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«Standardization and clinical evaluation of Keshanjana -an Ayurvedic formulation in Shushkakshipaka (Dry Eye Syndrome) Principal Investigator: Prof. ...»

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FINAL SUBMISSION REPORT OF EXTRA MURAL RESEARCH PROJECT

TITLED:

Standardization and clinical evaluation of

Keshanjana -an Ayurvedic formulation in

Shushkakshipaka

(Dry Eye Syndrome)

Principal Investigator:

Prof. (Dr.) K. S. Dhiman

Professor & Head

Institute:

Department of Shalakya Tantra

Institute for Post Graduate Teaching and Research in

Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat-361008

Supported by:

Central Council for Research in Ayurvedic Sciences Department of AYUSH, Ministry of Health & Family Welfare, Government of India Index Sr. No. Content Page No.

1 Acknowledgement 2 Introduction 3 Aims and objectives 4 Review of literature 5 a. Drug review and SOP b. Standardization and chemical analysis c. Safety and toxicity study 6 Material and Methods 7 Results and Discussion 8 Summary & Conclusion 9 Annexure a. Informed consent form b. Case record form c. Ethics committee approval letter - Animal experiment d. Ethics committee approval letter – Human trial e. Bio-data of PI f. Research articles published by PI on present research project in peer reviewed journals.

Ayurveda, the science of healthful living is the most rational and scientific among the ancient systems, which has struck deep and permanent roots in the minds of people of this country about its capacity to provide effective cure for all types of diseases. Shalakya tantra, one among the 8 branches of Ayurveda, deals with the precious sense organs, diseases affecting them and their management.

In the systematic and detailed description of the eye diseases; Preventive ophthalmology is given equal emphasis to the curative (medical & surgical) aspect of the eye diseases.

Visual disability is a crucial one as it affects the overall development of an individual and a blind person becomes a national liability effecting the productivity of two individuals. Keeping the same after effect of lost vision

Acharya Vagbhatta quoted that:

CHAKSHRAKSHYAAM……………………………………… Life style changes, food habits environmental pollution, industrial and occupational hazards as well as the increased / injudicious use of systemic & topical medicines made the prevalence of many ophthalmic diseases very common. Shushkakshipaka (Dry eye syndrome) is one such ocular disease effecting all parts of the eye. Description as per the Sushruta samhita points towards the early phase of disease (dryness) whereas the Vagbhatta’s view reflects the advanced phase of the disease with preponderance of paka (inflammation).

Dry eye syndrome is a similar entity in the modern ophthalmology which is recognised as clinical disorder in 1920 and described clinically in 1930’s but the greatest amount of information both from an epidemiology and pathogenetic perspective has occurred during the last 2 decades, which indicate that the awareness and incidence of this disease is increasing in recent times1. Advances in the diagnostic technology have added into the prevalence rate as well.

Prevalence of dry eye is estimated to be 14-33% worldwide. i.e. 1 out of every 3 to 7 patients could have this condition2. A recent survey conducted in year 2002, based upon a well characterized population of adult men and women in USA identified a prevalence of 6.7% in women over the age of 50 and 2.3% in men over the age of 55. These rates extrapolate to potentially 9.1 million dry eye patients in USA alone1. Even though no authentic prevalence survey has been carried out in India, it is estimated that 45% of patients older than 40 years may have this problem i.e. one out of every 5 above 30 yrs attending OP could have this condition2.

There are many reasons which made increase prevalence of this disease.

The main factors include increased longevity of the people, prolonged use of certain medicines like anti-hypertensive and anti-depressants, increased use of computers and contact lens wear may contribute to the increased incidence.

Refractive surgery mainly the LASIK in young population and cataract surgeries ion old population may lead to this problem and better understanding and diagnosis may be a factor which ultimately leads to the increased incidence of dry eye2.

It is anticipated that burden of dry eye is highly significant similar to angina or disabling hip fractures in old age. Approximately 25% of patients visit to ophthalmologists are due to problems related to dry eyes. Many patients are presenting with night driving problems related to dry eyes. Many patients are presenting with night driving problems, reading problems, problems with computer and problems during watching television3. If this condition is not properly diagnosed and treated in time, it may lead to various complications like keratitis, iridocyclitis, glaucoma, endophthalmitis etc.

Regarding the treatment options, tear substitutes and tear stimulants are the main stay of the medical management. But these tear lubricants are failed to reproduce the tears because the natural tears are the complex mixture of lipids, mucin and water4. These drugs can give lubrication to the ocular surface but will not correct the underlying tissue damage & pathophysiology. The main culprit is the preservatives containing in these drops mainly benzalkonium chloride which induce corneal toxicity & desquamation, many of the patients developed allergy to this chemical and ultimately it worsens the dry eye problems i.e. patients cannot tolerate these preservatives containing eye drops for long term basis5.





New concept of preservative free eye drops came into existence to overcome these problems, but unfortunately these are very difficult to manufacture, frequent contamination on storage and microbial keratitis in many patients are reported due to use of this drops6. The main problem is the expense of these medicines and one should remember that these medicines are prescribed as lifelong therapy and many of the patients are not in a position to afford these drops due to high cost of these drugs or compliance also remains the question.

Ayurveda system of medicine considers this problem a systemic & medically manageable/curable one; so the systemic treatment modalities like Snehapaan orally, Nasya karma, Basti chikitsa and Rasayana orally as well as topical ocular therapeutic procedures (kriyakalpa) like Seka/Parisheka (closed eye irrigation), Ashchyotana (eye drops), Tarpana, Snehana Putpaka and Snehana Anjana (lubricating collyrium) are advocated in the literature.

A pilot clinical study as a MS (Ay) Netra Roga thesis titled “A clinical study on the effect of keshanjana and parisheka in the management of Shushkashipaka w.s.r. to dry eye by Vardhana Prabhakar, et. al. was guided by principle investigator where in the Ayurvedic treatment was compared with Tear substitutes in 32 patients. Ayurvedic line of treatment gave equally good relief in subjective and objective parameters as well as it was cost effective too. With this back ground, this Extra Mural Research Project titled “Standardization and clinical evaluation of Keshanjana – an Ayurvedic formulation in Shushkakshipaka (Dry Eye Syndrome)” was granted by Central Council of Research in Ayurvedic Sciences (CCRAS), Department of AYUSH, MOHFW, Govt.

of India, New Delhi having following aims and objectives:

Aims:

1. Standardization of Keshanjana including preparation analysis, toxicological (ocular surface) study.

2. To evaluate the effect of Keshanjana in patients suffering from Shushkakshipaka (Dry eye syndrome).

Objectives:

1. Drug standardization: Keshanjana (A. H. Ut. 16/30-31) composed of Masee prepared from scalp hairs and Go ghrita.

To prepare KMM i.e. Kesha masee from male scalp hairs and KMF i.e.

Kesha masee from female scalp hairs separately and assess for differences in their properties.

To analyse or to procure the Go ghrita used in preparation of Keshanjana from National Dairy Research Institute, Karnal, Haryana for its

standardization.Drug analysis:

a. To analyse Keshamasee and Keshanjana for its physical and chemical properties.

b. To analyse Keshamasee and Keshanjana for the presence of heavy metals and toxic materials e.g. mercury, arsenic, lead etc.

2. Animal experimentation:

a. To evaluate the physical, pharmacological and toxic affects of the drug on suitable aexperrimental animals.

b. To assess the changes in tear film status, conjunctival cytology findings and tear film chemistry in experimental animals.(This part of the experimental study could not be carried for want of facilities and suitable experimental model).

3. Clinical study: To evaluate the effects of Kshanjana, Kesha masee in inert ointment base, Go ghrita, and tear substitute in patients suffering from Shushkakshipaka (Dry eye) on subjective and objective parameters.

The project has now been completed and is being presented in following

sections:

1. Review of the Literature: In this section Ayurvedic and modern concept on the disease Shushkskshipaka and Dry eye are given in required details.

2. Drug Review and Standarad Operational Procedures(SOP) of the pharmaceutical phase of Keshmasee, Keshanjana ans Keshamasee ointment are presented,

3. Physico-analytical study of the contents and formulation wherein physico-chemical, microbial, particle size, inductive couple plasma(ICP) spectroscopy study for Cd, Pb, Hg, As, Zn and HPTLC.

4. Ocular surface toxicological study of the Keshanjan and Keshmasee ointment on rabbits follow OCED 405 Guidelines.

5. Clinical study and Discussion: Clinical study was conducted in patients of

Dry Eye Syndrome in four groups:

i. Group I: Treated with CMC/Tear substitute ii. Group II: Treated with Plain Ghrita iii. Group III: Treated with Keshmasee Ointment iv. Group IV: Treated with Keshanjana The observations and results are duly discussed to the best of ability.

Summary and Conclusion: In the last section whole work is summed up and concrete outcome is presented as conclusions.

References:

1. Jain MR. Medical director, M.R. institute and Jain Eye Hospital, Jaipur; Dry Eye: Emerging ophthalmic problem: Friday 19th June 2009.

2. Sahai A, Malik P. Dry eye: prevalence and attributable risk factors in a hospital based population; Indian Journal Ophthalmology 2005;53:87-91.

3. Management and Therapy Subcommittee..Management and therapy of dry eye disease: report of the Management and Therapy Subcommittee of

the International dry eye Workshop (2007).Ocul.Surf.2007;5(2) : 163Calonge M. The treatment of dry eye Surv ophthalmol. 2001; 45(suppl 2):

S 227-S 239.

5. Farris Rl. Staged therapy for the dry eye.CLAOJ 1991; 17:207-215.

6. Whitcher JP. The treatment of dry eyes. Br J Ophthalmol; 2004; 88:603Review of Literature

Concept of Lacrimal secretions in Ayurveda:

This concept has been elucidated in a review article published by Principal Investigator (vide Annexure).

–  –  –

Definition:

Old definition: National Eye Institute/Industry Workshops (NEI) 1995 defined

the dry eye as:

“Dry eye is a disorder of the tear film due to tear deficiency or excessive tear evaporation which causes damage to the interpalpebral ocular surface and is associated with symptoms of ocular discomfort.”17 This definition encompasses all of the clinical entities of dry eyes that are associated with systemic disease, as well as idiopathic dry eye disease. It also should be understood that features of dry eye can exist without demonstrable damage to the ocular surface, and that damage may occur in the absence of symptoms.

New definition: Report of the International Dry Eye Workshop (DEWS) 2007 defined dry eye as:

“A multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.”18

Epidemiology:

Epidemiological information on dry eye syndrome has been limited by lack of uniformity in its definition and the inability of any single diagnostic test or set of diagnostic tests to confirm or rule out the condition definitively. There is no doubt, though, that it is a common condition that causes varying degrees of discomfort to disability19. The most commonly cited estimate of prevalence in the United States is derived from a population-based study of 2,482 elderly people in Maryland. About 1 in 7 subjects having age 65 to 84 reported symptoms of dry eye often or all of the time. Extrapolated to the general population, Schein (1997) estimated that 4.3 million Americans in this age cohort suffer from ocular irritation and that 1 million have diagnosable disease20.

Moss (2000) reported similar overall prevalence (14.4 percent) in a larger cohort (3,722 subjects between ages 48 and 91)21. While Schein found no correlation of disease with age or sex, other researchers have made such associations; Moss noted that after age 59, prevalence more than doubled. A separate Australian study of 926 subjects age 40 and older found generally higher prevalence of dry eye in women. Epidemiological studies of dry eye syndrome in the United States and other countries suggest wide differences in prevalence. As such, definitions of dry eye syndrome have differed from study to study, making results incomparable. This is complicated by the lack of a standardized clinical testing protocol to diagnose the condition. Researchers have noted a strong connection between dry eye and both advancing age and sex.

Women experienced a sharp increase in prevalence earlier than man – around age 45, or roughly the onset of menopause19.

Nidaana (Etiology) of Sushkakshipaka:



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