A RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY& SAFETY OF “EDAGAJADIYOGA & GANDHAPASHANADI LEPA†IN THE MANAGEMENT OF SIDHMA KUSHTHA W.S.R TO PITYRIASIS VERSICOLOR

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 â€˜Edagajadi yoga’ & “Gandhapashanadilepa’ in the management of Sidhma kushtha (pityriasis versicolor).

2. Clinical evaluation of safety of â€˜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

Summaryis the short review of whole thesis work which gives us the idea about what wasthe project, how it was conducted & what end results we had gotultimately. Ayurveda, though ancient but still contemporary andpotential enough to dealing the diseases of present era. This system ofmedicine has its own modes of handling a pathological condition where by theconsequences are absolutely desirable. The current research work entitledas A Randomized   controlled clinical   study toevaluate the efficacy and safety of Edagajadi yogaand Gandhapashanadilepa in the management of Sidhmakushtaw.s.r topityriasis versicolorwas carried out with following aims andobjectives.Present Research work has been undertaken with the followingobjectives

Thecurrent project has been presented in five parts:

Conceptualstudy (Ayurvedic review, Modern review**)**

Drugreview

Clinicalstudy

Discussion

Summary& Conclusion

Conceptualstudy**: -** It is further divided into followingparts-.

Ayurvedicreview: - In disease review, detailed description regardingetymological derivation, Nidana (causative factors), Purvaroopa,Roopa (signs and   symptoms) and   Samprapti(pathogenesis), Sadhyasadhyata,Chikitsa of the disease Sidhma, as per Ayurvedic viewis done with possible correlation ofSidhma andPityriaisisversicolor wherever applicable.

**Modernreview:-**The section deals regarding Pityriaisis versicolor inregard to its etymology, definition, epidemiology, classification by varioustypes, etiology, triggering factors, signs & symptoms, diagnosis,investigations, differential diagnosis, complications, prevention andmanagement.

Drugreview**:-**In Drug Review, the detail about the trialdrugs **‘*Edagajadi yoga’***and **‘*Gandhapashanadilepa’***from the reason of their selection and preparation ofthe yoga described. Constituent of trial drugs was explainedin detail along with Ayurvedicproperties, chemicalconstituents, pharmacological activity & related research works.

Edagajadiyogacontain drug- Cakramrada,Kushtha, Aragwadha, Haridra , Daruharidra, Pippali whicharecollectively of Kaphavatahara property and directly acts on the causative doshas. The drugalso has a potential property of alleviating both KaphaandVataby Katu-Tikta rasaandushna veerya. Thus Kaphavatashamaka propertiesof drug help in clearing the srotorodha and digestion of Ama, whichhelps in facilitating jathara-agni and dhatvagnirestoringnormal functions of skin. The combination of above mentioned drugsare Kushthaghna, Kandughna, Raktashodhaka, Varnya ,Twagdoshahara,Krimighna, Balyaand Rasayana properties, whichclearly explain its mode of action inSidhma.

GandhapashanadiLepacontain drugs: Gandhak,Yavkshara, Sarshapa tail.Upon topical application, the activeprinciple of the Tail reaches to the deeper tissuesthrough Siramukha & Swedavahi srotas byvirtue of its effect it with its Sukshma & Tikshna property.Due to its Ushna, Laghu, Ruksha properties it removes theobstruction in Swedavahi srotas and allows thelocal toxins to flow out through the Sweda, thus clearing out themicro channels. In most of the patients Kandu was relievedsignificantly due to KusthaghnaandKandughna propertiesof Yavkshara & Gandhak.

Inmodern terms, the individual ingredients have anti-inflammatory, anti-fungal,hepato-protective, antibacterial, melanin regulation and blood purifier properties.Aprobable mode of action of the drug was assumed based on the classical analysisof Rasa panchaka and Dosha-vyadhi karma alongwith modern pharmacology of individual drugs.

FluconazoleFluconazole is a triazole antifungal,inhibiting cytochrome P450-dependent ergosterol. Reduced dosage is recommended in patients with chronichepatic or renal disease. There are no significant adverse drug interactionsand there is no significant cardiotoxicity.

KetoconazoleointmentKetoconazole, an imidazole, is abroad-spectrum antifungal used in the treatment of superficial and systemicmycoses. Through inhibition of the enzyme lanosterol 14-α-demethylase,ketoconazole disrupts ergosterol biosynthesis to limit cell function andgrowth.

ClinicalStudy:

Thissection contains aims & objectives, material & methods, criteria forselection of patients, criteria for diagnosis, laboratory investigations, planof treatment, criteria for assessment, vital data of the observations of allthe patients and the results obtained from the present clinical study alongwith their statistical analysis Wilcoxon matched-pairs signed ranksTest andPaired ‘t’ Testfor intra group subjectiveand objective parameters andMann-whitney Test, Unpaired ‘t’ Testforinter group comparison of subjective and objective parameters,  accordingto type of data.

The patientsof Sidhma(Pityriasis Versicolor) were randomly selectedfor the present study, from the Kayachikitsa OPD and IPD of NIA Jaipur.

50clinically diagnosed and registered patients of Sidhma weredivided randomly into 2 groups. Each group have 25 patients.

**GROUPA-Treated with Edagajadi yoga(10gms) ) withkwatha, before meal two times in a day for 30days and Gandhapashanadi Lepatwice in a day for30 days, on the lesion of Pityriasis Versicolor.

**GROUPB-**Treated with Fluconazole tab. (oral150mg / week) and Ketoconazoleointment twice daily for 30days, on the lesion of Pityriasis Versicolor.

**Dietary/life style restrictions:**The patients were strictly advised to followthe restrictions regarding food, food habits and life style. The aim was toavoid the etiological factors.

Observation& Results**:-**The demographic data and clinicalobservations tabulated. Effect on Ayurvedic and modernsymptoms is described in the form of % improvement. The obtained results andits analysis have been given in the form of tables and graphs. The demographicdata and clinical observations were tabulated.

Inthe present study maximum 48% patients were in age group  16-26years,50 % of the patients were female & male, 78% patients from Hindu community,52% were unmarried, maximum number of patients (28%) were found having graduateeducational status, maximum patients 60 % were discovered to be of middlesocio-economic status, maximum number of patients (48%) were students,maximumnumber of  patients i.e (52%) were having this disease with achronicity 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 shwetavarna(hypopigmented lesions)type of Sidhma,maximum number of patients (25.27%) had lesions on chest, maximum 64% patientswere mixed type of diet, maximum number of patients (58%)  werehaving disturbed sleep.

Inthe present study the data reveals that maximum 52% patients were having Vatakaphajaprakriti, 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 madhyamaahara shakti, 66% were having madhyama jarana shakti, 62%patients were having madhyama vyayama shakti.

**Resultsin the patients of Group A:**In Group A, patients were treatedwith  Edagajadi yoga (kwath)inadoseof10gm two times in a day before meal and Gandhapashanadi lepaforlocal application twice in a day, showed highly significant results (p value:  P < 0.01,  P < 0.001, P<0.0001) in following subjectiveparameters; Kandu,*Mandala, Size of lesion,Vaivarnyata, Raji,*Area of involvement,Hamiltondepression scale with percentage relief of 38%, 33%, 28.6%, 15.6%, 57.3%, 19%,75.81% respectively.

**Objectiveparameters-**TLC, Serum creatinine showed highlysignificant result with giving (percentage of decrease) animprovement of 20.31%, 13.04%. SGOT, SGPT, Hb %, Eosinophil, KOH Mount shownsignificant result of 8.33%, 10.07%, 2.49%, 11.64%,16% respectively. ESR, RBS,Blood Urea have shown no significant result.

**Resultsin the patients of Group B:**In Group B, highly significant results (pvalue:  P < 0.01, P < 0.001, P<0.0001) obtained in subjectiveparameters like;Kandu,Mandala, Size of lesion,Vaivarnyata, Raji,Hamilton depression scale with percentagerelief of 18%,20%, 22.6%, 9.88%, 36%%, 43.9% respectively. Area of involvementshowed significant result (p value <0.05) with percentage relief of 4.67%.

**Discussion:-**InDiscussion, the entire outcome of research was critically analyzed for logicalexplanation and evaluation of the evidences base on the effect of the testdrugs on the selected disease.Under this heading, the total studies in concisealong with the results obtained after administration of regimen is stated. Theprobable mode of action of the Shamanatherapy â€˜Edagajadiyoga’ and ‘*Gandhapashanadi lepa’*as a whole in themanagement of Sidhmais discussed.

Themain logic behind the actions is:

The ushnaveeryahaskaphavataharapropertiesneutralizethe doshika pathogenesis.

Deepana-pachanakarma- neutralize ama

Rasayana,jivaniya, balya properties improveVyadhikshamatwamtofight against disease.

The Dosha-prashamana effect actson the main doshaswhich contribute to the Sampraptiviz.  KaphaandVata.

TheVyadhiprashamana effect acts on the main vyadhibyKushthaghna, Kandughana prabhava ofthe drugs.

Incontemporary parlance, the anti-inflammatory, hepato-protective, blood purifieractivity, a probable anti-fungal and antibacterial activity respondthe result of cardinal symptoms.