A randomized controlled clinical trial to study the effect of triphala churna with madhu in timir with special reference to simple myopia
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Reduction in signs and symptoms of timir after taking Triphala churna with madhu orally
Study Overview
Brief Summary
PURPOSE OF STUDY- Due to significance of myopia as a global health concern, In VISION-2020 which is the foremost large scale program run by WHO has one of its objective to control and treat uncorrected refractive errors.Myopia even of mild degree shuts the door of military, navy or pilot schools, for thousands of young people who dream of such professions.Myopia progression is irreversible and there is no cure. In modern science the treatment for myopia is use of eye glasses, contact lens and refractive surgeries like Laser assisted in-situ keratomileusis (LASIK), Laser assisted sub epithelial keratectomy (LASEK).Methods of correction of Myopia is not without complication including corneal infection due to contact lens wearing and corneal scaring and persistent corneal haze from refractive surgery.Refractive surgeries for treatment of myopia are both expensive and unsuitable for eyes of certain patients due to complication.Hence the ayurvedic science can be explored to serve a better alternative to manage this condition.In Ayurveda the use of local and systemic drugs is recommended in management of Timir.So there is a possibility to evolve a new remedy from Indian Medicinal Pharmacopeia particularly for Timira with special reference to Simple Myopia.
AIM- To study the effect of Triphala churna with madhu in Timira with special reference to Simple Myopia.
OBJECTIVES- 1.To study the improvement in symptoms of Timir with special reference to Simple Myopia.2.To study the changes in refractive powers after using Triphala churna with madhu for 30 days in Timir with special reference to Simple Myopia on the basis of subjective and objective criteria.
HYPOTHESIS- NULL HYPOTHESIS: Triphala churna is not effective in Timir with special reference to Simple Myopia.
ALTERNATIVE HYPOTHESIS: Triphala churna is effective in Timir with special reference to Simple Myopia.
PROCEDURE- Approval from Institutional Ethical Committee (IEC) has been taken before commencement of trial.All patients diagnosed with Simple Myopia from assessment will be approached with the study proposal.Total 90 patients with Simple Myopia will be included after proper assessment and screening according to Inclusion and Exclusion Criteria.Those fulfilling the Inclusion criteria will be explained in details about the study in their most communicable language.Written informed consent in their preferred language will be obtained from the patients agreeing to participate.The patients will be randomly divided into two groups.In Group A Trial drug ie Triphala churna will be given and in Group B Control drug ie Amlakyadi churna will be given.Trial and Control drugs will be purchased from GMP Certified Pharmacy.Both drugs will be administrated orally for 30 days.Observations will be done on day 0,day 14,day 30 and day 45.Result of the study will be drawn on the basis of criteria of assessment and statistical analysis.Discussion will be done on the basis of observations and results obtained during treatment.Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn on the basis of statistical analysis and will be unbiased.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 30.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of age group between 18-30 years with the clinical symptoms of prathama patalgata timira (simple myopia)
- •Patients having -0.25 D to -3.00 D Spherical power with normal Fundoscopic findings.
Exclusion Criteria
- •Congenital myopia, Pathological myopia, Acquired or Secondary type of myopia that occurs due to some factors or diseases i.e. post traumatic, drug induced etc.
- •Patients who have myopia assosiated with other refractive errors such as Astigmatism.
- •Patients who are known case of hypertension,diabetes mellitus.
- •Patients who have active infectious diseases ie viral, fungal, bacterial conjunctivitis, trachoma, blephritis, Patients below 18 years and above 30 years Patient who have refractive index more than -3 D spherical.
Outcomes
Primary Outcomes
Reduction in signs and symptoms of timir after taking Triphala churna with madhu orally
Time Frame: 30 days
Secondary Outcomes
- where the trial group stands in comparison with control group(18 months)
Investigators
Dr Ashwini Raosaheb Borude
SMBT Ayurved College and Hospital