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临床试验/CTRI/2024/11/077484
CTRI/2024/11/077484尚未招募3 期

A Randomized Controlled Clinical Study Of Madhuyukta Sharpunkha Kalka Lepa With Jaloukavacharan In The Management Of Dushta Vrana With Special Reference To Infected Wound.

Dr Monica santosh Patil1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年12月9日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
1)To compare the effectiveness of Madhuyukta Sharpunkha Lepa

研究概览

简要总结

Title :-

"Randomised Controlled Clinical Study Of Madhuyukta Sharpunkha Kalka Lepa With Jalaukavcharan In The Management Of Dushta Vrana With Special Reference To Infected Wound."

AIM -

To Evaluate the efficacy of Madhuyukta Sharpunkha Kalka Lepa With Jalaukavcharan in the treatment of Dushta vrana w.s.r. to infected wound.

  1. Primary

Objectives :-

To compare the effectiveness of Madhuyukta Sharpunkha Lepa(vranaropak Lepa )and Jaloukavcharan with Metrogyl-P ointment in Infected wound.

Other Objectives:-

1)To propose an alternative easily available herbal preparation in the management of Dushtavrana.

2)To assess the treatment duration of Dushta Vrana( Infected wound)using study drug topically.

3)To find out therapeutic measures(Jalaukavacharan) that would be useful in the management of ulcer healing which will be cost effectiveas well as safe (having no side effects).

3)To study the review of literature of Dushta vrana and infected wound.

Methodology :-

Study design:

Randomized control study

Study settings (Location):

70 patients fulfilling the criteria and attending the OPD/IPD of Shalyatantra department of the Hospital will be selected for the present study irrespective of age, sex, religion etc.

Duration of study:18 months

Time of application;

VranaRopakLepa(Madhyukta Sharpunkha) will be applied daily at morning session until wound heals (if not maximum upto 45 days). Jalouka will be applied with two settings in a week or as per wound condition.

INCLUSIVE CRITERIA:

1)Patients of age 18-60 will be selected

2)Patients who will give consent for the study.

3)Both Sex

4)Patients with all types of Dushtavranawith maximum history of ≥2 weeks

5)Patients having clinical features of NijaandAgantuja Vranai.e.foul smell ,pus discharge,pain,burning sensation and edema will be selected for study.

6)Wound size upto 8cm×8cmwill be selected.

EXCLUSIVE CRITERIA:

1.The patient whohas underlying bony lesions 2. Patientswith Malignant Ulcer.

  1. Tuberculous Ulcer.

  2. Lepromatous Ulcer.

5.HIV, HbSAg positive patients.

  1. Bleeding disorders.

  2. Gangrenous wound.

8.Diabetic Wound will not be selected.

Method of selection ofTrialor Control Group:-

TRIAL DRUG: Vranaropak lepa(madhuyukta sharpunkha)will be prepared according toChakradatta & Jaloukavacharan.

CONTROL DRUG:Patients subjected to Proprietary Modern Medicine.

Study Population:

70patients fulfilling the criteria and attending the OPD/IPD of Shalyatantra department of the Hospital taken for study.

Specification of Instruments and related

measurements:

A)For Madhuyukta SharpunkhaVranaropak Lepa:Khalvayantra(Mortar and pestle)

Patra(vessel),spoon-Dressing material,normal saline

B) For Jalouka: -

-Haridra(turmeric)

-water pot with water

-Dressing material

-Normal saline

SAMPLE SIZE:

Group-A(Trial Group)-35

Group-B(Control Group)-35

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of age 18-60 will be selected 2)Patients who will give consent for the study.
  • Both Sex 4)Patients with all types of Dushtavranawith maximum history of ≥2 weeks 5)Patients having clinical features of NijaandAgantuja Vrana i.e.foul smell ,pus discharge,pain,burning sensation and edema will be selected for study.
  • Wound size upto 8cm×8cmwill be selected.

排除标准

  • 1.The patient who has underlying bony lesions
  • Patientswith Malignant Ulcer.
  • Tuberculous Ulcer.
  • Lepromatous Ulcer.
  • HIV, HbSAg positive patients.
  • Bleeding disorders.
  • Gangrenous wound.
  • 8.Diabetic Wound will not be selected.

结局指标

主要结局

1)To compare the effectiveness of Madhuyukta Sharpunkha Lepa

时间窗: 45 days

(Vranaropak Lepa )and Jaloukavcharan with Metrogyl-P ointment in infected wound.

时间窗: 45 days

2)To propose an alternative easily available herbal preparation in the management of Dushtavrana.

时间窗: 45 days

3)To assess the treatment duration of Dushta Vrana( Infected wound) using study drug topically.

时间窗: 45 days

4)To find out therapeutic measures(Jalaukavacharan) that would be useful in the management of ulcer healing which will be cost effective .

时间窗: 45 days

次要结局

未报告次要终点

研究者

发起方
Dr Monica santosh Patil
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Monica santosh Patil

Vidarbha ayurvedic mahavidyalaya Dastur nagar Amravati 444606

研究点 (1)

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