Impact factor: 0.3397/ICV: 4.10 103 Pharma Science Monitor 7(1), Jan-Mar 2016 PHARMA SCIENCE MONITOR AN INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES Journal home page: http://www.pharmasm.com CLINICAL EVALUATION OF DHATRYADI KWATHA AND MANAHSHILADI LEPA AFTER VIRECHANA IN SHVITRA (VITILIGO) Nilesh L. Patel 1*, Nilesh M. Patel 2, Hasmukh R. Jadav 3, Anup B. Thakar 4 1 Ph.D. Scholar, Department of Panchkarma, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India. 2 Assistant professor, Shri O.H.Nazar Ayurveda College, Surat 2 Ph.D Scholar, Department of Rasashastra and Bhaishajya Kalpana, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India. 4 I/C Head of Department, Department of Panchakarma, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India. ABSTRACT Vitiligo is a condition that causes depigmentation of sections of skin. It occurs when melanocytes (the cells responsible for skin pigmentation) die or unable to function. It is one of the oldest and commonest skin disorders affecting approximately 1-2% of the human population. Shvitra mentioned in Ayurveda can be compared with Vitiligo caused by various dietetic and behavioral factors. Some Ayurvedic drugs are well known for the regeneration of melanocytes. The present study was planned to evaluate clinical efficacy of Dhatryadi Kwatha and Manahshiladi Lepa after Virechana in Shvitra. Total 15 registered patients (n=15) were treated with Dhatryadi Kwatha internally and Manhshiladi Lepa externally after Virechana. Assessment was done after 2 months with weekly follow-ups. Significant improvement was found in Size of patches, Colour of patches, Number of patches, Percentage of body area involvement and VASI Score after treatment of two months. On the basis of results and observations, it can be concluded that Ayurvedic formulation Dhatryadi Kwatha and Manahshiladi Lepa after Virechana are efficacious in cases of Shvitra. KEYWORDS: Dhatryadi Kwatha, Manahshiladi Lepa, Shvitra, Virechana, Vitiligo. INTRODUCTION Vitiligo is a pigmentation disorder with complex causes. De pigmented patches appear on the skin, hair, mucous membranes and the retina. It can begin at any age, but in about 50% of the patients, it starts before the age of 20. 1 Vitiligo is one of the oldest and commonest skin disorders affecting approximately 1-2% of the human population. 2 Vitiligo is considered as a great social stigma as it creates an inferiority complex in the person affected, though it does not cause any pain, ulcer or discomfort. Shvitra may start at any age but usually seen in childhood at 10 years of age or in second decade of life. 3
Impact factor: 0.3397/ICV: 4.10 104 There are mainly three theories about the underlying mechanism of vitiligo, which are as follows: (i) the first theory states that nerve endings in the skin release a chemical that is toxic to the melanocytes; (ii) the second theory states that the melanocytes simply self-destruct; and (iii) the third theory is that vitiligo is a type of autoimmune disease in which the immune system targets the body's own cells and tissues. 4 Oral and topical psoralens have both been used with varying results in the treatment of vitiligo. 4 Psoraleacorylifolia (Bakuchi) is a renowned herb and is a rich source of naturally occurring psoralen. It sensitizes human skin to the tanning effect of UV and sunlight. Autoimmune destruction is one of the major causes of destruction of melanocytes. Manahshila is an arsenic compound (As 2 S 2 ) and described and used to treat immune-related disorders like for treating an autoimmune disease due to a defective apoptosis of proliferating cells of the liver, of the skin, of the immune system. 5 Hence, in the present study, both were selected to evaluate their role in controlling the symptoms of vitiligo after Shodhana (Virechana) and in the regeneration of melanocytes. MATERIALS AND METHODS This study was a clinical trial conducted in the Department of Panchakarma, I.P.G.T. & R.A. Jamnagar, after obtaining permission from the Institutional Ethical Committee. A total of 15 uncomplicated, diagnosed cases of vitiligo at quiescent stage were registered after obtaining their informed consent. Each patient was examined in detail. Routine laboratory investigations in urine, stools, and hemoglobin and FBS were undertaken in all the cases prior to starting the treatment. Inclusion criteria Patients having sign and symptoms of uncomplicated Shvitra (vitiligo), segmental or generalized, involving both of sexes in the age group 16-60 years, were registered. Exclusion criteria Patients having Chronic condition : more than 10 years All other de-pigmentory disorders. Serious cardiac, renal, hepatic diseases. Diabetes mellitus. Patches due to burning, chemical explosion etc. Located at region of Guhyanga(genital organ), Panitala (sole of palm and feet), Oshtha (lips), Aekanga (particular whole organ), Sarvanga (whole body). Patches with Raktaroma (reddish hair) & samsakta (coalescent).
Impact factor: 0.3397/ICV: 4.10 105 Any other serious systemic illness. Assessment criteria Special scoring pattern was adopted for scrutinizing the symptomatology. The score was given on the basis of Colour of patches, Number of patches, Percentage of body area and Size of patches involvement. Surface area of total body affected and size of patches The Rule of Nine described in the forensic medicine was used here for measurement of affected area of skin. The whole body was scored as per the text as per the rule of Nine, but looking to the nature of the disease, score was further specified to the organs as follows; first divide the patient into various body regions such as the arms, trunk, legs, hands and feet. Then, using the assumption that a palm of the hand is equivalent to 1% of the body surface, but in the study many lesions are within a palm area. So it is difficult to note it in palm units. In order to make the calculation it further divided the palm of the patient in to 4 parts and <¼ palm = 0.25%, ¼ to ½ palm = 0.5%, ½ to ¾ palm = 0.75%, ¾ to1palm = 1% and measurement of lesions are taken. (Table No.1) Colour of Patches Score No. of Patches Table 1 Scoring pattern for Vitiligo Score % of body area Score Size of Patches Normal Skin color 1 1 1 1% 1 1cm 1 Red colour 2 2 2 2% 2 2 cm 2 White to reddish 3 3 3 3% 3 3 cm 3 Red to whitish 4 4 4 4% 4 4 cm 4 White 5 >4 5 >4% 5 >4 cm 5 Color of patches Score Normal Skin color, Red colour, White to reddish, Red to whitish and White colour of skin is given score. (Table No.1) No. of patches How many patches on the body is counted and given score. (Table No.1) Total score was obtained from calculation of Table No.1 and Maximum score was 20. Then they were divided into mild, moderate and severe category (Table No.2) Table 2 Total score for assessment Category Total Score Mild 1 to 7 Moderate 7 to 14 Severe 14 to 20
Impact factor: 0.3397/ICV: 4.10 106 Duration of trial Total duration was 2 months, with bi-weekly follow-ups. Follow-up and assessment All the subjects were evaluated bi-weekly for 2 months. Efficacy of trial drug was assessed by improvement in signs and symptoms. (Table No.3) Table 3 Overall effect of therapy Percentage Effect of therapy 0 25 No change 26 50 Mild improve 51 75 Moderate improve 75 99 Marked improve 100 Cured Statistical analysis For analysis here used unpaired "t"-test to see the effect of drug from baseline to different follow-ups in quantitative and qualitative variables, respectively. Treatment Schedule Schedule for Virechana Procedure Drug & dose Duration Dipana&Pachana TrikatuChurna 3 gm twice a day 3-5 days Snehapana Cow s ghee 3-7 days Abhyanga&Svedana Balataila 3 day Virechana Karma Trivritadiyoga as per Koshtha (25-50 gms) 1 day SamsarjanaKrama Diet as per Shuddhi 3-7 days Schedule after Virechana Procedure Drug & dose Duration DhatryadiKwatha 6 ManhshiladiLepa 7 40ml/day into two divided doses External application in Q.S. once a day 6 weeks 6 weeks
Impact factor: 0.3397/ICV: 4.10 107 Observations Of the registered patients, 6 were in the age group of 16 30 years. Majority of the registered patients (08) were females, 7 had positive family history. Totally,11 patients had white coloured patches while 3 patients had red to white and only one patient had red coloured patch. A total of7 patients had number of patches more than 4;while 4 patients had 4 patches, 3 and 2 patches were found in 3 and 1 patient each. Totally, 3 patients had more than 4 cm size of patches, 1 patient had 4 cm, while 1 patient had 3 cm size of patches, 8 patients had 2 cm and only 2 patients had 1 cm size of patches. Vata Kaphaja Prakriti was predominant in the majority of the patients. Haematological and biochemical investigations after the treatment were within normal limits. RESULTS Effect of therapy shows that in 56.16% reduction was found in colour of patches, in number of patches 45.16%reduction was found while in percentage area of patches 48.84%reduction was found and 37.50% reduction was found in size of patches and 52.78% reduction was found in VASI score. All these changes were statistically highly significant (P < 0.001) [Table 4]. Based on this, it can be said this therapy is useful in cases of Shvitra. Table 4 Effect of therapy on main symptoms Sign & Mean Mean % S.D.± S.E.± t p Symptoms B.T. A.T. Diff. change of Patches Colour 4.87 2.13 2.73 56.16 0.80 0.21 12.76 <0.001 Number 4.13 2.27 1.87 45.16 0.89 0.24 7.82 <0.001 Area 2.87 1.47 1.40 48.84 0.74 0.20 7.03 <0.001 Size 2.67 1.67 1.00 37.50 0.92 0.25 4.08 <0.01 VASI 2.40 1.13 1.27 52.78 1.29 0.35 3.67 <0.01 DISCUSSION In the Ayurvedic system of medicine, Khadira and Bakuchi (P. corylifolia) seeds are used for the treatment of vitiligo. Psoralens have been used as topical and systemic applications for vitiligo since decades. 8 In clinical trial the initial response to treatment was erythema of the lesion in all cases, while itching and blister formation was observed in the 20% of cases. For the blisters, application of ghee or coconut oil was prescribed. After few days, erythema was followed by repigmentation. The repigmentation was fast with in mild severity of patches, but it was delayed in patients who had severe category of patches. Best results were obtained in patients who follow Pathyapathya. However, in Hb, ESR, WBC, Neutrophils, Lymphocytes, Monocytes and
Impact factor: 0.3397/ICV: 4.10 108 Eosinophils changes were within normal biological ranges shows statistically non-significant (p>0.05). While FBS was (11.43%) decreased which is statistically significant (p<0.01). Among the main ingredients of Dhatryadi Kwatha and Manahshiladi lepa, Khadira and Amalaki have Vyadhipratyanika effect and in Charaka Samhita both are mentioned in Kushthaghna Mahakashaya. 9 Bakuchi has been extensively used by all the Ayurvedic scholars in hypopigmentation with great success. It contains psoralens, which on exposure to the sun bring out melanin in the depigmented lesions. Amalaki, is a potent drug with antimicrobial, antioxidant, immunomodulatory, antifungal, hypoglycaemic, anti-inflammatory, antibacterial, antiulcer, adrenergic potentiating property. 10 Here, its role is to protect the skin from the irritating effects of Bakuchi and as an emollient. Manahshila, an arsenic compound, was used in the Lepa. This was selected on the basis of its reference in Rasa Tarangini. 7 Arsenic is absorbed through skin in addition to other routes. In Shvitra, the deranged immune system destroys the pigment synthesizing melanocytes. Manahshila breaks this pathogenesis and prevents the self-destruction of melanocytes. Apamarga has Rakta-Pitta Prasadanakara action. 11 Apamargakshara is alkaline in nature and in shvitraksharakarma is indicated.. 12 The impact of decoction and Lepa was studied on liver and was assessed by the eosinophils %, in which changes were within normal biological ranges. Bakuchi and Manahshila have no toxic effects on the body. CONCLUSION The trial drugs provided significant results against size, colourand number of patches. Considering the encouraging results, itcan be said that the drugs after Virechana can be successfully used in cases of Shvitra. However, the observations can be revalidated throughwell designed clinical trials involving larger sample size. REFERENCES 1. Harrison's - Principles of Internal Medicine, Braunwald, Kasper et al. 17 th ed. Vol. 1. New York: McGraw Hill; 2008 Part-7, Section 54, pg. 324-6. 2. Lerner AB, Vitiligo, J Invest Dermatol, 1959;32:285-310. 3. Valia R G, Textbook and Atlas of Dermatology, Bhalani Publishing, Bombay, 1 st ed. 1994, Vol. 1 pg. 518 519 4. Njoo md, Westerhof W, Vitiligo, Pathogenesis and treatment. AmJClinDermatol 2001; 2: 167-81. 5. http://www.google.com/patents/ep1499330b1 (last seen 24-3-2013) 6. Chakrapanidatta, Chakradatta, 49/72 by Vaidya RavidattaShastri, ChaukhambaSurbharati, Prakashana,Varanasi, 2006, pg 196.
Impact factor: 0.3397/ICV: 4.10 109 7. Sadananda Sharma, Rasatarangini 14/71, MotilalBanarasidas Publication 2000, Delhi, pg.339 8. Anonyms, Database on Medicinal Plants Used in Ayurveda, Published by The central council of Research in Ayurveda & Siddha, Volume 2,New Delhi, 2001. 9. AacharyaAgnivesha, Charaka Samhita Sutrasthana 4/11by Vaidya Yadavaji Trikamji, Chaukhambha subharati prakashan, Varanasi 2011, pg 32-33 10. Anonyms, Database on Medicinal Plants Used in Ayurveda,Published by The central council of Research in Ayurveda & Siddha, Volume 2, New Delhi, 2001, 11. Shri Bhava Mishra, BhavaPrakashaNighantu, GuduchyadiVarga, By Shri Bhramhashankara Mishra and Shri RupalalajiVaishya, 11 th ed. Chowkhamba Sanskrit Sansthan, Vaanasi, 2004, Pg 414-416 12. Acharya Shusruta, Shusruta samhita Sutrasthana 11/7, by VaidyaYadavajiTrikamji, Chaukham bhasubharati prakashan, Varanasi, 2010, pg 46. For Correspondence Nilesh L. Patel Email: dr.nilesh.ayu@gmail.com