A clinical study to see the effect of some Ayurvedic formulations in the management of Chronic Allergic Conjunctivitis
- Conditions
- Health Condition 1: null- Chronic Allergic Conjunctivitis
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 55
1.Patients of either sex with age between 18 and 60 years.
2.Patients presenting with signs and symptoms of Chronic Allergic Conjunctivitis having history of seasonal or perennial allergic conjunctivitis for at least 1 year on the basis of objective and subjective parameters i.e.-
i.Redness
ii.Itching
iii.Lacrimation
iv.Photophobia
v.FB Sensation
vi.Burning Sensation
vii.Lid Swelling
3. Patients willing to participate and give written informed consent to participate in the study for 10 weeks including 2 weeks without drug follow-up
1)Patients having associated marginal corneal ulcer, Dacryocystitis, Trachoma, Kerato-Conjunctivitis, infective conjunctivitis, allergic to dyes and seborrhic Blepharitis, dandruffs etc.
2)Patients positive for conjunctival smear and culture to exclude any infective occurrence.
3)Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit.
4)Patients having serious Renal Dysfunction, uncontrolled Pulmonary Dysfunction, (asthmatic and COPD patients) or other concurrent severe disease.
5)Patients with uncontrolled Diabetes Mellitus (Blood Sugar Fasting > 250 mg/dl)
6)Patients with poorly controlled Hypertension ( > 160/100 mmHg).
7)Pregnant / lactating females.
8)Patients on steroids, oral contraceptives, or estrogen replacement therapy.
9)Smokers/Alcoholics and/or drug abusers.
10)Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro - Endocrinal disorders, etc.).
11)H/o hypersensitivity to the trial drug or any of its ingredients.
12)Patients who have completed participation in any other clinical trial during the past six (06) months.
13)Any other condition which the Investigator thinks may jeopardize the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Changes in VAS in subjective Symptoms e.g. Itching, Lacrimation, photophobia, FB sensation, Burning sensation and presence or absense of Lid swellingTimepoint: At baseline,14,28,42,56 and at the end of follow up after 10 weeks.
- Secondary Outcome Measures
Name Time Method Change in grading pattern of rednessTimepoint: At baseline,14,28,42,56 and at the end of follow up after 10 weeks.