EFFECT OF DURVA GHRITA ASHCHYOTANA, KSHEERABALA TAILA 21 PRATIMARSHA NASYA AND SHATAVARYADI CHURNA IN THE MANAGEMENT OF SHUSHKAKSHIPAKA (DRY EYE SYNDROME)-AN OPEN LABELLED DOUBLE ARM RANDOMIZED CONTROLLED CLINICAL TRIAL.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Reduction in signs and symptoms of shushkakshipaka (dry eye syndrome)
Study Overview
Brief Summary
Dry eye syndrome is 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 also known as keratoconjunctivitis sicca (KCS) characterised by inflammation of the ocular surface and lacrimal glands. The symptoms include dryness of eyes, foreign body sensation, photophobia and redness.The present line of management of dry eye is regular use of lubricant eye drops/artificial tear which provides only symptomatic relief for short period. Shushkakshipaka is a similar disease explained in sarvakshigata roga. In the initial phase it is a vata predominant disease with pittanubandha. But if not properly managed it can lead to pittakopa causing paka of ocular tissue.Ayurveda envisage definite treatment for such clinical conditions. The general management of shushkakshipaka includes snehapana, nasya, seka, ashchyotana, tarpana etc. An attempt is made here to evaluate the efficacy of durva ghrita ashchyotana, ksheerabala taila 21Apratimarsha nasya along with shatavaryadi churna as oral medicine in the management of shushkakshipaka(dry eye syndrome). A study was conducted in ITRA, Jamnagar with shunthyadi ashchyotana, anutaila pratimarsha nasya and triphaladi yoga as oral medication in the management of shushkakshipaka(dry eye syndrome)which was found to be effective. Hence this protocol is taken as standard control in the study.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 21.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients willing for the treatment.
- •Patients having the clinical features of shushkakshipaka (Dry eye syndrome).
- •Patients of 21-70 years having mild to moderate dry eye syndrome.
Exclusion Criteria
- •The patients who are planning for ocular and/or lid surgeries within the study period Patients having uncontrolled systemic disease like diabetes, hypertension etc.
- •Severe cases of dry eye syndrome with complications like corneal ulcer, Glaucoma Uveitis, etc.
- •Allergic and inflammatory conditions of eye like Acute conjunctivitis, Vernal keratoconjunctivitis, giant papillary conjunctivitis etc.
- •Patients on steroids, oral contraceptive pills, oestrogen replacement therapy or any other medication such as antispasmodic drugs like Atropine that may adversely affect the outcome of the study H/o hypersensitivity to the trial drug or any of its ingredients.
Outcomes
Primary Outcomes
Reduction in signs and symptoms of shushkakshipaka (dry eye syndrome)
Time Frame: 60 days
•Comparative efficacy of group A with Group B
Time Frame: 60 days
Secondary Outcomes
- 1.Change in ocular health in terms of visual acuity.(2.Assessment of the trial drug for its pharmacognostical and phytochemical properties.)