A Clinical Study On Split Thickness Skin Graft(STSG) With And Without Jalaukavacharana And Mamsarohini Twaka Kwatha Prakshalana As Pre-Treatment In The Management Of Dushta Vrana (Chronic Non Healing Ulcer)

RESEARCH QUESTION

Whether the Jalaukavcharanaa and Mamsarohini twaka Kwatha prakshalana as Pre-treatm ent of Split Thickness Skin Graft(STSG) In The Management Of Dushta Vrana (chronic non healing ulcer) is useful to reduce rejection of graft or not?

HYPOTHESIS

Null Hypothesis (H0) –There is no significant difference in acceptance of graft with and without Jalaukavacharanaa and Mamsarohini twaka kwath prakshalana as pre-treatment of Split Thickness Skin Graft (STSG) in the surgical management of Dushtavrana (Chronic non healing ulcer).

Alternative Hypothesis (H1)– There is significant difference in acceptance of graft with and without Jalaukavacharanaa and Mamsarohini twaka kwath prakshalana as pre-treatment of Split Thickness Skin Graft (STSG) in the surgical management of Dushtavrana (Chronic non healing ulcer).

AIM

To Evaluate and compare the effect , with and without Jalaukavacharana and Mamasarohini twaka Kwatha prakshalana as Pre-treatment in the Acceptance or Rejection of Split Thickness Skin Graft (STSG).

OBJECTIVES

• To Evaluate the Effect of Jalaukavacharana and Mamasarohini twaka Kwatha prakshalana as Pre-treatment of Split Thickness Skin Graft (STSG) in the surgical management of Dushta vrana (Chronic non healing ulcer).

• To Evaluate the Acceptance or Rejection of graft with Jalaukavcharna and Mamsarohini twaka Kwatha Prakshlana as Pre-treatment of Split Thickness Skin Graft (STSG) in the surgical management Dushta vrana (Chronic non healing ulcer).

• To Evaluate the Acceptance or Rejection of graft without Jalaukavacharanaa and 8 Mamasarohini twaka Kwatha Prakshalana as Pre-treatment of Split Thickness Skin Graft (STSG) in the surgical management Dushta vrana (Chronic non healing ulcer).

PLAN OF THE STUDY

REVIEW OF LITERATURE: In this phase of study, various Ayurvedic and modern literatures related to the present research work will be studied thoroughly. Also, the articles related to the present topic published in renowned and reputed journals will be reviewed thoroughly. Under this phase of study, following topics will be reviewed; • DRUG REVIEW A detailed study of Mamsarohini from Ayurvedic texts, research papers etc. will be done and compiled.

PROCEDURE REVIEW

In procedure review, detailed description of Split Thickness Skin Graft (STSG) and Jalaukavacharana will be described on basis of classical texts of Ayurveda and Modern aspect.

• DISEASE REVIEW

In disease review, detailed description of Dushta vrana(Chronic non healing ulcer) will be described on the basis of classical texts of Ayurveda and modern aspect.

EXPERIMENTAL STUDY:

• Pharmacognostical study: This study will be done for authenticity at the Department of Dravyaguna of Government Akhandanand Ayurved college, Ahmedabad.

CLINICAL STUDY: It is a clinical study. In this study total 14 patients randomly selected as per inclusion criteria and randomly divided in 2 groups and each group has same number of patients. A special proforma will be prepared incorporating all points of history taking, physical signs and symptoms, clinical examination and investigation.

STUDY DESIGN:

● Study Type : An Open label Randomized Controlled Clinical Trial

● No. of Groups : 2 (7 patients in each group)

● Sample size: : 7 patients in each group

● Location of study : Study will be conducted at Government Akhandanand Ayurved Hospital, Ahmedabad and Maniben Ayurved Hospital,Ahmedabad.

ETHICAL CLEARENCE & CTRI REGESTRATION:

Approval from Institutional Ethics Committee (IEC) for clinical trials will be obtained prior to the initiation of the study. CTRI registration will be done in due course of time.

• All the patients will be given complete idea about the clinical trial. Patients will be randomly divided into 2 groups by computerized randomization method.

• The baseline screening will be done by fulfillment of case record form, which will be designed with detailed clinical history, general and physical examination, assessment of involved Dosha, Dushya, Ama, Agni, Srotasa etc., assessment of treatment.

• Prior written informed consent will be taken from the enrolled patients. All the patients will be assessed clinically before and after the treatment. Assessment will be done on the basis of improvement in signs and symptoms of the disease by specific screening patterns. All the subjective symptomatology will be given specific scores.

POSOLOGY OF DRUG:

Drug

Latin Name

Part used

|Mamsarohini

Soymida febrifuga A. Juss.

Bark

GROUPING:

The selected patients will be divided into two equal groups – Group A & Group B

**Group A (Trial
Group)**

Split Thickness Skin Graft (STSG) with Jalaukavacharana and Mamasarohini twaka Kwatha Prakshalana as pre-treatment in Dushta vrana (Chronic non healing ulcer).

|Group B (Control Group)

Split Thickness Skin Graft (STSG) without Jalaukavacharanaa and Mamasarohini twaka Kwatha Prakshalana as pre- treatment in Dushta vrana (Chronic non healing ulcer).

CRITERIA FOR ASSESSMENT

Acceptance of STSG will be determined according to following criteria given below:

OBJECTIVE CRITERIA:

No.

Criteria name

Gradation

|1.

Adherence of graft

Grade-0:   Fully Adhere

Grade-1:   Half Adhere

|  Grade-2:   Partially Adhere (< Half)

Grade-3:  No Adhere

|2.

STRAVA (Discharge)

Grade-0:  No Discharge

Grade-1:  Serous Discharge

Grade-2:  Serosanguinous

Grade-3:  Pus Discharge

|3.

VARNA (Colour)*

Grade-0: same as normal skin colour

Grade-1:  +1 then normal skin colour Grade-2: +2 then normal skin colour

Grade-3: +3 then normal skin colour

Grade-4: +4 then normal skin colour

Grade-5: >+4 then normal skin colour

SUBJECTIVE CRITERIA:

Pain

INVESTIGATIONS :

•       CBC

•       HCV

•       ESR

•       HbA1c

•       HIV

•       RBS

•       HBsAg

•       BT & CT

•       S.Creatinine (if needed)

•       Billirubin(total,direct,indirect) (if needed)

•       Urine analysis (Physical, Chemical, Microscopic)

•       LFT (if needed)

•       RFT (if needed)

•       Arterial &Venous Doppler (if needed)

STATUS OF ONGOING MEDICINES AND TREATMENT :

If patient is taking any other medicine for any systemic disease, then it will be continued.

WITHDRAWAL CRITERIA:

•       During the trial period, In case of any complications occurs ,

•       Personal reasons of patients.

REPORTING ADR:

Adverse Drug Reaction (ADR), if observed will be registered and reported to Peripheral Pharmacovigilance Centre (PPvC), GAAC, Ahmedabad.

STATISTICAL ANALYSIS:

Mean score, Standard Deviation (S.D.), Standard Error (S.E.), % of relief, common ‘t’ test, Wilcoxon rank sum test , Mann Whitney U test and other suitable statistical tools will be applied to assess the significance of the results.

STANDARD PROFORMA:

Standard Proforma will be developed and used in the study to evaluate the comparative efficacy of the trial drug.

PRESENTATION OF DATA:

The data collected, analyzed will be depicted as general observations viz. age, gender, religion etc. The results of individual investigations will be presented by a proper bar diagram, pie diagrams etc.

DISCUSSION AND CONCLUSION:

After getting all the data, discussion and conclusion will be done as per the observations and results.

DECLARATION:

The study will be completed in the stipulated time limit. The work will be carried out after getting clearance from the institutional ethics committee. The data related to the identification of the patient will be kept confidential. The clinical data obtained will be summarized at the end of the study.