AIMS
& OBJECTIVES
1.
To evaluate the efficacy of Virechana karma in the management of Shvitra.
2.
To evaluate the efficacy of by Jyotismati Tail Abhayag (Ekang/Sarvang ) in
the management of Shvittra.
3.
To compare the effect of Virechana karma
and Jyotismati Tail Abhayag (Ekang/Sarvang in the management of Shvitra.
MATERIAL AND METHODS
Procedure of Virechana Karma
Purva Karma –For Deepan, Pachana Karma, Trikatu churna will
be given in a dose of 3 to 6 gms BD as
per the koshtha of patients.
Pradhana karma -After administration of snehana and on empty
stomach after the time of Kapha has been pass Nishothadi Kwatha will be given to the
patient as per kostha of patient.
Paschata Karma – Patient should adviced for Sansarjana
Karma as per type of Shuddi obtaine.
Purva Karma – Ask to the patient to wash the affected aria
with lukewarm water prior to application of
Jyotismati Tail Abhayang.
Pradhana karma - Freshly prepared and Jyotismati Tail Abhayag (Ekang/Sarvang ) applie the over affected aria.
Paschata Karma – Patients suffer from mild to moderate
burning sensation afterapplication of abhayang. Blister got develop within 2 to
3 days after application of oil .Till they get disappear as new skin grows .
PLAN OF STUDY:
Clinical
Study: For the clinical study, patients attending
OPD and IPD of the Panchkarma Department of Rishikul Campus, Haridwar.
Total No. of Patients : 40
Type of study : open
study
Level of study
: O.P.D.
& I.P.D. level
Period of study : 60 days
FOLLOW UP: The
follow up will be of one month after completion of treatment to observe the effect
of treatment or any adverse effects etc.
B) INCLUSION
CRITERIA-
• Vitiligo
with classical signs and symptoms.
• Age
group 15 to 70 years.
C) EXCLUSION
CRITERIA-
• Pregnant
women and lactating women.
• Vitiligo
linked with other disease that is Hypertension, Diabetes, Tuberculosis,
Rheumatoid Arthritis, and Anemia.
• Patches
over genital areas.
• Known
cases of leprosy.
• Rapidly
spreading Vitiligo patches and associated with blisters and rubor during
treatment.
• Vitiligo
patches complicated by eczema and burns.
• Extensive
and complete dipigmented Vitiligo.
• Congenital
pigmentation disorders.
For present study minimum 40 patients will be
selected on the basis of inclusion & exclusion criteria
D) SAMPLE
SIZE- 40 patients will be taken for the study
Grouping: In
each group 20 patients will be taken for trial.
Group A –
Patients in this group will be administered with 2 Sittings of Virechana karma procedure.First
Deepan-Paachan then Snehapaan followed by administration
of Virecnana dravy.Then,Samsarjana karma will be followed as per
type of shudhhi.
GROUP
B: -20 patients of Shivitra will be treated with externally .
Classical virechana
karma includes Deepana ,Pachana,Snehpana, Abhyanga and Swedana administration
Sanshodana kalpa and Samsarjana karma.
Demographic data was collected from the
registered patients along with base line assessment as per the proforma. Periodic assessment of the signs and
symptoms was done at
interval of 15-15 days .A follow-up assessment
will be done after 2 month to check the recurrence or any associated complain
after withdrawing the therapy .
CRITERIA FOR WITHDRAWAL
§
Personal Matters.
§
Aggravation of complaints.
§
Inter-current illness.
§
Any other
difficulties.
§
Leave against medical advice (LAMA).
OBSERVATION &
ASSESSMENT:
Observation
will be carried out at interval of 15 days for 60 days.
Observation
of patient will be carried out before, during and after the treatment.
Patients
will be evaluated for severity of illness during and after the intervention
based on parameters and investigations.
·
Any addition or exclusion
may be included as necessity of the study.
Assessment
will be done statistically.
Research
Proforma::
A detailed research Proforma will be
prepared incorporating all the points from Ayurvedic as well as modern
aspect to study the patients as well as disease.
CRITERIA FOR
ASSESSMENT
} The
improvement in patients will be asses on the basis of relief in sign and
symptoms of the disease. All the signs symptoms were given
scoring depending upon their severity to assess the effect except VASI Which
was directly calculated by using the formula (VASI=
HAND UNITS]×[RESIDUAL DEPIGMENTION])
after each visit of the patient for better assessment of the trial methodology
used. Color -
} Normal
skin color – 0
} Red
color – 1
} Red
Pale – 2
} Pale
white – 3
} Margin
} Normal
skin color attributed. – 0
} Hyper-pigmented
thick broad with graduated margin. –
1
} Hyper-pigmented
broad with graduated margin.
– 2
} Hyper-pigmented
well defined margin.
– 3
} Hyper-pigmented
thin edge margin. – 4
} Well
defined margin.
–5
Signs
and symptoms
Color
-;
Normal
skin color – 0
Red
color – 1
Red
Pale – 2
Pale
white – 3
Margin;
Normal
skin color attributed. – 0
Hyper-pigmented
thick broad with graduated margin. – 1
Hyper-pigmented
broad with graduated margin. – 2
Hyper-pigmented
well defined margin. – 3
Hyper-pigmented
thin edge margin.
– 4
Well
defined margin. –5
INVESTIGATIONS:
o Hb%
Waist
o circumference(in
inches)
o T.L.C
o D.L.C
o Random
blood sugar.
o Waist
circumference(in inches)
o Total
cholesterol/HDL
o HDL/LDL.
o Erythrocyte
sedimentation rate (ESR).
These
investigations will be carried out before and after completion of therapy.
STATISTICAL ANALYSIS:.
To obtain the efficacy of
the therapy on Objective parameters, proper
statistical analysis will be cerried out of available data.
1.
Within the group
parametric by – t- paired.
2.
Within the group non-parametric by Wilcoxon test.
3.
Inter group
parametric by Chi- squared.
4.
Inter group
non-parametric by Mann- Whitney U test.
CONCLUSION:
The
result will be analyzed statistically and discussed. Conclusion will be made on
the basis of the observation which is done on subjective parameters. |