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临床试验/CTRI/2025/03/082943
CTRI/2025/03/082943尚未招募2/3 期

A comparative clinical study on the effect of madhuyashti ghrita and panchavalkala ghrita local application in the management of sadyo vrana

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan1 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24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
40
试验地点
1
主要终点
Complete healing of sadyovrana within 7 days of onset

研究概览

简要总结

AIM AND OBJECTIVES

1.     To evaluate the efficacy of Madhuyashti ghrita  local applicationin the management of Sadyovrana.

2.     To evaluate the efficacy of Panchavalkala Ghrita local application in the management of Sadyovrana.

3.     To compare the effectiveness of Madhuyashti ghrita with Panchavalkala Ghrita local application in the management of Sadyovrana.

INTRODUCTION

Skin injuries across the body continue to disrupt everyday life for millions of patients and result in prolonged hospital stays, infection, and death. Advances in wound healing devices have improved clinical practice but have mainly focused on treating macroscale healing versus underlying microscale pathophysiology. Consensus is lacking on optimal treatment strategies using a spectrum of wound healing products, which has motivated the design of new therapies. We summarize advances in the development of novel drug, biologic products, and biomaterial therapies for wound healing for marketed therapies and those in clinical trials. We also share perspectives for successful and accelerated translation of novel integrated therapies for wound healing

Vrana [1,2] is the commonest painful condition that every human being suffers in their life. Ayurveda texts have given prime importance to vrana and described the vrana in thoughtful manner. Wound healing procedures described by Sushruta still hold significant place today as well. Faster the wound healing, faster is the recovery of the patient, enabling him to resume his daily routine.

Madhuyashti ghrita3 and Panchavalkala ghrita4 are very much appreciated as wound healer. Madhuyashti ghrita is known to have good healing properties while Panchavalkala ghrita has a good grahi, shodhana and ropana effect. This study is planned to see the healing property of both drugs and also to give cosmetically neat and minimal scar. These two medicines are easily available, cost effective and can be tried on OPD basis.

SOURCE OF DATA Patients diagnosed as  Sadyo Vrana will be selected from Out Patient and In Patient Departments of P.G Studies in Shalya Tantra, Sri Dharmasthala Manjunatheshwara college of Ayurveda & hospital, Hassan.

SAMPLING TECHNIQUE: Randomize sampling

SAMPLE SIZE: 40

METHODOLOGY

Group A- Taken as Standard group

1.     Poorva Karma – Cleaning of the wound and surrounding with normal saline and sterile gauze.

2.     **Pradhana Karma –**Madhuyashti Ghrita application twice in a day for 7 days.

3. Paschata Karma – bandaging will by done by using sterile pad and roller and Advise the subject to maintain the hygiene.

4. Assessment will be done before treatment and on 7th day of treatment

5. Follow up: On 14th day and 21st day.

 Group B Taken as Trial group

**1.**Poorva karma- Cleaning of the wound and surrounding with normal saline and sterile gauze.

2. **Pradhana karma –**Panchavalkala ghrita application twice in a day for 7 days.

3. Paschata Karma – bandaging will by done by using sterile pad and roller and Advise the subject to maintain the hygiene.

4. Assessment will be done before treatment and on 7th day of treatment.

5. Follow up: On 14th day and 21st days

 MATERIAL AND METHOD OF PREPARATION

Preparation of Madhuyashti Ghrita will be procured by Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital, Hassan pharmacy

METHOD OF PREPARATION OF PANCHAVALKALA GHRITA:

Panchavalkala kwatha 16 parts, Panchavalkala Kalka 1 part, Goghrita 4 parts. Pachavalkala kwatha is prepared primarily, followed by adding Drava Dravya to Pachavalkala churna Kalka is prepared. Later it is mixed with the Sneha and Paka is done over Agni till the fumes stops & water content is evaporated and Samyak Gritha Paaka Lakshanas are obtained thus Panchavalkala Ghrita is obtained.

DIAGNOSTIC CRITERIA**:**

Based on signs & symptoms of Sadyovrana.

1.           Vrana kala (time period of vrana) less than 7 days.

2.           Shoola (Pain at wound site)

3.           Daha (Burning sensation over wound site)

4.           Vrana parimana (wound size)<36 sq cm as per bates & Jansen assessment criteria

  INCLUSION CRITERIA:

1.• Patients will be select from irrespective of gender, age, religion and occupation. etc

**2.**Patients having any one of classical features of Ghrushta vrana, Chinna vrana, Kshata vrana

**3.**wound size <36 sq cm as per bates & Jansen assessment criteria

EXCLUSION CRITERIA:

**1.**Bhinna vrana ,Viddha vrana,Picchit vrana

**2.**Patients suffering from leprosy, syphilis, Tubercular malignant wound, osteomyelitis, varicose veins

**3.**Dushta Vrana.

**4.**Traumatic wounds with severe complications like fracture, dislocation, severe hemorrhage.

**5.**Patients with other systemic illness like uncontrolled diabetes mellitus (HbA1c> 8%), Human Immunodeficiency Virus and Hepatitis B positive.

 ASSESSMENT CRITERIA:

ASSESSMENT CRITERIA: (BATES & JANSEN ASSESMENT CRETERIA)

Sl no

Item

Assessment

Day 1

Day 2

Day 3

Day 4

Day 5

Day 6

Day 7

| 1.

Pain

(Vedana)

0 - No pain

1- mild pain (1-3 in NPRS)

2 - moderate (4-6 in NPRS)

3 - severe (7-10 in NPRS)

        |2

Vrana Akruthi

(Size)

1- Length x width <4 sq cm

2- Length x width 4--<16 sq cm

3- Length x width 16.1--<36 sq cm

4-Length x width 36.1--<80 sq cm

5- Length x width >80 sq cm

|3**.**

Vrana oshta (Edges)

1- Indistinct, diffuse, none clearly visible

2- Distinct, outline clearly visible, attached, even with wound base

3- Well-defined, not attached to wound base

4- Well-defined, not attached to base, rolled under, thickened

5- Well-defined, fibrotic, scarred or hyperkeratotic

|4**.**

Mamsaankura (Granulation Tissue)

1- Skin intact or partial thickness wound

2- Bright, beefy red; 75% to 100% of wound filled &/or tissue

overgrowth

3- Bright, beefy red; < 75% & > 25% of wound filled

4- Pink, &/or dull, dusky red &/or fills < 25% of wound

5- No granulation tissue present

|5.

Twacha

(skin color surrounding the wound)

1- Pink or normal for ethnic group

2 -Bright red &/or blanches to touch

3 -White or grey pallor or hypopigmented

4 -Dark red or purple &/or non-blanchable

5 -Black or hyperpigmented

        |6.

Epithelization

1 = 100% wound covered, surface intact

2 = 75% to <100% wound covered &/or epithelial tissue extends > 0.5cm into wound bed.

3 = 50% to<75% wound covered &/or epithelial tissue extends to <0.5cm  into wound bed

4 = 25% to< 50% wound covered

5 = < 25% wound covered

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

入选标准

  • Patients having any one of classical features of Ghrushta vrana, Chinna vrana, Kshata vrana wound size less than 36 sq cm as per bates & Jansen assessment criteria.

排除标准

  • Bhinna vrana ,Viddha vrana,Picchit vrana
  • Patients suffering from leprosy, syphilis, Tubercular malignant wound, osteomyelitis, varicose veins
  • Dushta Vrana.
  • Traumatic wounds with severe complications like fracture, dislocation, severe hemorrhage.
  • Patients with other systemic illness like uncontrolled diabetes mellitus (HbA1c more than 8percentile), Human Immunodeficiency Virus and Hepatitis B positive.

结局指标

主要结局

Complete healing of sadyovrana within 7 days of onset

时间窗: Healing of sadyovrana within 7 days

次要结局

  • complete healing of sadyovrana will be quick when managed with panchavalkala ghrita application compared to that of madhuyashti ghrita application(Healing of sadyovrana within 7 days of onset)

研究者

发起方
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Santhosh Kumbar

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan

研究点 (1)

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