RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. NAME OF THE CANDIDATE : DR. SHWETA CHAUHAN

AND ADDRESS D/O DR. PRITAM SINGH CHAUHAN

TEH: HIRANAGAR, DIST: SAMBA

TOWN: GHAGWAL,PIN.184141

STATE: JAMMU & KASHMIR

2. NAME OF THE INSTITUTION : D.G.M. AYURVEDIC MEDICAL

COLLEGE AND HOSPITAL,

POST GRADUATE STUDIES

RESEARCH CENTRE,GADAG,582103

3. COURSE OF STUDY : AYURVEDA VACHASPATI (M.D)

SUBJECT RASASHASTRA

4. DATE OF ADMISSION : OCTOBER- 2011

5. TITLE OF TOPIC : “PREPARATION, PHYSICO

CHEMICAL STUDY OF SWETARI YOGA AND SWITRAHARALEPA, AND THE CLINICAL STUDY ON SWITRA.”

6. BRIEF REVIEW OF INTENDED WORK

6.1 Need for the study:

Skin is a largest organ of our body. The beauty and attraction of individual depends upon skin’s health including physical and psychological health. The skin has long been recognized as the ‘organ of expression’ and serves as the boundary between ourselves and the outside world, a ‘first point of contact’ when strangers meet us Dermatological disorders have an immediate impact on tactile communication and bodily interaction. In particular fear, anxiety as well as sexual pleasure and excitement can be indicated in skin(1). From the stone ages also stressed the importance of cosmetics and measures for cosmetology been highlighted is witnessed.

Switra, one of the common skin disorders which is correlated with Vitiligo to certain extent in contemporary system of medicine. Normal skin colour is dependent on hemoglobin (in both the oxygenated and reduced state), carotenoids and melanin pigment(2). Vitiligo is a common disorder of unknown etiology even today(3). It is an acquired condition in which circumscribed de-pigmented patches develops. World wide prevalence of Vitiligo is observed as 1% of the world population(4).

Highest incident has been recorded in India and Mexico. Based on dermatologic out patient record, it is estimated between 3-4% in India, although an incident as high as 8.8% has also been reported(5), irrespective of the races especially to dark skinned people.

In modern the main stay of the treatment for Vitiligo, PUVA (Psoralin Ultra Violet Airradiation) can cost close to 6000 $(Rs. 2,95,000) or more per patient(ref.Vitiligo website contents c. 1998 A.D.A.M. software,inc.)Though surgical treatment for Vitiligo has been mentioned. It has many limitations:

Epidermal grafting

Thin thiersh grafting

Mini grafting

Vitiligo is a disease of cosmatic deformity and social problem (ref.N.V.K.)

. The effective treatment are yet to be found out, as the response rate is very much less with the present remedies available. Modern medicine having so many complications & having more side effects; toxicity is more. It is costlier than other medicine but in our Ayurvedic classics, Acharayas have mentioned so many formulations in one disorder it is not so that all medicine should be given according to the condition of the patient i.e. by looking at dosha bala & rogi roga bala, medicines has to be selected and given either as single formulation or in the combined form.

Swetrari yoga and Switraharalepa are effective herbomineral components which are explained in Rasashastra texts, especially indicated in Switra Roga by Rasaratna samuchaya and Bhaishjya ratnavali.

Swetariyoga and Switraharalepa selected, have internal and external applications respectively as thus contents of the yoga are quite economics & indicated in Switra Roga by Acharyas.

Due to increased prevalence of Switra i.e.8.8% and less effective with more complications of treatment of modern medicines, it is the need of hour to find out good and safe remedy for Switra roga. In ayurveda Swetariyoga and Switraharalepa have been mentioned for Switra roga, there acharyas have mentioned that these are more potent and cost effective Hence considering above all consequences present work is being undertaken.

6.2 Review of Literature

The disease Switra as a skin disease is found in vedic literature under terms kilas, sweta kusta and palitha. In Rigveda (6000BC) the term kilasa is mentioned as a name of spotted deer. In Atharvaveda four chief drugs have been mentioned for the treatment of shwetha kusta such as Rama, Krishna, Asikini and Rajani.

We will get detail explanation of switra as a separate skin disorder; after kushta roga in many classical texts viz. Charaka samhita(6),(7),(8),(9), Susruta Samhita(10), Astanga Hridaya(11),(12), Bhava prakasha(13), Madava nidana(14), Shargandhara samhita(15), Yoga ratnakara(16), Rasa ratna samuchaya(17), Vangasena(18), Kashyapa(19) included Switra under nine types of asadya kushta. Bhaishjaya Ratnavali(20).

According to Charaka, Switra is one among three types of kilasa and classified it on prevalence with dhathu involved and affected colour(6). Nidana told for it are asathya, krithagna bhava, ninda of devathas, guru apamana, papa kriya, poorvajanma kritha karma(7) etc. he highlighted the sadhya lakshana as not with thick skin pandu varna, spots are curable(7). He mentioned Switra under Rakta pradoshaja vikara(21).

Although there are many other preparations mentioned in Rasashastra classics, the method of preparation of Khalvi rasayana has its own significance because of specific pharmaceutical process as mardana supplied in this procedure stabilizer firm bonding between the constituents forming a coordinating complex with a wide range of therapeutic efficacy.

Swetariyoga: It contains shudh Gandhaka, Bhringaraj churna, Katu tumbi beeja churna, and Bhallataka & krishna Tilatail, Nimba churna. Make a churna of all these drugs and give 21 Bhavana with Bhrungaraj swarasa then kept in shadow and dry. It is described by Rasaratna samuchaya in (20th Chapter/167 shloka).

Switraharalepa: it is one of rasoushadhi contains shudh kasisa, triphala, raktachitraka, hartala, gandaka make a churna of all these drugs which are triturated with water.(Explained in B.R. 54th chapter-52 shloka)

Previous research (M.D. dissertation) work done on switra:

  1. Dr. Sheela Ratna M.V,switra roga & its management Mysore, Mysore University 1979.
  2. Dr. Patil A.K, Survey of Switra in Jamnagar & vicinity in reference to its nidan & chikitsa, Jamnagar, Gujarat Ayurvedic University 1984.
  3. Dr. Upadhyaya R.K, Therapeutic assessment of some ayurvedic drugs in treatment of vitiligo,Varanasi, Banaras Hindu University 1985.
  4. Dr.Shankaran K., Management of Switri with special reference to Bakuchi, Trivandrum ,1986.
  5. Dr. Lahiri P.K, Clinical studies and Management of Switra Kustha with Ayurvedic drugs, Calcutta ,1987.
  6. Dr. Pritivi Raj , Concept of Switra and its Management in Ayurveda, Varanasi,1988.
  1. Dr.kavita S Mittalakod, Guided by Dr.Girish N.Dnanapagowdar,Dept.of Rasshastra, Preparation and Physico Chemical Analysis of Switrari Rasa and Lepa, their clinical efficacy on Switra, Gadag 2009

.

  1. Dr Bhagyesha K, Guided by Dr.S.Suresh babu, Dept of Kayachikitsa, Evaluation of effect of Ankolakadi yoga in Switra W.S.R Vitiligo, Gadag,2011.

6.3. Aims and Objectives of the study:

  1. Preparation of Swetariyoga and Switraharalepa as per the Classical reference
  2. Physico chemical study of Swetari yoga and Switrahara lepa.
  3. Clinical study:- validating of pigmentation effect in Switra with Swetari yoga and Switrahara lepa by double blind method.

7) Materials and Methods :-

7.1) Source of data:

  1. Litrary: Literary aspect will be collected from classical Ayurvedic and modern text and internet also
  2. Drug: The raw material will be collected from the market and our college garden.
  3. Preparation: Preparation of Swetariyoga and Switrahara lepa will be done according to Rasa Ratnasamuchaya and Bhaishjya Ratnavali in Pharmacy department, Post Graduate & Research Center, D.G.M. Ayurvedic Medical College, Gadag
Sl.No. / Swetari yoga / Quantity / Switrahara lepa / Quantity
1. / Shudh gandhak(Sulphur) / 1 Part / Shudh kasisa(Ferrous sulphate) / 1 Part
2. / Bhringraj churna(Eclipta alba) / 1 Part / Rakta chitraka(Plumbago zeylanica) / 1 Part
3. / Krishna tila taila(Sesamum indicum) / 1 Part / Triphala churna / 1 Part
4. / Katutumbibeeja churna(Lagenaria siceraria) / 1 part / Haratala (Orpiment) / 1 Part
5. / Bhallataka (Semicarpus anacardium) / 1 part / Shudh gandhak(Sulphur) / 1 Part
6. / Nimba churna (Azadi rachta indica) / 1 part / Jala / Q.S
7. / BhringarajSwarasa (Eclipta alba) (bhavana) / Q.S.

D. Analysis: Physio chemical analysis as per API will be done in recognized laboratory.

E.  Patients: Sample of 30 patients divided in three groups with confirm diagnosis will be taken from OPD and IPD of D.G.M Ayurvedic Medical College and Hospital Gadag.

7.2) Method of collection of data: a) Study Design:

1) Pharmaceutical Study: All the constituents of Swetariyoga and Switrahara lepa will be collected from market area and our college’s D.G garden. Good manufacturing practice will be followed for the preparation of Swetariyoga and Switraharalepa will be prepared as per Classical reference.

2) Analytical Study: Physico-chemical analysis of Swetariyoga and Switraharalepa will be done and recorded from well equipped recognized laboratory.

Parameter such as fineness of particles, ash value, Acid insoluble ash, loss on drying, PH value , XRD will be done.

3) Clinical Study:

a) Simple random single blind study.

1)  Group A - Internal à Swetariyoga

2)  Group B - External à Switraharalepa

3)  Group C - Internal+External à Swetariyoga + Switraharalepa

b) Sample sizes:

1. Total no.of patients 30.

2. A minimum of 10 patients will be taken for the each group.

c) Inclusion criteria:

1.  Patients other than exclusive criteria are included

2.  Vitiligo (L80 of ICD 10)

3.  Patient with classical symptoms of Switra as explained in Ayurvedic Classics. The symptoms are swetha , mandala( whitish patches), ruksha(dryness), parusha , daha, kandu, guruthva(heaviness of body).

4.  And Diagnosed case of vitiligo acc. to the contemporary diagnostic system are included.

d) Exclusion criteria:

1.  Patient below 15 years and above 60 years of age, irrespective of sex.

2.  Pregnant women and lactating women.

3. Burn’t areas.

4. Lesion over lip, genital areas would be excluded.

5. Vogt-koyanagi syndrome.

6. Autoimmune disease.

7. Hypothyroidism

8. Addissions disease.

9. Diabetes

10. Alopecia areata

11. Pernicious anaemia

12. Halonaevus

13. Lichen sclerosus

14. Pityriasis rosea

15. Seborrhoeic dermatitis

16. Morphoea

e) Diagnostic criteria:

As per the clinical features of Switra mentioned in classics, cases are diagnosed.

f) Posology:

Abyanthara: 24gms/day given in divided doses with Sharkara as anupana.

Bahya: Sufficient quantity of the lepa is used then exposed to photo light once in a day.

g) Study duration:

90 days for each group

h) Follow up:

30 days

i) Assessment of Result:

The subjective and objective parameters of base line data to post medication will be compared for assessment of the result.

j) Subjective parameters:

Sympotms of Switra as well as Vitiligo explained in ayurvedic and modern texts respectively will be the subjective parameters such as:

  1. Twak shwethata – whitish discolouration with complete dipigmented skin

Grade 0 – normal – normal skin colour

Grade 1 – mild – less pigmentation and more pigmentation over a lesion

Grade 2 - moderate – depigmentation more than pigmentation or equal over lesion

Grade 3 – severe – no pigmentation totally white colour over lesion

  1. Arun varnata :

Grade 0 – normal – normal skin colour

Grade 1 – mild – less aruna varnata and more pigmentation

Grade 2 - moderate – more aruna varnata than normal colour or equal over lesion

Grade 3 – severe – totally aruna varna over the lesion

  1. Tamra varnata :

Grade 0 – normal – normal skin colour

Grade 1 – mild – less tamra varna and more pigmentation

Grade 2 - moderate –more tamra than normal colour or equal over lesion

Grade 3 – severe – totally tamra varnata over the lesion

  1. Twak rukshta :

Grade 0 – normal – no dryness

Grade 1 – mild – dryness on exposure to cold and sunlight and other allergents

Grade 2 - moderate – dryness during exposure to cold environnment

Grade 3 – severe – always dryness

  1. Daha :

Grade 0 – normal – no burning sensation

Grade 1 – mild – burning sensation on expose to mid noon sunlight

Grade 2 - moderate – burning sensation morning sunlight exposure and other iritants

Grade 3 – severe – always burning sensation

  1. Roma vivarnata :

Grade 0 – normal – normal hair colour

Grade 1 – mild – less than 25% of hair over the lesion has vivarnata

Grade 2 - moderate –25% - 75% of hair over the lesion has vivranata

Grade 3 – severe – more than 75% of hair over the lesion has vivarnata

  1. Kandu :

Grade 0 – normal – no itching

Grade 1 – mild – itching on exposure to cold and sunlight and other allergants

Grade 2 - moderate – itching on exposure to mild cold environment

Grade 3 – severe – always itching

8. Ghana:

Grade 0 – normal – normal thickness of skin

Grade 1 – mild – not complaint by patient but felt by examiner

Grade 2 - moderate – complaint by patient

Grade 3 – severe – thickness by appearance

k) Objective parameters :

1)  Colour

2)  Margin

3)  Number

4)  VASI

l) Investigation:

  1. Hemoglobin%
  2. Differential count
  3. Total count
  4. Random blood sugar
  5. Erythrocyte sedimentation rate.

m) Statistical analysis: The subjective and objective parameters of base line data to post medication will be compared for assessment of the results. Results will be analyzed statistically using anova test and intercomparison of results among the groups will be done by using paired ‘t’ test.

7.3) Does the study require any investigation/intervention to be conducted on patients?

Yes. The study will be conducted on switra rogi only and will be administered Swetariyoga and Switrahara lepa after taking their concent.

7.4) Ethical clearance:

Obtained and enclosed

8. LIST OF REFERENCES

1.  Carl walker and Linda papa papo ulas ed. Psycho dermatology (psychological inence of skin disorder) Ch. 1, 1st ed-2005, Cambridge publication, pp. 1,www.cambridge.org.

2.  Siddharth nisha ed. API Text book of Medicine, dermatology, ed-8th 1999, Association Physician of India Mumbai, pp. 1411, 1412, 1463.

3.  Robbins, Cotran, Kumar ed. Pathologic basis of disease, 27th Chapter, W.B. Saunders company,. pp. 1274.

4.  John A. A. Hunter ed, Davidson’s principles and practice of medicine, 19th ed, 2002, 21st chapter, Churchill Livingstone, pp 1086, 1087.

5.  R.G. Valia ed. Text book and atlas of dermatology 22nd chapter 1st ed, 1994, Bhalani publishing house Bombay, pp. 518, 519.

6.  Yadavaji Trikamji Acharya ed, Charaka Samhita Chikitsa 8/173-174 1st ed, reprint 2008, Chaukhambha subharathi prakashan, Varanasi, pp 458.