A Randomized Controlled Trial To Evaluate The Efficacy of Kshara Karma And Rasakriya In The Management Of Dushtavrana

SCOPE AND STATEMENT

Many chronic wounds do not heal simply because of inadequate wound care, especially in the rural setting. Chronic wounds are relatively common condition amongst adults, the cost to health care of managing Chronic wounds is not only financial, it can also affect the quality of life of patient in terms of mobilisation, nutrition, sleep, social-isolation, malodour, pain and infection. People may have to cope with specialised devices or beds, dressing changes, drainage, odour, clothing limitations and sleep deprivation. Chronic wounds can lead to complications such as infection, pain and limb amputation. Patients affected by these types of wounds often require assistance in performing common daily tasks. Neglect can lead to malnutrition, further morbidity and mortality. The value of cleansing Chronic wounds is considered a basic principle in the Wound management. Hence, looking at the clinical efficacy and a non-invasive procedure, the Kshara karma and Rasakriya are adopted to treat the problem wounds.

OBJECTIVES OF THE STUDY

• To evaluate the efficacy of Kshara karma in the management of Dushtavrana.

• To evaluate the efficacy of Rasakriya in the management of Dushtavrana.

• To compare the efficacy of Kshara karma and Rasakriya with that of Standard wound cleansing in the management of Dushtavrana.

HYPOTHESIS

H0 – There is no significant effect of Kshara karma in the management of Dushtavrana.

There is no significant effect of Rasakriya in the management of Dushtavrana.

H1 – There is significant effect of Kshara karma over Standard Wound Cleansingmethod in the management of Dushtavrana.

H2 – There is significant effect of Rasakriya over Standard Wound Cleansing method in the management of Dushtavrana

H3 – There is significant effect of Kshara karma over Rasakriya in the management ofDushtavrana.

H4 – There is significant effect of Rasakriya over Kshara karma in the management ofDushtavrana.

H5 -- There is significant effect of Kshara karma and Rasakriya over Standard Wound Cleansing method in the management of Dushtavrana.

RESEARCH QUESTION

Whether the Kshara karma and Rasakriya is effective over Standard cleansing method when applied for a period of 10 days in the management of Dushtavrana?

METHODOLOGY, TOOLS AND TECHNIQUES

1.ANALYTICAL STUDY

a)      Drug collection: Trial drugs will be procured from GMP Certified Ayurvedic Pharmacy

b)      Drug Identification and Authentication will be done in Ayush approved drug testing

c)      laboratory

d)     Physico-chemical Analysis of Palasha Pratisaraneeya Teekshna Kshara

e)      Physico-chemical Analysis of Rasakriya

f)       Microbial Study of Rasakriya

EXPERIMENTAL STUDY

Rasakriya will be subjected for Acute-Dermal Toxicity as per OECD guidelines 43430.

CLINICAL STUDY

1.      STUDY TYPE - Interventional

2.      STUDY DESIGN - Prospective

3.      MASKING - 3-Armed, Randomized, Controlled

4.      END POINT - Efficacy

5.      SAMPLE SIZE & CALCULATION

Sample size – 45 in each group

6.      Randomization – Computer generated random number

7.      Total Number of Subjects

135 (Group A – 45, Group B – 45, Group C – 45)

SOP

SOP will be prepared for Kshara Karma and Rasakriya

INTERVENTION

GROUP A

Poorva Karma: Wound and its surrounding area will be cleaned with Normal saline.

Pradhana Karma: Wound cleansing by Hydrogen peroxide and Debridement (as necessary), followed by application of Povidone Iodine solution 5%.

Pashchat Karma: Sterile pad will be kept over the wound and bandaging will be done.

GROUP B

Poorva Karma: Wound and its surrounding area will be cleaned with Normal saline.

Pradhana Karma: Palasha Pratisaraneeya Kshara will be applied directly to the wound bed covered with slough or necrotic tissue till 100 matra kala. Later, Kshara will be removed and Nimbu swarasa will be applied to nullify the action of Kshara, followed by application of Yastimadhu and Ghrita.

Pashchat Karma: Sterile pad will be kept over the wound and bandaging will be done.

GROUP C

Poorva Karma: Wound and its surrounding area will be cleaned with Normal saline.

Pradhana Karma: Rasakriya mixed with Matulunga rasa and Madhu will be applied over the wound**.**

Pashchat Karma: Sterile pad will be kept over the wound and bandaging will be done.

DIAGNOSTIC CRITERIA

Based on signs and symptoms of Dushtavrana30 –

1. Krishna, Rakta, Peeta, Shukla-Varna

2. Durgandhitha Puya SravaYukta

3. Vedanavaan

4. Daha-Paka-Raga-Kandu-Shopha-Pidikayukta

5. Dushta-Shonita Sraavi

6. Deerghakaalaanubandhi

 INCLUSION CRITERIA

1. Patient age: 18 years to 60 years of either gender

2. Patients having clinical features of Dushta Vrana i.e. foul smell, pus discharge, pain, oedema etc will be selected for study

3. Wound size: Within 6x6 cm

4. Wound depth: – Extends through both the epidermis and dermis, with no exposed tendon or bone

5. Wound duration: – More than 7 days

6. Wound bed characteristics: – Wound bed with slough/necrotic tissue and exudate

7. Venous ulcer, Ischemic ulcer, Trophic ulcer, Neurogenic ulcer, Tropical ulcer, Traumatic wounds

 EXCLUSION CRITERIA

1. Exposed bone, tendon or facia, Ulcer associated with Osteomyelitis

2. Systemic diseases like Diabetes, Tuberculosis, Syphilis, Leprosy, Malignancy, HIV, HbsAg

3. Burn wounds, Anaemia (Hb% <10 gm/dl), Uraemia, Jaundice

4. Patient suffering from signs of Cellulitis and Gangrene

5. Receiving corticosteroids or immune suppressive drugs

ASSESSMENT CRITERIA

1. Subjective Parameters

Pain (assessed by VAS Scale)

2. Objective Parameters – Bates Jensen Wound Assessment tool.

SCHEDULE OF PROPOSED RESEARCH WORK GROUP

Group A (Control Group) - Standard wound cleansing will be done daily until Shuddha vrana laxanas are seen or maximum for 10 days, Whichever earlier

Group B - Kshara karma will be done on every 3rd day, followed by daily dressing with application of Yashtimadhu and ghrita until Shuddha vrana laxanas are seen or maximum for 4 sittings, Whichever earlier

Group C - Rasakriya will be applied on every 3rd day until Shuddha vrana laxanas are seen or maximum for 4 sittings, Whichever earlier

WITHDRAWAL CRITERIA

The principal investigator may stop the subject participation in the study at any time for one or more of the following reasons

a) Any serious adverse effects requiring major interventions

b) Any time during the study continuation of study drug could lead to harmful effect.

c) Any untoward event where in investigator feels continuation of trail may jeopardize the health state of the subject.

d) Subjects failure to follow the instructions of the principal investigator.

e) If patients needs treatment that are not allowed in the study.

f) If the investigator opines that continuation in the study could be detrimental for patient’s health.

g) Other administrative reasons.

 FURTHER MANAGEMENT OF WOUND AFTER TREATMENT / TRIAL PERIOD

• On the basis of wound assessment, further treatment will be planned accordingly and the patient will be monitored till complete Wound healing.

• If the wound is large, the patient will be referred to the higher centre for Skin grafting.