Role of Virechan Karma and Oil Application in Vitiligo
- Conditions
- Vitiligo
- Registration Number
- CTRI/2018/05/014097
- Lead Sponsor
- Uttarakhand Ayurved University
- Brief Summary
**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 ) inthe 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 willbe given in a dose of 3 to 6 gms BD asper the koshtha of patients.
**Pradhana karma -**After administration of snehana and on emptystomach after the time of Kapha has been pass Nishothadi Kwatha will be given to thepatient as per kostha of patient.
**Paschata Karma –** Patient should adviced for SansarjanaKarma as per type of Shuddi obtaine.
**Purva Karma –** Ask to the patient to wash the affected ariawith 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 moderateburning sensation afterapplication of abhayang. Blister got develop within 2 to3 days after application of oil .Till they get disappear as new skin grows .
**PLAN OF STUDY:**
***ClinicalStudy:*** For the clinical study, patients attendingOPD and IPD of the Panchkarma Department of Rishikul Campus, Haridwar.
**Total No. of Patients :** **40**
**Type of study :** openstudy
**Level of study :** O.P.D.& I.P.D. level
**Period of study** : 60 days
**FOLLOW UP:** Thefollow up will be of one month after completion of treatment to observe the effectof treatment or any adverse effects etc.
***B) INCLUSIONCRITERIA*****-**
• Vitiligowith classical signs and symptoms.
• Agegroup 15 to 70 years.
***C) EXCLUSIONCRITERIA-***
• Pregnantwomen and lactating women.
• Vitiligolinked with other disease that is Hypertension, Diabetes, Tuberculosis,Rheumatoid Arthritis, and Anemia.
• Patchesover genital areas.
• Knowncases of leprosy.
• Rapidlyspreading Vitiligo patches and associated with blisters and rubor duringtreatment.
• Vitiligopatches complicated by eczema and burns.
• Extensiveand complete dipigmented Vitiligo.
• Congenitalpigmentation disorders.
For present study minimum 40 patients will beselected on the basis of inclusion & exclusion criteria
***D) SAMPLESIZE***- 40 patients will be taken for the study
**Grouping:** Ineach 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 administrationof Virecnana dravy*.*Then,*Samsarjana karma* will be followed as pertype of *shudhhi.*
***GROUPB***: -20 patients of Shivitra will be treated with externally .
Classical virechanakarma includes Deepana ,Pachana,Snehpana, Abhyanga and Swedana administrationSanshodana 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 assessmentwill be done after 2 month to check the recurrence or any associated complainafter withdrawing the therapy .
**CRITERIA FOR WITHDRAWAL**
§ Personal Matters.
§ Aggravation of complaints.
§ Inter-current illness.
§ Any otherdifficulties.
§ Leave against medical advice (LAMA).
**OBSERVATION &ASSESSMENT:**
Observationwill be carried out at interval of 15 days for 60 days.
Observationof patient will be carried out before, during and after the treatment.
Patientswill be evaluated for severity of illness during and after the interventionbased on parameters and investigations.
· Any addition or exclusionmay be included as necessity of the study.
Assessmentwill be done statistically.
**ResearchProforma****:****:**A detailed research Proforma will beprepared incorporating all the points from *Ayurvedic* as well as modernaspect to study the patients as well as disease.
**CRITERIA FORASSESSMENT**
} Theimprovement in patients will be asses on the basis of relief in sign andsymptoms of the disease. All the signs symptoms were givenscoring depending upon their severity to assess the effect except VASI Whichwas directly calculated by using the formula (VASI= HAND UNITS]×[RESIDUAL DEPIGMENTION])after each visit of the patient for better assessment of the trial methodologyused.**Color -**
} Normalskin color – 0
} Redcolor – 1
} RedPale – 2
} Palewhite – 3
} **Margin**
} Normalskin color attributed. – 0
} Hyper-pigmentedthick broad with graduated margin. –1
} Hyper-pigmentedbroad with graduated margin. – 2
} Hyper-pigmentedwell defined margin. – 3
} Hyper-pigmentedthin edge margin. – 4
} Welldefined margin. –5
Signsand symptoms
**Color-;**
Normalskin color – 0
Redcolor – 1
RedPale – 2
Palewhite – 3
**Margin;**
Normalskin color attributed. – 0
Hyper-pigmentedthick broad with graduated margin. – 1
Hyper-pigmentedbroad with graduated margin. – 2
Hyper-pigmentedwell defined margin. – 3
Hyper-pigmentedthin edge margin. – 4
Welldefined margin. –5
**INVESTIGATIONS**:
o Hb%Waist
o circumference(ininches)
o T.L.C
o D.L.C
o Randomblood sugar.
o Waistcircumference(in inches)
o Totalcholesterol/HDL
o HDL/LDL.
o Erythrocytesedimentation rate (ESR).
Theseinvestigations will be carried out before and after completion of therapy.
**STATISTICAL ANALYSIS:**.
To obtain the efficacy ofthe therapy on Objective parameters, properstatistical analysis will be cerried out of available data.
1. Within the groupparametric by – t- paired.
2. Within the group non-parametric by Wilcoxon test.
3. Inter groupparametric by Chi- squared.
4. Inter groupnon-parametric by Mann- Whitney U test.
**CONCLUSION:**
Theresult will be analyzed statistically and discussed. Conclusion will be made onthe basis of the observation which is done on subjective parameters.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 40
Classical Sign of Vitiligo.
Complicated Condition.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Marked improvement :76% to 100% •Marked improvement :76% to 100% | •Moderate improvement:51% to 75 % | •Mild improvement :26 % to 50 % | •No improvement : 0% to 25 % •Moderate improvement:51% to 75 % •Marked improvement :76% to 100% | •Moderate improvement:51% to 75 % | •Mild improvement :26 % to 50 % | •No improvement : 0% to 25 % •Mild improvement :26 % to 50 % •Marked improvement :76% to 100% | •Moderate improvement:51% to 75 % | •Mild improvement :26 % to 50 % | •No improvement : 0% to 25 % •No improvement : 0% to 25 % •Marked improvement :76% to 100% | •Moderate improvement:51% to 75 % | •Mild improvement :26 % to 50 % | •No improvement : 0% to 25 %
- Secondary Outcome Measures
Name Time Method •Marked improvement :76% to 100% •Moderate improvement:51% to 75 %
Related Research Topics
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Trial Locations
- Locations (1)
Rishikul campus Hospital
🇮🇳Hardwar, UTTARANCHAL, India
Rishikul campus Hospital🇮🇳Hardwar, UTTARANCHAL, IndiaDr Sanjay GuptaPrincipal investigator9411754007ayursanjay44@gmail.com