Pharmaceutico-Analytical Standarization of Swalp Khadir Vatika and its clinical evaluation in Mukhgatavrana with special reference to oral ulcers

THE PRESENT THESIS ENTITLED PHARMACEUTICO-ANALYTICAL STANDARIZATION OF SWALP KHADIR VATIKA AND ITS CLINICAL EVALUATION IN MUKHGATVRANA  WITH  SPECIAL REFERNECES TO ORAL ULCERS .

INTRODUCTION -

SWALP KHADIR VATIKA is a polyherbal formulation described in Bhaishajya Ratnavali for mukhrog,danta,oshta,jhihwaa and taalugatrog.Same formulation is mentioned is mentioned in Vrindhmadhavkar and Vangasena . Due to its versatile therapeutics ,standarisation of Swalp Khadirvti is the need of the hour for maintaining its quality .The present dissertation work is the pioneer attempt of Pharmaceutical Analytical Standarization of Swalp Khadir vatika and its clinical evaluation its effect on Mukhgata vrana with special reference to Aphthous Ulcers .  CONTENTS OF SWALP KHADIR VAITAKA ARE

1. KHADIR TWAK {ACAETIA CATECHU }

2. JAVITRI {MYRISTICA FRAGNANS}

3. KARPOOR{ CINNAMOMUM CAMPHORA }

4. POOGPHALA { ARECA CATECHU }

5. KANKOL { PIPER CUBEBA }

AIMS AND OBJECTIVE

1. To validate ingredients of ‘SWALP KHADIR VATIKA ‘’ {Procurement of genuine raw material and its verification as per standard specification in mentioned under Pharmaceutical study.}

2.To establish the SMP of “SWALP KHADIR VATIKA ”

3.To standardize the final product “SWALP KHADIR VATIKA

.4.To establish analytical parameters of “SWALP KHADIR VATIKA

5.To evaluate the clinical efficacy of the Swalp khadir Vatika in Mukhgat vrana with special reference to Aphthous ulcers

PLAN OF STUDY

1 .  CONCEPTUAL STUDY

A . LITERARY REVIEW

B . DRUG REVIEW

2. PHARMACEUTICAL  STUDY

3. ANALYTICAL  STUDY

A . ORAGANOLEPTIC STUDY

B . PHYSICO-CHEMICAL STUDY

3. CLINICAL STUDY

   

SAMPLE SOURCE - IPD AND OPD OF STATE AYURVEDIC COLLEGE AND HOSPITAL , LUCKNOW

AGE GROUP - 16-60 YEAR , SEX- MALE /FEMALE

DOSE - 1 TABLETS FOUR TIMES DAILY ,EMPTY STOMACH , DO NOT SWALLOW ,INSTEAD SUCK IN MOUTH   { EACH TABLET WILL BE 250MG }

DURATION OF STUDY WILL BE FOR 14 DAYS

FOLLOW UP- FOLLOW UP OBSERVATIONS WILL BE CONTINUED FOR 14 DAYS AFTYER COMPLETION OF CLINICAL TRIAL

SAMPLE SIZE - 50 PATIENTS IN THE GROUP

INCLUSION CRITERIA - AGE FROM 16-60 YEARS OF BOTH SEXES

FOCAL SIZE LESS THAN 1 CM ,

PATIENTS WITH MINIMUM 3 CLASSICAL SIGN AND SYMPTOMS OF  MUKHGATA VRANA /ORAL ULCERS

EXCLUSION CRITERIA -   PATIENTS BELOW 16 AND ABOVE 60 YEARS

IMMUNE COMPROMISED STATE , UNCONTROLLED DIABETES

INVESTIGATIONS - CBC , LFT  , VIRAL MARKER { IF REQUIRED }, RBS ,HBA1C , {IF REQUIRED }

CRITERIA FOR ASSESSMENT -

THE OVERALL ASSESSMENT  AS STATED BELOW-

1 . A PATIENT IN WHOM THERE WAS REDUCTION IN THE ASSESSMENT CRITERIA TO GRADE 0 AGAINTS THE INITIAL SEVERITY  SCORING IS CONSIDERED AS 91-100% . IT IS CONSIDERED AS GOOD  RESPONSE .

PATIENT IN WHOM THERE WAS REDUCTION IN 2 LEVELES OF THE ASSEMENT CRITERIA AGAINTS THE INITIAL SEVERITY SCORING IS TAKEN AS 61-90 % RESPONSE . IT IS TAKEN AS MARKED RESPONSE .

3.PATIENTS IN WHOM THERE WAS REDUCTION IN ONE LEVEL OF THE ASSESSMENT CRITERIA AGAINST THE INITIAL SEVERITY IS TAKEN AS 31- 60 %  RESPONSE .

4. PATIENTS IN WHOM ASSESSMENT CRITERIA REMAINED AGAINST THE INITIAL SEVERITY SCORING IS TAKEN AS 10-30% RESPONSE AND CONSIDERED AS POOR RESPONSE .