original reasearch article - clinical...

Journal of Ayurveda Official publication of National Institute of Ayurveda, Jaipur, Rajasthan50

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ORIGINAL REASEARCH ARTICLE - CLINICAL STUDY

A Study on Efficacy of Virechana and Gajalinda Kshara on Shwitra w.s.r. to Vitiligo (Leucoderma)

*Dr. Surendra kumar Sharma, **Dr.Shrinidhi K.Acharya, *** Dr. Piyush Mehata*Medical Officer, APHC, Pragapura, Jaipur, **Assistant Professor, ***Ex. Professor, Dept. of Kaumarabhritya, National Institute of Ayurveda,

Jaipur.

ABSTRACTObjectives: - A Study on Efficacy of Virechana and Gajalinda Kshara on Shwitra w.s.r. to Vitiligo (Leucoderma)

Design: interventional, open label masking, randomized trial, Setting:- Hospital based Participants:- children of age group 5-15 yrs. Intervention:- Gajlindalepa and Virechana with Gajalindalepa in two groups A & B for advised to apply the trail drug Gajlindalepa provided to them at early morning preferably at the time of sun- rise hours once in day for the duration of six months for patients were followed-up on every fifteen days. Outcome measures:- Clinical Features- no. of black spot in observed patch, color change in the observed patch, reducing size of the observed patchResults: - Highly significant improvement in both the groups Conclusion:-Both the trial drugs are effective in the management of Shwitra but Virechana with Gajalindalepa is more effective than Gajalindalepa without Virechana.

Address of Correspondence: Dr. Surendra Kumar SharmaMedical Officer (AYUSH), APHC, Pragapura, Jaipur.

Email ID : [email protected]

Contact No : 8209389214

How to Site the Article : Sharma SK, Acharya SK, Mehata P, A Study on Efficacy of Virechana and Gajalinda Kshara and Mutra on Shwitra w.s.r. to Vitiligo (Leucoderma), JOA XIII-3, 2019; 50 - 57

Keywords : Shwitra, Vitiligo, Gajalindalepa and Virechana

JOAjournalofayurveda.in ISSN No:2321-0435

Introduction

As color of the skin plays a very important role in cosmetic world and trying to be more beautiful and attractive is natural tendency of human being, although Shwitra don’t produces pain, ulcer or discomfort, but eventually creates an inferiority complex in individual which later lead to disturbances in his social, personal and educational life.

Based on the symptoms, Shwitra can be correlated with Vitiligo where we find improper distribution of melanocyte pigment (Vitiligo). Vitiligo a hypopigmentation disorder may be of genetic or acquired cause. The disease may start at any age but usually seen in child hood at 10 years of age or in second decade of life. Based on some dermatological out patient records it is roughly estimated to be between 3 – 4% in India. The Vitiligo affects the estimated 1% of world population. we find many hidden cases of Shwitra due to certain misbeliefs and myths related to this disease. Of course all the hypo pigmented cases are not Vitiligo as


Sharma SK, Acharya SK, Mehata P, A Study on Efficacy of Virechana and Gajalinda Kshara and Mutra on Shwitra w.s.r. to Vitiligo (Leucoderma), JOA XIII-3, 2019; 50 - 57

Colour of skin depends on many other factors.

But any cause which disturbs the color of skin is called as Kusta in Ayurveda. Shwitra is considered amongst the varieties of Kusta in the classics,[1] due to vitiation of Dhatus like Rasa, Rakta, Mamsa and Meda[2], Seven Dushyas, Tridoshas. Depending upon the duration of the disease and the involvement of Dhatus, the disease becomes prognostically bad. Meantime among the Raktha pradosha javikara, also Shwitra has been counted.[3]

In the present day context there is no significant and satisfactory remedy which effectively and permanently cure this disease. General public is still searching for the alternative treatment which can provide safe, effective and permanent solution for this cosmetic problem, which directly interfere with overall personality of an individual. Ayurveda explains Shwitra in detail with certain treatment principles which lit some light of hope in an attempt to provide an alternative. This study is an attempt to find an effective remedy for Shwitra based on Ayurvedic principles. In the present study in order to cure the disease from root, the Samshodhan Karma will be followed in the form of Virechana similarly Kshara prepared by Gajalinda will be applied with Gajamutra externally for discoloured patches along with internal administration of Gajamutra in a fixed dose.[4]

In the present study Virechana has been planned and internal Snehapana with Goghrita after Deepana, Pachana Chikitsa. Bahya Abhyanga will be carried out by Panchanana taila which is indicated for Shwitra.[5] A Sramsana Virechana drug Aragwadha Phalamajja has been selected for inducing Virechana as mentioned in classics. Gajamutra and Gajalinda which has been quoted for its Shwitrahara property has been taken in this study.

Drug Matrial Taken For The Study Include –

1. Bala-Chaturbhadra

2. Moorchita Goghruta

3. Panchanan Taila

4. Aragvadha Phala Majja

5. Gajlindalepa (Gajalinda kshara + Gajmutra + Bakuchi Beeja Churna)

6. Bala-Chaturbhadra:

For the purpose of the study Bala-Chaturbhadra Churna prepared from NIA Hospital, Jaipur was taken.

Moorchita Goghruta:

For the purpose of the study Murchita Goghruta prepared from NIA Hospital, Jaipur was taken.

Panchanan Taila

For the purpose of the study Panchanan Taila prepared from NIA pharmacy, Jaipur was taken.

Aragvadha Phala Majja[6]:

Aragvadha Phala Majja was taken NIA pharmacy, Jaipur and was used for the study.

Gajalinda, Gaja Mutra and Bakuchi Beeja

Churna[7]

The Gajalinda and Mutra for the preparation of Gajalinda kshara was collected personally from Hathi Ganva, Amer in Jaipur and Bukuchi Churna was supplied from NIA Pharmacy, Jaipur was used for the study. The compound of these drugs for the purpose of external application was got prepared in Bhaishajya kalpana department of NIA College Jaipur discussed in the chapter on drug review.

Grouping & Trial Of The Study

The present study was planned as interventional, open label masking, randomized trial, and patients were randomly in two groups divided as group A and group B with 15 patients in each. The cases registered for the 1 patients of group A and 2 patients of group B were dropped from study.

Group A: Treated with Gaajlind lepa.

Group B: Treated Sanshodhana (Virechana) followed by Gajlindlepa.

All patients between the age group of 5 – 15 years attending the Kaumarabhritya OPD and I P D of NIA


Hospital, Jaipur with complaints of Shwitra were taken up for the study after following the criteria laid as above. Their age, sex, religion, socioeconomic status, food habits, family history, etc. were noted as given in master chart. Where there is more than one patch of vitiligo in any patient only one patch was selected for the study. However where improvement was found in that particular patch, patient was advised to treat other patches also with the same drug. The size of the observed patch was approximately measured in square centimeters by multiplying its breadth and length.

Complete history and clinical examination of all these patients was carried out and recorded in a specially designed Performa by the Post Graduate Department of Kaumarbhrithya of NIA college of Ayurveda, Jaipur. Their findings are given in the enclosed master chart.

Mode Of Administration Of Drug:

All patients of both the groups were administered the drugs as follows –

1. Balchaturbadra Churna in a dose of 100mg/Kg body wt. twice daily with Ushnodaka as Anupana was administered before food for three days prior to Snehapana for Pachana of any existing Ama and for Agnideepana.

2. Starting from 15-3oml (According to body wt.) ml per day Moorchita Goghruta was administered for Snehana by increasing it by another 15-30ml (According to body wt.) per day until the appearance of kosta Snigdha Lakshanas as evidenced from oily and loose stools.

3. Abhyanga was then carried out with Panchanan Taila daily followed by Sarvanga Swedana (for five minutes) for three-five days.

4. 20 gram of Aragvadha Phala Majja was then administered with warm ksheera on third day after Abhyanga and Swedana, in the morning in empty stomach.

A watch was made for kosta Shuddi by observing the number of stools till after noon. After this patients of

group B were advised to apply the Gajlindalepa in the morning on the vitiligo patches with water and were advised to expose the patches to sun light for the 30 minutes. Patients of group A were also advised to apply the Gajlindalepa daily in the morning with water and were advised to expose the patches to sun light for 30 minutes because psoralin present in Bakuchi has a photosensitive action.

Duration Of The Treatment:

Patients of both the groups were advised to apply the trail drug Gajlindalepa provided to them at early morning preferably at the time of sun- rise hours once in day for the duration of six months for patients were followed-up on every fifteen days.

Diagnostic Criteria

A. Inclusion Criteria

1. Age between 5-15 years

2. Children diagnosed as Shwitra as per clinical features mentioned in Ayurvedic texts.

B. Exclusion Criteria

1. Children below 05 and above 15 years of age.

2. Children with Albinism were excluded.

3. White anesthetic spots, which are characteristic of leprosy.

4. Old refractory cases not responding after extensive use of modern medicine.

5. Patches in genital area are excluded from the study.

6. Vitiligo patches complicated by eczema.

C. Assessment Criteria:

Criteria for assessment:

A standard grading system was developed to assess the improvement in treated cases based on symptomology of the Shwitra.




Grading for no. of black spot in observed patch

1. Black spot no appear 0

2. If one to two spot appear 1

3. If three to five spot appear 2

4. If more than five spot appear 3

Grading for color change in the observed patch

1. No change in color (white spot) 0

2. Pink 1

3. Black 2

4. Normal skin Color 3

Grading for size of the observed patch

1. If size increase 0

2. If size same 1

3. 10% reducing size 2

4. More than 10% reducing size 3

Photography:- recorded periodically

Assessment Of Results

The clinical study was analyzed after the treatment for the effect of clinical features. Results of effect on clinical features by using non parametric test Wilcoxon matched Test and intergroup comparison by Mann-Whitney Test.

Parent’s Consent / Child Assent

A voluntary, signed witnessed informed consent / assent was obtained from the participant / parent’s / Guardians prior to the start of clinical trial. (Annexure- III).

IEC Approval

Clinical study was approved by IEC, order no. F10 (5)/EC/2014/7220 dated 7/11/2014.

Observations

y 11-15yrs age group was the most affected group.

y Female were more prone to Shwitra as compared to male.

y Maximum number of cases were belonging to urban area, Hindu religion, vegetarian diet, middle socio-economic status.

y Maximum numbers of cases exhibited chronicity of 1month -3 yrs, no family history.

y Maximum patients of trial were Vata-Pitta Prakriti, Mandagni, Madhyama Koshtha, Madhyama Satva.

y Maximum patients of trial were immunized and earlier treatment history present.

y Patients were found with maximum 6-10 Patches.

y Maximum patients were found with no black spot in observed patches.

y Maximum patients were found with white color patches.

y Maximum patients were found with less than 10 square cm size of lession.

Results:

Table No. I: Effect of therapy on number of black spots in both groups:

Signs Group Mean Mean difference

% Of improve

mentS.D S.E P –

value Infere

nceBT AT

Number of black spots A 0.53 1.33 0.80 60.15% 0.86 0.22 0.0078 Very

significant

Number of black spots B 0.80 2.33 1.5 64% 1.12 0.29 0.0010 Extremely

significant


Sharma SK, Acharya SK, Mehata P, A Study on Efficacy of Virechana and Gajalinda Kshara and Mutra on Shwitra w.s.r. to Vitiligo (Leucoderma), JOA XIII-3, 2019; 50 -57

Number of black spot in group A with mean score before treatment was 0.53 which was increased to 1.33 after treatment, with SD+_0.86 giving a relief of 60.15% which was statistically very significant (P value 0.0078) and In group B the mean score before treatment was 0.80 which increased to 2.33 after treatment, with SD+_1.12 giving a relief of 64% which was statistically extremely significant (P value 0.0010). Intergroup comparison P value is 0.2349 which is statistically not significant which shows that there is no statistically difference in efficacy of both treatment on black spot in observed patches.

Graph No. 1: Effect of therapy on number of black spots in both groups:

Table No. II: Effect of therapy on Color of observed patches in both groups:

Signs Group

Mean Mean difference

% Of improve

mentS.D S.E P –

value InferenceBT AT

Color of observed patches

A 0.46 1.2 0.73 60.83% 0.88 0.22 0.0078 Very significant

Color of observed patches

B 0.26 1.13 0.86 76.10% 0.91 0.23 0.0039 Very significant

Color of observed patch in group A with mean score before treatment was 0.73 which was increased to 1.73 after treatment, with SD+_0.84 giving a relief of 57.80% which was statistically extremely significant (P value 0.0010) and in group B the mean score before treatment was 0.53 which increased to 2.2 after treatment, with SD+_0.89 giving a relief of 72.72% which was statistically extremely significant (P value 0.0001). Intergroup comparison P value was 0.2825 which was statistically not significant which shows that there was no statistically difference in efficacy of both treatment on black spot in observed patches.

Graph No. 2 :Effect of therapy on Color of observed patches in both groups:



Decrease in size in group A with the mean score before treatment was 0.73 which was increased to 1.73 after treatment, with SD+_0.84 giving a relief of 57.80% which was statistically extremely significant (P value 0.0010) and in group B the mean score before treatment was 0.53 which increased to 2.2 after treatment, with SD+_0.89 giving a relief of 72.72% which was statistically extremely significant (P value 0.0001). Intergroup comparison P value was 0.2068 which was statistically not significant which shows that there was no statistically difference in efficacy of both treatment on black spot in observed patches.

Table No. III: Effect of therapy on Size of observed patches in both groups:

Signs Group Mean Mean

difference

% Of impro

vementS.D S.E P –

value Inferen

ceBT AT

Size of observed patches

A 0.73 1.73 1.00 57.80% 0.84 0.21 0.0010Extremely signifi

cant

Size of observed patches

B 0.53 2.2 1.6 72.72% 0.89 0.23 0.0001Extremely signifi

cant

Graph No. 3: Effect of therapy on Size of observed patches in both groups:

Discussion:

The effects of therapy on the symptoms of 30 patients (15 patients in each group) of Shwitra/vitiligo


Number of black spot in observed patches

In the present study the patient were evaluated for number of black spot appeared in observed patches and grading of same was done on completion of trial of six month. Very significant result (P value-0.0078) in group A with the 60.15% extremely significant (P value 0.0010) result in group with 64% has been observed. This clearly suggest the effect of trail drug at the level of skin and melanocytic cells stimulating production of melanin pigment. Appearance of blackish spots also suggests the deposition of melanin pigment secreted by melanocytes cells of skin production of which has been governed in melanocyte secreting hormones of the Pituitary and Pineal gland. This result suggests that hormonal influences of Virechana Karma in the correction of pathology.

Color changes in observed patches

In the present study the patient of the both groups were evaluated for change in color in observed patches and graded at the completion of trial of six month. After statistical analysis very significant result (P value-0.0078) was obtained in group A with the 60.83% relief and very significant (P value 0.0039) result with 76.10% relief in group B. After administration of the trail drug the whitish patches turn pink within few days followed by appearance of blackish spots. This process is faster in group B, which is priory administrated with VirechanaKarma: although both groups has shown significant results. Ushna, Teekshna property of the drug leading to irritation and increasing blood supply to the spot and correction of Bhrajakapitta might have been responsible for this. Further prior conditioning of body by Virechana, removes all the hurdles in correction of defaults in function Pitta and helps for easy correction.

Size decrease in observed patches

In the present study the patient of both groups evaluated for decrease in size of the observed whitish patches and same is graded to get a statically data at the completion of six months trial. Extremely significant result (Pvalue-0.0010) was obtained in group A with the 57.80% relief. However in group B extremely significant

(P value 0.0001) result with 72.72% relief with rapidly appearing blackish spot and color changes which may be due to prior conditioning of body by Virechana therapy. These finding suggest high efficacy of trail drug in group A i.e. Gajalindalepa on patients of Shwitra. However extremely significant results in both the groups shows effects of Shodhana (Virechana) which is best for Pitta dominant disorder, followed by Gajalindalepa in reducing the whitish patches and normalizing the skin.

Conclusion:

On the present study efficacy of Virechana and Gajalinda Kshara and-Mutra on Shwitra w.s.r. to vitiligo (leucoderma) which was interventional, open label masking, randomized trial, conducted in 30 patients equally divided in 2 groups for period six months. Following conclusions are drawn can up:

1. Shwita is Tridoshaja in nature with dominance of Pitta Dosha along with vitiation of Rakta Dhatu associated Rasa Mamsa and Meda Dhatu Dushti.

2. In the present study it is concluded that the most striking feature of Shwitra was presence of whitish patches over the skin.

3. In the present study it is concluded that certain Virudha-Aharas like Masha (Black gram), Mulaka (raddish), Dadhi (curd), Amla Rasa Sevena (sour substances) and irregular food habits are the most common causative factors for Shwitra.

4. In present study it can be concluded that correction or healing of hypo-pigmented patch usually followed by itching and appearance of blisters at the site of lesion which is, later converted in to normal pigmented patches of the skin.

5. In the present study group A treated with Gajalindalepa has showed very significant results suggesting its efficacy in normalization skin discoloration.

6. In the present study group B which is treated with Shodhana (Virechana) followed by Gajlindalepa has shown extremely significant result on reducing



symptomology of Shwitra.

7. Group B as shown extremely significant results in comparison to group A on appearance of black spot, change of color to normalization and fast reduction in the size of patches showing its high efficacy in correction of pathological changes extremely of Shwitra.

8. However advanced study with larger sample size has been recommended to draw the final conclusion.


References

1. Susruta-Samhita, By Kaviraja Abmibikadutta Shastri, A.M.S. Published By Chaukhambha Sanskrit Sansthan, Varanasi, Edition 2011 Part-1, Nidan-Sthan Chapter-5/17

2. Charaka Samhita, Gorkhanath Chaturvedi, Kasinatha Sasatri, Choukhambha Bharti Academy, Edition 2011, Chikista-Sthan 7/174, pp. 161

3. Charaka Samhita, Gorkhanath Chaturvedi, Kasinatha Sasatri, Choukhambha Bharti Academy, Edition 2011, Sutra-Sthan 28/12, pp. 701

4. Bhaishjya Ratnawali-“Sidhdiprada”, By Kaviraj Shri Govind Das Sen, Published By Chaukhamba Surabharati Prakasan Varanasi. Edition 2012 Bala Roga Chikitsa Parkaran 54/48-49

5. Bhaishjya Ratnawali-“Sidhdiprada”, By Kaviraj Shri Govind Das Sen, Published By Chaukhamba Surabharati Prakasan Varanasi,Edition 2012 Bala Roga Chikitsa Parkaran54/256-266

6. Dravyaguna-Vijnana, Prof. P.V. Sharma Published By Chaukhambha Bharati Academy, Varanasi. (Reprint-2006), Vol.-2

7. Dravyaguna-Vijnana, Prof. P.V. Sharma Published By Chaukhambha Bharati Academy, Varanasi. (Reprint-2006), Vol.-2

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