Randomised controlled clinical trial to evaluate the efficacy of raktamokshana using siravedha in vranashotha w.s.r. to acute inflammatory diseases

TITLE :- RANDOMISED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF RAKTAMOKSHANA USING SIRAVEDHA IN VRANASHOTHA W.S.R. TO ACUTE INFLAMMATORY DISEASES

INTRODUCTION :- Shalyatantra is a branch of Ayurveda which was specialised & developed by Acharya Sushruta known as father of surgery who has elaborated various surgical & parasurgical procedures in the precious grantha Sushrut Samhita. Rakta is considered as fourth dosha in addition to Tridoshas by Acharya Sushruta1 & Raktamokshana is described as one of the parasurgical procedure which has given prime importance & considered as half part of the treatment in surgical diseases as that of Bastichikitsa in medical diseses2 . Raktamokshana is further classified in two types Shastrakruta & Ashastrakruta3 . Siravedha & Pracchan comes under Shastrakruta Raktamokshana while Jalaukavacharan, Shringa & Alabu are included in Ashastrakrut Raktamokshana4 . Siravedha type of Raktamokshana is indicated specifically to evacuate deep seated impurities in the body which occurs due to vitated tridoshaj5 . Vranashotha is a condition which occurs in many diseses due to vitated tridoshaj due to internal metabolic disturbances or external factors like hazardous microbes, insect toxins, chemicals, heat, physical trauma etc. Vranashotha is a localised swelling affecting Twacha & Maans which can occur in any body part due to accumulation of vitated doshaj6 . Acute inflammation is a short duration process occurring in response to tissue injury, usually appearing within minutes or hours7 .It is characterized by five cardinal signs: pain, redness, swelling, Rise in temperature & loss of functions of the affected tissues8 . C- Reactive protein, ESR & Plasma viscosity are the blood tests considered as inflammatory markers for the evaluation & prognosis of acute inflammatory diseases9 . Among the three stages of Vranashotha first stage is Amavastha10 which can be considered as acute inflammatory stage is indicated for Avasechan11 among the seven procedures in the treatment of Vranashotha. Avasechan can be considered as Page 2 of 29 Raktavsechan which is indicated for pain relief & to avoid further suppurative changes in Amavastha of Shotha i.e. acute inflammation12 . Previously researches are conducted on the efficacy of Jalaukavacharana & lepan chikitsa on Vranashotha. Previously no researches are found on the efficacy of Siravedha in Vranashotha. These procedures are more time consuming than siravedha. Also some patients are anxious about Jalauka & excessive bleeding may occur after Jalaukavacharan. Some adverse effects on skin may occur due to lepas. Due to Vranashotha i.e. inflammatory pathology Sthanik (loclised inflammation) as well as Sarvadaihik Raktadushti (increased WBC count & CRP levels) occurs. Siravedha is indicated for Sarvadaihik Raktadushti. In day to day practice number of patients having acute inflammatory pathology is noticeable & requires immediate attention to avoid further complications. Hence considering the correlation of Vranashotha with Acute inflammation & indication of Raktamokshana in Vranashotha i.e. Acute Inflammatory Conditions the topic RANDOMISED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF RAKTAMOKSHANA USING SIRAVEDHA IN VRANASHOTHA W.S.R. TO ACUTE INFLAMMATORY DISEASES is selected for the study.

RESEARCH QUESTION :- Is Raktamokshana using Siravedha effective in reducing the clinical features of Vranashotha w.s.r. to Acute inflammatory diseases?

HYPOTHESIS :-

H0 - Raktamokshana using Siravedha is not effective in reducing the clinical features of Vranashotha w.s.r. to Acute inflammatory diseases.

H1 - Raktamokshana using Siravedha is effective in reducing the clinical features of Vranashotha w.s.r. to Acute inflammatory diseases

AIM :- To Evaluate the add on efficacy of Raktamokshana using Siravedha in reducing the clinical features of Vranashotha w.s.r. to Acute Inflammatory Diseases.

OBJECTIVES :-

1. To study the add on efficacy of Raktamokshana using Siravedha in reducing the clinical features of Vranashotha w.s.r. to Acute inflammatory diseases.

2. To study about clinical & pathological changes after Raktamokshana using Siravedha in Vranashotha w.s.r. to Acute inflammatory diseases.

3. Literary review of Raktamokshana & Vranashotha

STUDY DESIGN :- Randomized Controlled Clinical Trial.

SAMPLING TECHNIQUE :- Simple Randomized Sampling.(Lottery Method)

SAMPLE AREA :- Patients coming in OPD and IPD of Shalyatantra department of our hospital with classical signs and symptoms of Vranshotha i.e. Acute Inflammatory Diseases.

SAMPLE SIZE :-100 Patients will be randomly selected and equally distributed in two groups. i.e 50 Patients in each group - A) Trial Group & B)Control Group

STUDY LOCATION :- Opd and Ipd of Shalyatantra department of Research Center & Currently Employed Ayurveda College

FOLLOW UP :- At 0th day, 4th day, 7th day & 10th day

CONSENT: A well-informed written consent will be taken from all the patients included in the study before starting the treatment

Treatment Plan :-

A) Trial Group - Raktamokshana using Siravedha 60 ml twice on 1st day & 4th day Tab. Amoxicillin 500 mg + Clavulanic Acid 125 mg 1 Bid for 5 days; Tab. Diclomol SP 1 Bid for 5 days

B) Control Group - Tab. Amoxicillin 500 mg + Clavulanic Acid 125 mg 1 Bid for 5 days; Tab. Diclomol SP 1 Bid for 5 days

ASSESSMENT CRITERIA:-

A) Objective Parameters :-

1. CRP value - Before & After treatment

2. WBC Count - Before & After treatment

3. Neutrophill Count - Before & After treatment

B) Subjective Parameters :-

1. Dolar (pain & tenderness) - VAS scale; 2. Rubor (Redness/ Erythema) ; 3. Tumor (swelling); 4. Calor (Rise in local temperature ) ; 5. Loss of functions ; 6. Induration

DATA COLLETION TOOLS :

Case record form in OPD and IPD Ayurvedic Samhita, Ayurvedic textbooks Modern textbooks Investigations Review of literature Concerned material review from Articles & Books Information from Internet sources.

METHODS FOR DATA COLLECTION RELEVANT TO OBJECTIVES:

A) Total patients who are having Vranshotha (Acute Inflammation) will be selected from study area irrespective of age, sex, religion, education, occupation, diet. B) Case record form.

DATA MANAGEMENT AND ANALYSIS PROCEDURE: All information collected from a clinical study will be recorded in M.S. Excel Sheet and presented in the form of Graphs, Charts and Tables.

DATA ANALYSIS PLAN AND METHODS :

1. All information collected from a clinical study will be presented in the form of Graphs, Charts and Tables.
2. All the observed data will be analyzed and suitable statistical tests will be applied.