Clinical Profile

Wound healing is a natural and dynamic process. The use of natural products to
enhance wound healing is a common practice in many parts of the world. The
proposed of the trial drug being cost effective, easily available, promising therapeutic
effect along with no adverse reaction, would be useful for the management of burn
wound.

AIM OF THE STUDY:

“A CLINICAL STUDY ON DURDAGDHA W.S.R TO SECOND DEGREE

SUPERFICIAL BURN AND ITS MANAGEMENT WITH INDIGENOUS DRUGS.”

OBJECTIVES:-

• To review of literatures regarding disease and drugs.

• To see the efficacy of trial drug (an indigenous drugs).

• To see the efficacy of control drug (silver sulfadiazine).

HYPOTHESIS: (Su. Su. 12/26, 27)

1. Madhuchhista, madhuka, lodhra, sarjarasa, manjishtha, rakta chandan,

murva – 1 part each, Go-ghrita – 4 parts and Water – 16 parts.

Materials & methods:

Research records:

Studies relating to these topics have been collected from books, journals,
research article etc.

Patients:

45nos. of patients were selected from O.P.D, I.P.D of GOPABANDHU

AYURVEDA MAHAVIDYALAYA & HOSPITAL, PURI. D.H.H, Puri and different
health camps and divided randomly into two groups i.e. Group-T having 30 nos. of
patients and Group-C having 15 nos. of patients.

 Trial group: - An indigenous drugs.

 Control group: - Silver sulfadiazine.
 Total study duration: - 30 days.
 Dose: - Depending upon the size of the wound.
[A clinical study on durdagdha w.s.r to second degree superficial burn and its 61
management with indigenous drugs.]
 Clinical Profile

Method:

SAMPLING: Randomly allocated.

TYPE OF STUDY: Control single blind clinical trial.

INCLUSION CRITERIA:

Patients having second degree superficial burn injury i.e. <20% in adult and
<10% in child having no systemic diseases.

EXCLUSION CRITERIA:

• Second degree deep, third and fourth degree burn.

• Frost bite, electrical burn, radiation burn, and chemical burn, Inhalation injury.

• Immune compromised diseases like AIDS, TB, etc.

• Diabetes mellitus

• Severe anaemia.

INVESTIGATION:

 D.C, T.L.C, Hb%, F.B.S/R.B.S

ASSESSMENT CRITERIA:

The result has been evaluated by both subjective and objective parameters
based on clinical observations.

Subjective parameters –

 Pain
 Tenderness
 Discharge

Objective parameters-

 Blister/size of the burn wound.

 Presence of slough.
 Scar formation.
 Granulation tissue formation.

[A clinical study on durdagdha w.s.r to second degree superficial burn and its 62
management with indigenous drugs.]
 Clinical Profile

PLAN AND DESIGN OF STUDY:-

 Selected cases have immediately undergone clinical examination to assess the

present condition. 30 nos. of patients were kept in Group-T with external
application of indigenous drugs and 15 nos. of patients were kept in Group-C
with local application of silver sulfadiazine.

SIGLE GROUP DESIGN:-

Gr.T(B.T) vrs Gr. T(A.T) Effectiveness of T.D has been assessed.

Gr. C (B.T) vrs Gr. C (A.T) Effectiveness of C.D has been assessed.
DOUBLE GROUP DESIGN:-

Gr.T vrs Gr. C Effectiveness of T.D w.r.t C.D has been assessed.

 Gr. T-Trial group (indigenous drugs), Gr.C-Control group (Silver sulfadiazine)

 B.T- Before treatment, A.T- After treatment.

Assessment criteria:

The clinical values were assessed by subjective and objective methods. Hence,
it was viewed that the statement or expression of the symptoms of the patients.

Assessment grading:

1. Pain (Burning) - The assessment of pain was done using internationally accepted
Numerical Ranging Scale (NRS).

Numerical Rating Scale [NRS]: 0-10 rating

GRADE GRADE REMARK

POINT
G0 0 Normal/Absent
G1 1 Mild pain(1-3)
G2 2 Moderate( 4-6)
G3 3 Severe (7-10)

[A clinical study on durdagdha w.s.r to second degree superficial burn and its 63
management with indigenous drugs.]
 Clinical Profile

2. Tenderness:

Tenderness was measured by palpating the wound by physician.

GRADE GRADE REMARK

POINT
G0 0 No tenderness.
G1 1 Mild tenderness on deep pressure.
G2 2 Moderate tenderness on normal pressure.
G3 3 Severe tenderness on touch.

3. Discharge:

This was measured by counting numbers of gauze pad soaked.

GRADE GRADE REMARK

POINT
G0 0 No discharge.
G1 1 Mild- serous discharge (1 pad/day)
G2 2 Moderate-serous discharge (2pads/day)
G3 3 Severe-serous discharge (>3 pads/day)

4. Improvement scale of Blister/size of the wound gradation:

Blister is formed immediately after burn. It may or may not burst and wound
occurs. A sterilized blotting paper was used to determine the size of the wound. A
dried sterilized blotting paper was placed over a wound. Then blotting paper was
placed on graph paper and the size of the wound was assessed by cm2.

BLISTER/WOUND SIZE REMARK

25% heal Mild improvement.
50% heal Moderate improvement.
>75% heal Maximum improvement.
100% heal Total improvement.

[A clinical study on durdagdha w.s.r to second degree superficial burn and its 64
management with indigenous drugs.]
 Clinical Profile

5. Slough:
The presence of slough was assessed by naked eye of the physician.

GRADE GRADE REMARK

POINT
G0 0 No slough.
G1 1 Less than 1/3rd of wound.
G2 2 More than 1/3rd but less than 2/3rd of wound
G3 3 More than 2/3rd of wound.

6. Granulation tissue formation:

This was also assessed by naked eye examination.

SCORE REMARK
0 Healed completely.
1 Granulation tissue present.
2 Granulation tissue absent.
3 Slough present.

7. Scar formation:

The presence of scar tissue was assessed by naked eye examination.

GRADE GRADE REMARK

POINT
G0 0 No scar tissue.
G1 1 Less than 1/3rd of wound.
G2 2 More than 1/3rd but less than 2/3rd of wound
G3 3 More than 2/3rd of wound.

[A clinical study on durdagdha w.s.r to second degree superficial burn and its 65
management with indigenous drugs.]
 Clinical Profile

Assessment of Result:

Statistical analysis:

For the purpose of the assessment of result, we have used some grade points as
follows:

Severity grade Grade point

G3 3
G2 2
G1 1
G0 0

In order to prove the effectiveness of the trial drug scientifically all the
assessment has been statistically analysed and the derived mean value was shown. In
this statistical analysis, the mean (M) and standard deviation (S.D) of each sign and
symptoms before treatment has been compared with the mean and standard deviation
(S.D) of after treatment. The effectiveness of the trial and control drug to each sign
and symptoms has been assessed through p-value.

CLINICAL ASSESMENT OF RESULT:

The clinical assessment of result was made as follows:-

CURE - 100% (Total improvement of cardinal sign and symptoms)

MAXIMUM IMPROVEMENT - 75-99% (On an average)

MODERATE IMPROVEMENT - 50-74 %( On an average)

MILD IMPROVEMENT - 25-49 %( On an average)

UNSATISFACTORY - 0-24 %( On an average)

[A clinical study on durdagdha w.s.r to second degree superficial burn and its 66
management with indigenous drugs.]