A Randomized Controlled Trial of Nimba-Lodhra Arka(eye drop)Aschyotana in Vataja Abhishyanda with special reference to Allergic conjunctivitis.

After clearance of institutional ethics of Government Ayurveda College Nagpur screening of population will be done from patient in OPD and IPD of our institue.

In clinical study 40 each patients in each group of  Allergic Conjunctivitis will be included.

If patients fulfil the criteria of inclusion, subject would also given freedom to ask their questions all questions would answer.

If he/she agrees for participation in study and found fit to include the patient will include in study.

The treatment will be given to patient as follows :

Group A:

Olapetadine Hydrochloride 0.1%

Dose : 1 drop twice a day

Route: Topical

Duration : 7 days

Group B :

Nimba- Lodhra Arka Asychotana

Dose : 4 drops twice a day

Route: Topical

Duration : 7 days

Study design : Open label Randomized  Controlled Trial.

•Type of RCT : Equivalent clinical trial.

•Type of Recruitment : Parallel group.

•Study setting:  Patients in OPD and IPD of  Shalakyatantra department of our institute.

•Study duration: 18 Months after approval of synopsis.

•Study Population: Patients showing  signs and symptoms of Allergic Conjunctivitis from OPD and IPD of Shalakyatantra department of our institute.

•Randomization -

A Simple  Randomization with computerized generated random samples.

•Sampling method -

Simple random sampling.

•Study Population: Patients showing  signs and symptoms of Allergic Conjunctivitis from OPD and IPD of Shalakyatantra department of our institute.

•Randomization -

A Simple  Randomization with computerized generated random samples.

•Sampling method -

Simple random sampling.

•Sample size calculation

It is estimated based on efficacy of  Olopetadine Hydrochloride eye drop in the management of  Vataja  Abhishyanda with special reference to Allergic Conjunctivitis reported in published article.

(Reference :Eiichi Uchio ,Treatment of allergic conjunctivitis with olopatadine hydrochloride eyedro,Clin.Opthalmol. 2008 sep;2(3):525-531) with following assumptions.

Percentage of effectiveness Nimba -Lodhra Arka Aschyotana = 54.5%

Percentage Effectiveness of Olopetadine Hydrochloride 0.2% eye drop = 55%.

Inclusion criteria

1.Patient suffering from Vataja Abhishyanda with special reference to Allergic Conjunctivitis.

2.Patients of age  between 18 years to 60 years will be selected   irrespective of their gender, caste, religion, socioeconomic or educational status.

3. Patients with anatomically normal ocular structures will be selected.

4.Patients who are willing to participate in study and ready to give written consent.

 Exclusion criteria

1.Patients with additional infectious or systemic illnesses.

2.Patients suffering from other extra ocular diseases like ptosis, eyelid tumor that blocks the pupil.

3. Patients experiencing disorders of the posterior segment such as sjogren’s syndrome, diabetic retinopathy, hypertensive retinopathy, optic atrophy, macular hole, retinal detachment, glaucoma, and retinal pigmentosa/retinitis.

4.Other traumatic and inflammatory conditions of eye.

Parameter for assessment of study outcomes

The result will be categorized as, -

•Complete relief -- 75% and above.

•Moderate relief -- 50% to 74% improvement

•Mild relief -- 25% to 49% improvement

No relief -- Below 24% improvement.