer

Dr K H M Bharathesh1 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31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Reduction in Pain(Vedana)

研究概览

简要总结

Acharya Sushruta defined Vrana as Gatra Vichoornana, which causes destruction and discoloration of body tissue.1 Dushta Vrana Lakshanas are Krishna, Rakta, Peeta, Shukla Varna, Putimamsa, Puyasrava, Atyartavedana, Dushtashonitasrava, Daha, Paka, Raga, Kandu, Shopha and Dheerghakaleena2.  Dushta Vrana can be correlated to non healing ulcer in allied science.

Ulcer is a break in the continuity of the covering epithelium, either skin or mucous membrane due to molecular death. Non healing ulcers are characterized by pain, discharge, itching, burning sensation and foul smell. Non healing ulcers include nonspecific ulcers like Traumatic ulcer, Arterial ulcer, Venous ulcer, Trophic ulcer, Infective ulcer, Diabetic ulcer and other.3 An ulcer is a major health problem and it affects nearly 6 million population worldwide. In India it is reported as 4.5 per 1000 population, the incidence of chronic ulcers is expected to increase as the population age increase.4

In modern science ulcer is managed by debridement, ulcer cleaning and dressing. Desloughing is done either mechanically or chemically. Mechanically by debridement. Hydrogen peroxide which releases nascent oxygen is used as chemical agent. Ulcer cleaning and dressing is done daily or twice daily or once in 2-3 days depending on the type of ulcer and type of dressing used.3

Acharya Sushruta has told various Shodana measures like Sharirika Shodana by Vamana, Virechana and Sthanika Shodana by Kashaya, Kalka, and Avachurana, etc. Lepa karma is one among Shashtiupakrama in which drugs of herbal, herbo-mineral or animal origin are used for Vrana Lepana. Lepa karma is an integral part of Shashtiupakrama which ensures the protection against the microbes and it act as Vranashodana by reducing Vedana and Srava.5

Acharya Chakradatta in the context of Bhagandara Chikitsa explained Tilaabhayadi lepa for Bhagandara and Dushtavrana. It contains drugs like Tila, Abhaya, Lodra, Nimba, Haridra, Daruharidra, Vacha, Kusta, Gruhadooma which possess Shodhana properties.6 Acharya Sushruta has mentioned about Nimbadi kalka lepa under Dvivruniya Chikitsa for the Vrana Shodhana which contains drugs like Nimba, Tila and Madhu.7

Here an attempt is made to evaluate and compare the Shodhana effect of Tilaabhayadi Lepa and Nimbadi kalka Lepa in Dushtavrana with special reference to Non healing ulcer.

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

  • Patients suffering from Dushta vrana in the age group between 18-70 years and irrespective of gender.
  • Patients of Nonspecific ulcers of Traumatic ulcer, Arterial ulcer, Venous ulcer, Trophic ulcer, Infective ulcer, Diabetic ulcer and other.

排除标准

  • Patients of non healing ulcer with Malignant and Gangrenous changes.
  • Patients with ulcer of Syphilitic ulcer, Tuberculosis ulcer, Marjolin ulcer, Bedsore ulcer and Leprosy.
  • Patients of uncontrolled diabetes mellitus.
  • RVD and HBsAg positive patients.
  • Pregnant and Lactating women.

结局指标

主要结局

Reduction in Pain(Vedana)

时间窗: At the duration of 7days

Reduction in Odour(Gandha)

时间窗: At the duration of 7days

Reduction in Itching(Kandu)

时间窗: At the duration of 7days

次要结局

  • Reduction in Discharge(Srava)(At the duration of 7days)

研究者

发起方
Dr K H M Bharathesh
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr K H M Bharathesh

BVVS Ayurved Medical College and Hospital Bagalkot

研究点 (1)

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