| 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: â— Study Type : An Open label Randomized Controlled Clinical Trial â— No. of Groups : 2 (7 patients in each group) â— Sample size: : 7 patients in each group â— 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
|
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. |