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effect of Ayurvedic medicines in the treatment of ChronicAllergic Conjunctivitis

Phase 2
Completed
Conditions
Health Condition 1: null- Chronic Allergic ConjunctivitisHealth Condition 2: H104- Chronic conjunctivitis
Registration Number
CTRI/2018/02/011782
Lead Sponsor
Central Council for Research in Ayurvedic Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
55
Inclusion Criteria

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 following objective and subjective

parameters i.e.-Redness,Itching,Lacrimation,

Photophobia,FB Sensation,Burning

Sensation,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

Exclusion Criteria

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 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
NameTimeMethod
â?¢Changes in VAS in subjective Symptoms e.g. <br/ ><br>Itching, Lacrimation, photophobia, FB sensation, <br/ ><br>Burning sensation and presence or absense of <br/ ><br>Lid swellingTimepoint: At baseline,14,28,42,56 and at the end of follow <br/ ><br>up after 10 weeks.
Secondary Outcome Measures
NameTimeMethod
Change in grading pattern of rednessTimepoint: At baseline,14,28,42,56 and at the end of follow <br/ ><br>up after 10 weeks.
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