Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore s32

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE

COMPLETED PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION IN M.D (AYURVEDA)

“CLINICAL STUDY ON THE ROLE OF MAHATIKTAKA GHRUTHA AND JEEVANTHYADI YAMAKA IN THE MANAGEMENT OF EKAKUSHTA WITH SPECIAL REFERENCE TO ICHTHYOSIS VULGARIS IN CHILDREN.

BY Dr. NIVYA P. THOMAS DEPARTMENT OF P.G. STUDIES IN KOUMARABHRITYA S.D.M. COLLEGE OF AYURVEDA HASSAN-573201

Dr.SHAILAJA .U,MD (Ayu), Phd. HEAD OF THE DEPARTMENT DEPT OF KOUMARABHRITYA S.D.M. COLLEGE OF AYURVEDA HASSAN-573201

S.D.M. COLLEGE OF AYURVEDA AND HOSPITAL B.M. ROAD, THANNIRUHALLA, HASSAN-573201 2012-2013

From, Dr.NivyaP Thomas, Department of Post Graduate Studies in koumarabhritya, S.D.M. College of Ayurveda and Hospital, Hassan- 57320

To, The Registrar, Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka.

Through, The Principal and Head of the department of Kaumarabhritya, S.D.M College of Ayurveda and Hospital, Hassan- 573201. Subject: Submission of completed Proforma for Registration of subject for Dissertation. Respected Sir, I request you to kindly register the below mentioned subject against my name for the submission of dissertation to the Rajiv Gandhi University of Health Sciences, Karnataka, and Bangalore for partial fulfillment of M.D (Ayu).

Title of the Dissertation: “CLINICAL STUDY ON THE ROLE OF MAHATIKTHAKA GHRITHA AND JEEVANTHYADI YAMAKA IN THE MANGEMENT OF EKAKUSHTHA WITH SPECIAL REFERENCE TO ICHTHYOSIS VULGARIS IN CHILDREN.” Herewith I am enclosing completed Performa for Registration of Subject of dissertation. Thanking you,

Yours faithfully, Date: Place: HASSAN ( Dr.Nivya P. Thomas)

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORES ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. NAME & ADDRESS OF : DR. NIVYA P THOMAS CANDIDATE PRELIMINARY M.D. (AYU.) SCHOLAR

DEPARTMENT OF P.G. STUDIES IN KAUMARABHRITYA S.D.M. COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN-573201.

PERMANENT ADDRESS : D/O THOMAS MATHEW PULIKEEL HOUSE MULAKULAM (N), PO PIRAVOM ERNAKULAM (DISTRICT) PIN CODE-686664,KERALA

2. NAME OF THE INSTITUTE : S.D.M. COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN, KARNATAKA

3. COURSE OF STUDY AND : M.D. (AYU.) IN KAUMARABHRITYA SUBJECT. 4. DATE OF ADMISSION TO : 09/10/2012 THE COURSE: 5. TITLE OF THE TOPIC :

“CLINICAL STUDY ON THE ROLE OF MAHATIKTHAKA GRITHA AND JEEVANTHYADI YAMAKA INTHEMANAGEMENT OF EKAKUSHTHA WITH SPECIAL REFERENCE TO ICHTHYOSIS VULGARIS IN CHILDREN.”

6.BRIEF RESUME OF INTENDED WORK

6.1 Need for the study Childhood dermatoses can have a confusing and disruptive impact on the children as well as their parents. The stress of skin disorders often lead to anxiety, negativism, with drawl, resentment of parents, fear and other adverse psychological reactions. They have a significant impact on the quality of life, interfering with sleep, school performance and activities, interactions with other children etc. In AyurvedaTwak vikara is described in the context of kushta.The three vitiated doshas- Vatha, Pitta and Kapha in turn vitiate the Twak, Rakta, Mamsa and Ambu these taken together, constitute the seven fold pathogenic substance of kushta1.Depending upon the permutation and combination of the various fractions of Dosha there are seven types of Maha Kushta which are Asadhya and 11 types of KshudraKushta. Ekakushta is described by Charaka in eleven Kshudrakushta.2 The symptoms are Aswedanam, Mahavasthu, Matsya shakalopamam and hence the comparison with Icthyosis vulgaris is more rational as they are a heterogeneous group of dermatoses characterised by the presence of fish- like scale.

The prefix “ Ichthy” is taken from the Greek word for fishand Vulgaris is Latin for “common”and is the most common of the Ichthyosis.3Each year more than 16,000 babies are born with some form of Ichthyosis. The disease usually presents at birth, or within the first year, and continues to affect the patient throughout their life time. The scaling worsens in winter.4Thescale is whiteor grey, small, flaky and semi-adherent with turned up edges. Due to poor skin defences and dryness, patients are prone to develop pyodermas, fungal infection, eczemas and folliculitis.5

The modern treatmentmodalities includes hydration, lubrication and application of keratolytic agents to relieve the dryness and itching and to reduce the tendency of skin fissuring.Regular emollient application may be in the form of aqueous cream for mild to moderately affected patient or in the form of paraffin based or cetyl and stearyl alcohol containing emollients and oils for severely affected ones.6Application of keratolytic agents like urea, propylene glycol, salicylic acid dehiscence of scales but the possibility of systemic toxicity due to lack of barrier function of the skin limit their use in infants and young children.7

Charaka in Kushtadhikara the prime treatment methodology mentioned for Vathadosha is sarpipanam8 and Mahatikthaka grutha does the amapachana andimprovest he Agni. Ingested Grutha suppresses Pitta and Vayu, prevents accumulation of Kapha and is indicated for children.9JeevanthyadiYamaka is mainly indicated in Ekakushta and is in the consistency of emollients. So the present study is a search of finding effective palliative treatment for Ichthyosis which can be used in infantile and Pediatric age group.

6.2 REVIEW OFLITERATURE The prodromal features of Kushta is reviewed from Kashyapa as Swederaswedanam, Athikharatwa, Athislakshanatha, Vaivarnyam, Roukshyam, Lomaharshaetc.10The Shonitha Shukra dushti mentioned as one of the etiology focus towards the genetic predisposition of the disease.

Those which is vitiated by Twak, Raktha and Mamsa and with the predominance of Vatha and Kapha are Sadhya.11The area of spread is mentioned in Charaka samhitha as Mahavashtu, appearance of Matsyasakalavathu, and Aswedanam shows close resemblance with Ichthyosis.The doshic predominance had reviewed from Charaka andSusrutha, Charaka opines it as Vatha Kaphaja12 and Susrutha as Kaphaja.13Kashyapa describes as it is Visarpodhbhavam, with srava, vedana and krimimadh.14Bhela’s opinion is similar to that of Kashyapa that which is Vikunam, Saparisrava, infused all over(Samparikartanam) and with erysipelas15. Here Visarpodhbhavam (spreading out like visarpa) stated by the two authors conveys the wide spread nature of the disease.

Ichthyosis Vulgaris is an autosomal dominant disorder of keratinization and comes in the category of primary ichthyosis16.Filagrin is absent in involved skin, and the m-RNA for pro filaggrin is unstable.17The pathogenesis is hyperkeratosis results from abnormal retention of the cells of the horny layer. It is more pronounced on the extensor surfaces of the arms and lower legs, and characteristically spares the flexural creases and has a fluctuant course. Impaired keratohyaline granule synthesis (filaggrin synthesis), keratosis pillaris and dermatoglyphic accentuation are the markers for ichthyosis vulgaris18.

Mahatiktaka grutha is mentioned in the context of Kushtadhikara and is rewiewed from the classical treatise. It contains Saptaccada, Parpata, Shampaka, Katuka, Vacha, Triphala, Padmaka, Patha, Haridra, Daruharidra, Swetasariva, Krishna sariva, Pippali, Gajapippali, Nimba, Yashimadhu, Indrayava, Vasa, Moorva, Satavari, Patola, Musta, Trayanti, Kiratatikta, Ushira,Vishala, Dhanvayas, Amruta, Ativisha, Grutha. This Yoga is told as Gunairabhydhikam in Kushta.19

The Yoga Jeevathyadi Grutha thaila is reviewed from AshtangaHrudaya.It containsJeevanthi,Manjishta, Darvi,Kamplillaka,Payas, Tuttha and are added to Grutha and Taila and cooked.20AfterwardsSarjarasaMadhuchishta are added and is in the consistency of emollients and is indicated in Ekakushta.

PREVIOUS RESEARCH WORK DONE: No research work had conducted on EkaKushta with special reference to Ichthyosis.

6.3 OBJECTIVES OF THE STUDY:

1.To evaluate the efficacy of Mahatikthaka Grutha and JeevanthyadiYamakain the management of Ekakushtha(Ichthyosis vulgaris) in children.

2.To study the quality of life in children affected with Eka Kushta (Ichthyosis Vulgaris).

7. MATERIALS AND METHOD:

7.1:SOURCE OF DATA:

The literary source of the present study will be collected from the classical texts,modern texts,published articles in reputed journals and from website.

30 patients with Ekakushta will be taken for the study from the OPD & IPD of S.D.M college of Ayurveda and other hospitals in Karnataka.

7.2 DRUG SOURCE:

The required medicine is collected from SDM Pharmacy,Hassan,Karnataka

7.3 METHOD OF COLLECTION OF DATA:

The diagnosed cases of Ekakushta (Ichthyosis Vulgaris) will be selected for the study based on the Diagnostic criteria and Inclusion criteria as mentioned. Base line data and details of disease will be collected from direct personal interaction.

DIAGNOSTIC CRITERIA:

Patients with signs and symptoms of Ekakushta and Ichthyosis present invariable with this can be taken.

1. Aswedan(hypohidrosis)21

2. Mahavashtu(area of involvement is wider) 3. Matsyashakalopamam(fishy scales)

4. Pruritis

5. Typical morphology and Characteristic distribution of scales- large brownish angulated scales present all over the body, sparingthe face and the flexural folds suchas the cubital and the popliteal fossae,axillae and groins. The scales are more prominent on extensor surfaces.

6. Keratosis pillaris over upper arm and thighs22.

7. Superficial fissuring.

8. Personal or family history and family pedigree of ichthyosis.

INCLUSION CRITERIA

The patients diagnosed based on the diagnostic criteria

The patient in between the age group of 1 year and 16 years will be included for the study.

Patients of either gender.

EXCLUSION CRITERIA:

Patients associated with any congenital anomaly.

Patients suffering from associated secondary infectious diseases and chronic

Systemic disease.

Use of certain medications for longer period

7.4 RESEARCH DESIGN:

It will be a single group clinical study with pre-test and post-test design where in 30 patients suffering from Ekakushta will be selected irrespective of gender,caste or creed. The subjective and objective parameters will be analysed statistically.

INTERVENTIONS: Sample size-30 patients

Drug- Mahatikthakaghrita with Sitha.

JeevanthyadiYamaka : external application

Dose-Mahatiktakaghrita was given orally twice daily before food for 1 month. The dose was fixed with respect to age.

Children of 1to 2 years to be given 2.5 ml

Children of 2 years to 5 years to be given 5 ml

Children of 5 years to 10 years to be given 7.5 ml

Children of 10 to 16 years to be given 10 ml

Jeevathyadi yamaka is to be given for external application half an hour before and after bath over the skin lesions

Detergent usage is restricted

DURATION OF THE TREATMENT: 1 Month.

FOLLOW UP:

During treatment-follow up on 15thdayand 30th day.

Post treatment-follow up on 15 thday and 30 th day to know the status.

METHOD OF PREPARTION OF DRUG:

Saptaccada, Parpata, Shampaka, Katuka, Vacha, Triphala, Padmaka, Patha, Haridra, Daruharidra, Swetasariva, Krishna sariva, Pippali, Gajapippali, Nimba, Yashimadhu, Indrayava, Vasa, Moorva, Satavari, Patola, Musta, Trayanti, Kiratatikta, Ushira, Vishala, Dhanvayas, Amruta, Ativisha, the kalka of all these drugs should be taken in the quantity of ¼ th part of ghee. To this, ghee 1 part,water 8 parts and the juice of Amrtaphala should be added and cooked.23 JeevanthyadiYamaka:It contains Jeevanthi, Manjishta, Darvi,Kamplillaka,Payas, Tuttha and are added to Ghrita and Taila and cooked. Afterwards Sarjarasa, Madhuchishta are added and is in the consistency of emollients.

ASSESSMENT CRITERIA:

Subjective parameter:

1. Aswedananam

2. Pruritis

Objective Parameters:

1. Mahavashtu

2. Matsyashakalopam

3. Rukshata

4. Fissuring

5. Hyper linear palms and soles24

6. Superficial fissuring

7. Scales based on primary efficacy parameters, a composite score and secondary efficacy parmeters25.

LABORATORY INVESTIGATIONS: None

STATISTICAL METHODS :Paired t test.

DURATION OF THE STUDY:2months

7.5 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION? - YES

LIST OF REFERENCES:

1. Sharma RK, Das B. CharakaSamhita, Chakrapanidatta. reprintedi. Ayurveda Dipika commentary. Varanasi: Chaukhambha Sanskrit Series; 2004. p. 320 2. Sharma RK, Das B. CharakaSamhita, Chakrapanidatta. reprintedi. Dipika commentary. Varanasi: Chaukhambha Sanskrit Series; 2004. p. 32. 3. Kerdel FA & Acosta FJ. Keratinizing Disorders.Dermatology Just the Facts. Singapore: McGraw Hill; 2003. p.9 4. Dhar Z, Disorders of Keratinization. In editor. Color Atlas and Synopsis of Pediatric Dermatology. New Delhi: Jaypee Brothers Medical Publishers(P) Ltd; 2008. p.31

5. Behl PN, Aggarwal A &Srivastava G. Congenital Disorders. In 10 th edition editor.Practice of Dermatology. New Delhi: CBS Publishers; 2005. p.362-3 6. Bajaj AK, Sharma R &Dhar S. Disorders of Keratinization. In 2 nd edition. Dermatology,Leprosy and Sexually Transmitted Infections. New Delhi: Jaypee; 2010.p.7. 7.B. Ghosh S, Ghosh K &Kundu S. In editor.Manual of Rational Skin Therapy and Dermatological Drugs.Newdelhi: Jaypee Brothers Medical Publishers ; 2010. p.268 8. CharakaSamhita, Ayurveda Dipika commentary. Varanasi: ChaukhambhaSanskrit Series; 2004. p. 329

9.TewariPV.Editor. KasyapaSamhita, reprint ed.Varanasi: ChaukhambhaVisvabharati Samsthan;2008.p.23. 10. Tewari PV. Editor.KashyapaSamhita, reprinted ed. Varansi: ChaukhambhaVisvabharatiSamsthan; 2008.p.197 11. Murthy KR, MadhavaNidana, Madhavakara reprinted ed. Chaukhambha Orientalia;1995.p.162S 12.Sharma RK, Das B. CharakaSamhita, Chakrapanidatta. Reprint tedi. Ayurveda Dipikacommentary. Varanasi: Chaukhambha Sanskrit Series; 2004. p. 325 13.Sharma P.V, SusruthaSamhitha,.Reprint edi.Dalhana Commentary. Varanasi:ChaukammbhaVisvabharathi; 2005.p.40. 14. Tewari PV. Editor.KashyapaSamhita, reprinted ed. Varanasi: ChaukhambhaVisvabharatiSamsthan; 2008.p.198. 15. Bhela, Bhelasamhita. edited by K R Shrikanthamurthy, reprint ed. ChaukambaVishvabharati, Varanasi, U.P. 2008: p. 332 16. Sehgal VN, Ichthyosis. 4th edition editor.Textbook of Clinical Dermatology.NewDelhi: Jaypee Brothers; 2004. p.173. 17. Kerdel FA & Acosta FJ. Keratinizing Disorders. Dermatology Just the Facts Singapore: McGraw Hill; 2003. p.9 18. Sehgal VN, Ichthyosis. In 4 th edition editor. Textbook of Clinical Dermatology.NewDelhi: Jaypee Brothers; 2004. p.174 19. Sharma RK, Das B. CharsakaSamhita, Chakrapanidatta. Reprintedi. Ayurveda Dipika commentary. Varanasi: Chaukhambha Sanskrit Series; 2004. p. 355-6 20.Murthy KR, AshtangaSamgraha, 2nd edition. Varanasi: Chaukhambha Orientalia;1999.p.507 21.Kerdel FA & Acosta FJ. Keratinizing Disorders. Dermatology Just the Facts Singapore: McGraw Hill; 2003. p.9 22.Hossain AS, Disorders Due to Kertinization and Collagen Defects. In 2006 editor. Hand book of Dermatology and Venereology. Delhi: AITS publishers; 1999. p.68 23. Sharma RK, Das B. CharakaSamhita, Chakrapanidatta. Reprintedi. Ayurveda Dipika commentary. Varanasi: Chaukhambha Sanskrit Series; 2004. p. 320 24. Bhushan P Genodermatoses. In 1stedition.Dermatolgy in a week. NewDelhi:Jaypee;2006. 25. Chatterjee S, Datta RN, Bhattacharya D, Bandopadhyayya D. Emollient andantipruritic effect of itch cream in dermatological disorder. Indian Journal of Pharmacology [homepage on the Internet]. 2005 [cited 2013 Mar 14]. Available from: http:// 4http://www.ijp- online.com/medlineresult.asp

9. SIGNATURE OF THE CANDIDATE :

10. REMARKS OF THE GUIDE : 11. NAMES AND DESIGNATION OF:

11.1 GUIDE :DR. SHAILAJA. U.M.D (Ayu), PhD PROFFESSOR AND HOD DEPARTMENT OF P.G STUDIES IN KAUMARABHRITYA, S.D.M.C.A.&H., HASSAN- 573201

11.2 SIGNATURE :

11.3 H.O.D : DR. SHAILAJA. U.M.D (Ayu), PhD PROFFESSOR AND H.O.D. DEPARTMENT OF P.G. STUDIES IN KAUMARABHRITYA, S.D.M.C.A.&H., HASSAN, 573201

11.4 SIGNATURE :

12. REMARKS OF CHAIRMAN AND PRINCIPAL :

12.1 PRINCIPAL :DR. PRASANNA N. RAO M.S.(Ayu)PhD

S.D.M. COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN- 573201

12.2 SIGNATURE WITH SEAL :