Development standardization and clinical evaluation of Punarnava Arka in Dry Eye Syndrome w.s.r.t. Shushkakshipaka- Randomized Controlled Clinical Trial

SUMMARY

Dry eye syndrome (DES), a common ocular condition, arises when the tear film does not adequately support biological functions of the ocular surface. It is having considerable impact on visual function, daily activities, social and physical functioning, workplace productivity, and quality of life. 66% Of Asian population suffering from DES and they experience varying severity of symptoms. Even though Carboxy methyl cellulose 0.5% eye drop has proven to be effective in DES, it is having some adverse effects like Blurring of vision, eye irritation etc. So, in this present study Punarnava Arka Aschotana, a yoga mentioned in Arka Prakasha which is having anti-inflammatory and anti-oxidative properties, has been selected to find an effective and long-standing cure for dry eye syndrome.

RESEARCH PLAN

MATERIALS AND METHODS

DRUG

SANSKRIT NAME

BOTANICAL NAME FAMILY

PART USED

PROPERTIES

|Punarnava

Latin Name

Boerhavia diffusa

Family

Nyctaginaceae

Root

Madhura, Tikta, Kashaya

Laghu, Ruksha

Katu Vipaka

Sheeta Virya

Shleshma rakta Pittahara

PREPARATION OF PUNARNAVA ARKA

Sl.

Ingredients

Quantity

|01.

Punarnava

1 Parts

|02.

Water

35 Parts

  ANALYTICAL PARAMETERS

Punarnava

·         Physicochemical analysis

·         Microbial limit

Arka

·         Organoleptic parameters

·         pH

·         Specific gravity

·         Microbial load

·         GCMS

·         Sterility study

·         Accelerated Stability study (0,1,3,6 month)

CLINICAL STUDY

Study type                – Interventional

Study site                 – KLE Ayurveda Hospital Shahapur, Belagavi

Study design           – Randomized controlled trial

Groups                      – 2

Sample size             – 30 each

Diagnostic criteria

1.     Reduced quantity of Tear Fluid

2.     Reduced stability of Tear Fluid

Inclusion criteria

Ø  Clinical features of DES with reduced quantity and stability of Tear Fluid

Ø  Age of 18 to 40 years and of either genders

Exclusion criteria

Ø  Severe conditions like Steven Johnson’s syndrome, Chemical-Thermal-Radiation burns, idiopathic atrophy, Trachoma, Ocular pemphigoid

Ø  Corneal epitheliopathies like Neuroparalytic keratitis, post-herpatic / post-measles infection of cornea,

Ø  Conjunctival epitheliopathies like Pterygium, Pseudo-pterygium, Tumours, Retention cysts, chronic low grade bacterial / viral conjunctivitis

Ø  Lid abnormalities like Meibominitis, Blepharitits, Facial nerve palsy, Lagophthalmous,

Ø  Lacrimal gland diseases like infiltration of gland with sarcoidosis, lymphoma, leukemia and amyloidosis, congenital Alacrima

Ø  Vitamin A deficiency, effect of the drugs like atropine, antihistamine, diuretics

Ø  Specific systemic infections like Tuberculosis, Leprosy, Hypertension, RA, Diabetes mellitus, etc.

INTERVENTION

Sample size

Drug

Dose and duration

BT

AT

FU

|3****0

Punarnava Arka

1 drop of Arka 6 times a day for 30 Days

0th day

30th Day

45th day

|3****0

Carboxy methyl cellulose 0.5% Eye drop

1 drop 4 times a day for 30 days

0th day

30th Day

45th day

ASSESSMENT CRITERIA

Subjective parameters

Ø  Feeling of Dryness in Eyes

Objective parameters – BT and AT

Ø  Schirmer’s Test

Ø  Tear Break-up Time