跳至主要内容
临床试验/CTRI/2024/09/074025
CTRI/2024/09/074025尚未招募2/3 期

Randomized controlled clinical trial to evaluate the efficacy of Yava kalka lepa in Dushta vrana(Non-healing wound).

Dr Shah Nausheen Firdose Hafiz Abdul Azeem1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年10月1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
92
试验地点
1
主要终点
To study the effect of Yava kalka on Dushta vrana Non healing wound like decrease in size,smell, discharge.

研究概览

简要总结

·         The Aim of Ayurveda is “Swasthasya swasth rakshanam  {to promote and protect the health of healthy person} and Aturasya vikar prashaman {to treat the diseased one}.

·         Shalya is the branch of Ayurveda dealing with Grass, Wound, Stone, Dust,Iron, Soil,Bone, Hair,Nail,Pus discharge,Infected wound,Foreign body,Dead fetus removal and dealing with Yantra ,Shastra karm Kshar Agnikarm therapies and to observe and asess and treat Aam Pachyaman and Pakwa awastha of Vrana is called Shalya tantra**.**

·         As it is clear by Shalya tantra definition Vrana is important part of it

·         Detailed discription of types of Vrana there explaination and treatment has been explained very briefly in dwi-vraniya adhyay of Chikitsa sthan of Sushrut samhita.

In Dwi vraniya adhyay of Sushrut samhita treatment of wound is given by Shashti upkramas.

·         Vrana means Spliting or tearing of body (causing discontinuity of skin and other tissues under it).as per sushruta samhita chikitsa sthan chapter 1 verse 6.it here Acharya Sushruta also explained  Shashti upakramas(i.e 60 management skills of wound ) in which Sushrut acharya explained the lepan karm also.

·         In this Shashti upkaram 29th karm is kalk application for Shodhan and Ropan of vrana

“In case of Wound of which slough is removed which are located in muscles and do not heal ,healing paste of Sesamum mixed with Honey should be applied.”

After that ,Sushruta Acharya mentioned that some scholars says paste of barely similar to that of Sesamum .it pacifies the unripe and ripen the semi ripe ,ruptures the ripened one and cleanses and heals the ruptured Wound**.**

·         In other context acharya Charak also explained in 25th chapter of chikitsa sthan

The wound which are painful hard stiff and without discharge should be pasted frequently  with barely powder mixed with ghrita .

WOUND

The definition of a Wound is damage to the integrity of biological tissue, including skin, mucous membranes, and organ tissues.

Non-healing Wound

A wound that does not heal in an orderly set of stages and in a predictable amount of time

Signs of Non-healing Wound

1.      Foul Odor

2.      Smelling and Thick Discharge

3.      Swelling or Redness

4.      Fever

5.      Hot Skin

·      Rationale of study :

·         The Prevalence of wounds is 15.03 per 1000. The Prevalences of Acute and Chronic wounds were 10.55 and 4.48 per 1000 of the Population respectively

·         Barley production is on very large amount in India so we can make cheapest wound care product from it India ranks 22nd in Barley production worldwide.

·         We need more Ayurveda local drug applications on wound which should be Cheap,  Non- invasive, Not causing any side effect, Easily available  to all Socio-economic classes.

·         To cope up with other pathies it is need of the hour for Ayurveda to make evidence based medicine in such diseases for universal acquiescence .

·         And to prove valuable hidden treasures of Ayurveda literature Samhitas as source  of evidance based research in Samhita kaal.

·         Inadequate and inappropriate treatment of acute wounds is the commonest cause of chronic wounds.

·         The other major area of concern for wound care physicians is a limited knowledge of the physiological processes involved in wound healing.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
17.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed cases of Dushta vrana.
  • Patients of age group 17to
  • Vrana of size 50x50x10 mm not more then it.
  • Patients irrespective of sex, religion, socioeconomic status, profession will be selected.

排除标准

  • Asadhya vrana .
  • Dushta vrana with no any co-morbidity along.
  • Patients having Tropical Ulcers and Ulcers due to burn and Animal bite.
  • Wound size more than 50x50x10mm.
  • Not less than 17 yr and more than 60 yrs.
  • • Withdrawal criteria 1) During course of study if any serious condition occurs or if any adverse event requires urgent treatment OR withdrawal criteria 2) If patient not willing to continue 3) Patients with irregular follow up.

结局指标

主要结局

To study the effect of Yava kalka on Dushta vrana Non healing wound like decrease in size,smell, discharge.

时间窗: assesment will be done on base line and on 1st ,7th ,14th, 28th day of application

次要结局

  • To study diffrence between efficacy of Yava kalka & Tila kalka in Dushtavrana size smell & discharge with comparing rate of healing & cost .watch change in color & shape after treatment(to asses above criteria at base line & on 1st,7th,14th,28th day of local application)

研究者

发起方
Dr Shah Nausheen Firdose Hafiz Abdul Azeem
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shah Nausheen Firdose Hafiz Abdul Azeem

M.U.H.S Nashik.

研究点 (1)

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