Pityriasis versicolor is well defined skin disorder with multiple asymptomatic mild itchy macular/ papular lesions with fine branny powdery scales having hypo or hyper pigmented macules (versi several). Initially the lesion occurs around the hair follicles but soon merges with each other to form large area which persists indefinitely and shows spontaneous remission and exacerbation. Ayurveda has a great potential in managing this condition along with overcoming the side effects of antifungals like stinging and swelling, irritation or redness of the treated skin and the time duration for the drug application is limited because it causes the toxicity which does not fulfill the need of treatment. Many a times, it so happens that even after treatment the hypo-pigmentation persists months after treatment and causes mental instability or social stigma to the patient. The toxic effects of topical mode of action of antifungals like allergic rashes, scars, itching, oozing, etc, so due to its short comings and after reviewing the Ayurvedic classics, drugs effective in conditions similar to Sidhma Kushta and pityriasis versicolor were selected .the references of the drug which has kushthagna properties, along with tikta, madhur, katu rasa pradhana dravyas were selected 1. To evaluate the efficacy of ‘Edagajadi yoga’ & “Gandhapashanadilepa’ in the management of Sidhma kushtha (pityriasis versicolor). 2. Clinical evaluation of safety of ‘Edagajadi yoga &Gandhapashanadilepa in the management of Sidhma kushtha (pityriasis versicolor). 3. To evaluate comparative efficacy of Edagajadi yoga &Gandhapashanadilepa in the management conditions similar to Sidhmakushtha & pityriasis versicolor with a controlled group of allopathic antifungal line of treatment. Study type: Interventional Randomized controlled trial Purpose: To assess the Efficacy of the trial drug Masking: Open label Timing: Prospective Endpoint: Efficacy and safety No. of group: Two Number of patients completed in the clinical trial: 50 Duration: 35 days Summary
is the short review of whole thesis work which gives us the idea about what was
the project, how it was conducted & what end results we had got
ultimately. Ayurveda, though ancient but still contemporary and
potential enough to dealing the diseases of present era. This system of
medicine has its own modes of handling a pathological condition where by the
consequences are absolutely desirable. The current research work entitled
as A Randomized controlled clinical study to
evaluate the efficacy and safety of Edagajadi yoga and Gandhapashanadi
lepa in the management of Sidhmakushta w.s.r to
pityriasis versicolor was carried out with following aims and
objectives.Present Research work has been undertaken with the following
objectives The
current project has been presented in five parts: Conceptual
study (Ayurvedic review, Modern review) Drug
review Clinical
study Discussion Summary
& Conclusion Conceptual
study: - It is further divided into following
parts-. Ayurvedic
review: - In disease review, detailed description regarding
etymological derivation, Nidana (causative factors), Purvaroopa,
Roopa (signs and symptoms) and Samprapti (pathogenesis), Sadhyasadhyata,
Chikitsa of the disease Sidhma, as per Ayurvedic view
is done with possible correlation of Sidhma and Pityriaisis
versicolor wherever applicable. Modern
review:-The section deals regarding Pityriaisis versicolor in
regard to its etymology, definition, epidemiology, classification by various
types, etiology, triggering factors, signs & symptoms, diagnosis,
investigations, differential diagnosis, complications, prevention and
management. Drug
review:-In Drug Review, the detail about the trial
drugs ‘Edagajadi yoga’ and ‘Gandhapashanadi
lepa’ from the reason of their selection and preparation of
the yoga described. Constituent of trial drugs was explained
in detail along with Ayurvedic properties, chemical
constituents, pharmacological activity & related research works. Edagajadi
yoga contain drug- Cakramrada,
Kushtha, Aragwadha, Haridra , Daruharidra, Pippali which are
collectively of Kaphavatahara property
and directly acts on the causative doshas. The drug
also has a potential property of alleviating both Kapha and Vata by Katu-
Tikta rasa and ushna veerya. Thus Kaphavatashamaka properties
of drug help in clearing the srotorodha and digestion of Ama, which
helps in facilitating jathara-agni and dhatvagni restoring
normal functions of skin. The combination of above mentioned drugs
are Kushthaghna, Kandughna, Raktashodhaka, Varnya ,Twagdoshahara,
Krimighna, Balya and Rasayana properties, which
clearly explain its mode of action in Sidhma. Gandhapashanadi
Lepa contain drugs: Gandhak,
Yavkshara, Sarshapa tail. Upon topical application, the active
principle of the Tail reaches to the deeper tissues
through Siramukha & Swedavahi srotas by
virtue of its effect it with its Sukshma & Tikshna property.
Due to its Ushna, Laghu, Ruksha properties it removes the
obstruction in Swedavahi srotas and allows the
local toxins to flow out through the Sweda, thus clearing out the
micro channels. In most of the patients Kandu was relieved
significantly due to Kusthaghna and Kandughna properties
of Yavkshara & Gandhak. In
modern terms, the individual ingredients have anti-inflammatory, anti-fungal,
hepato-protective, antibacterial, melanin regulation and blood purifier properties. A
probable mode of action of the drug was assumed based on the classical analysis
of Rasa panchaka and Dosha-vyadhi karma along
with modern pharmacology of individual drugs. Fluconazole Fluconazole is a triazole antifungal,
inhibiting cytochrome P450-dependent ergosterol. Reduced dosage is recommended in patients with chronic
hepatic or renal disease. There are no significant adverse drug interactions
and there is no significant cardiotoxicity. Ketoconazole
ointment Ketoconazole, an imidazole, is a
broad-spectrum antifungal used in the treatment of superficial and systemic
mycoses. Through inhibition of the enzyme lanosterol 14-α-demethylase,
ketoconazole disrupts ergosterol biosynthesis to limit cell function and
growth. Clinical
Study: This
section contains aims & objectives, material & methods, criteria for
selection of patients, criteria for diagnosis, laboratory investigations, plan
of treatment, criteria for assessment, vital data of the observations of all
the patients and the results obtained from the present clinical study along
with their statistical analysis Wilcoxon matched-pairs signed ranks
Test and Paired ‘t’ Test for intra group subjective
and objective parameters and Mann-whitney Test, Unpaired ‘t’ Test for
inter group comparison of subjective and objective parameters, according
to type of data. The patients
of Sidhma (Pityriasis Versicolor) were randomly selected
for the present study, from the Kayachikitsa OPD and IPD of NIA Jaipur. 50
clinically diagnosed and registered patients of Sidhma were
divided randomly into 2 groups. Each group have 25 patients. GROUP
A- Treated with Edagajadi yoga (10
gms) ) with kwatha , before meal two times in a day for 30
days and Gandhapashanadi Lepa twice in a day for
30 days, on the lesion of Pityriasis Versicolor. GROUP
B- Treated with Fluconazole tab. (oral
150mg / week) and Ketoconazole ointment twice daily for 30
days, on the lesion of Pityriasis Versicolor. Dietary
/life style restrictions:The patients were strictly advised to follow
the restrictions regarding food, food habits and life style. The aim was to
avoid the etiological factors. Observation
& Results:-The demographic data and clinical
observations tabulated. Effect on Ayurvedic and modern
symptoms is described in the form of % improvement. The obtained results and
its analysis have been given in the form of tables and graphs. The demographic
data and clinical observations were tabulated. In
the present study maximum 48% patients were in age group 16-26 years,
50 % of the patients were female & male, 78% patients from Hindu community,
52% were unmarried, maximum number of patients (28%) were found having graduate
educational status, maximum patients 60 % were discovered to be of middle
socio-economic status, maximum number of patients (48%) were students, maximum
number of patients i.e (52%) were having this disease with a
chronicity of 1-3 years, maximum number of patients (72%) had gradual onset,
maximum number of patients (99%) suffered more itching in lesion in summer,
maximum number of patients (88%) in this study were having shweta
varna (hypopigmented lesions) type of Sidhma,
maximum number of patients (25.27%) had lesions on chest, maximum 64% patients
were mixed type of diet, maximum number of patients (58%) were
having disturbed sleep. In
the present study the data reveals that maximum 52% patients were having Vatakaphaja
prakriti, maximum number of patients (78%) were of madhyama sara,
72% were of madhyama samhanana and 68%
patients were of madhyama pramana, maximum number of patients
(66%) from madhyama satmya, maximum number of the patients
(68%) were having madhyama satva, 78% patients were having madhyama
ahara shakti, 66% were having madhyama jarana shakti, 62%
patients were having madhyama vyayama shakti. Results
in the patients of Group A:In Group A, patients were treated
with Edagajadi yoga (kwath) in a dose of 10gm
two times in a day before meal and Gandhapashanadi lepa for
local application twice in a day, showed highly significant results (p value
: P < 0.01, P < 0.001, P<0.0001) in following subjective
parameters; Kandu, Mandala, Size of lesion,
Vaivarnyata, Raji, Area of involvement, Hamilton
depression scale with percentage relief of 38%, 33%, 28.6%, 15.6%, 57.3%, 19%,
75.81% respectively. Objective
parameters- TLC, Serum creatinine showed highly
significant result with giving (percentage of decrease) an
improvement of 20.31%, 13.04%. SGOT, SGPT, Hb %, Eosinophil, KOH Mount shown
significant result of 8.33%, 10.07%, 2.49%, 11.64%,16% respectively. ESR, RBS,
Blood Urea have shown no significant result. Results
in the patients of Group B:In Group B, highly significant results (p
value: P < 0.01, P < 0.001, P<0.0001) obtained in subjective
parameters like; Kandu, Mandala, Size of lesion,
Vaivarnyata, Raji, Hamilton depression scale with percentage
relief of 18%,20%, 22.6%, 9.88%, 36%%, 43.9% respectively. Area of involvement
showed significant result (p value <0.05) with percentage relief of 4.67%. Discussion:-In
Discussion, the entire outcome of research was critically analyzed for logical
explanation and evaluation of the evidences base on the effect of the test
drugs on the selected disease.Under this heading, the total studies in concise
along with the results obtained after administration of regimen is stated. The
probable mode of action of the Shamana therapy ‘Edagajadi
yoga’ and ‘Gandhapashanadi lepa’ as a whole in the
management of Sidhma is discussed. The
main logic behind the actions is: The ushna
veerya has kaphavatahara properties neutralize
the doshika pathogenesis. Deepana-pachana
karma- neutralize ama Rasayana,
jivaniya, balya properties improve Vyadhikshamatwam to
fight against disease. The Dosha-prashamana effect acts
on the main doshas which contribute to the Samprapti viz. Kapha and Vata. The Vyadhi
prashamana effect acts on the main vyadhi by Kushthaghna, Kandughana prabhava of
the drugs. In
contemporary parlance, the anti-inflammatory, hepato-protective, blood purifier
activity, a probable anti-fungal and antibacterial activity respond
the result of cardinal symptoms.
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