Efficacy of Ayurvedic Management on Timira with special reference to Simple Myopia

Phase 2/3

Not yet recruiting

Conditions: Myopia. Ayurveda Condition: TIMIRAH,

Registration Number: CTRI/2023/05/052565

Lead Sponsor: All India Institute of Ayurveda

Brief Summary: The rising prevalence of myopia is a major challenge worldwide, giving rise to an epidemic in certain regions. It is the most common refractive error and an important cause of ocular morbidity especially affecting school-going children and young adults. One of the prime fields of interest in *Urdhwajatrugata Roga* is *Netra Vigyana* & as a result, a detailed history, anatomical, physiological, pathological aspects & management related to eyes are described in the *Samhitas.* The disorders related to partial or complete loss of vision are defined under *Drishtigata Roga.* Among these, initial mild visual disturbances occur in *Timira*which when not treated properly at appropriate time can result into complete loss of vision seen in *Linganasha**.* *Timira*,on the basis of symptoms can be correlated with refractive error, mainly myopia. Myopia or short-sightedness usually affects children & adolescents progressing up to age 16 or more. Simple myopia refers to the refractive error of -6 dioptre or less.

In Ayurveda, many modalities are mentioned which may provide relief in this condition, hold the progression and in some cases preventing it altogether. Therefore, an attempt will be made through this study. A study to evaluate comparative effect of *Shatavaryadi Churna* orally and *Shankhadyanajana* on *Timira* (Simple myopia) has been carried out previously by Dr. D. Naveen at Dr. N.T.R. University of Health Sciences, Vijaywada, Andhra Pradesh. This study gave 60% relief in the primary symptom i.e., *Avyaktadarshana* & 53.33% patients gained visual efficacy of 100% after the treatment in group getting intervened with both oral drug and *Anjana*. The present study aims to establish greater effect than the previous study. *Kaptakaphaladi Anjana* *& Dashanga Haritaki Modaka*orally has been selected for this study to evaluate their efficacy compared to the drugs used in previous study i.e., *Shankhadyanjana*& *Shatavaryadi Churna*orally in reducing the symptoms of *Timira* (simple myopia) and also check the progression of *Timira* (simple myopia).

**RESEARCH QUESTION**

What is the efficacy of local application of *Katakaphaladi Varti Anjana* (approx. 60mg two times a day for 45 days) along with oral administration of *Dashanga Haritaki* *Modaka* (6 g two times a day for 45 days) as compared to *Shankhadyanjana* (60 mg two times a day for 45 days) along with *Shatavaryadi Churna* (6 g two times a day with *Madhu* & *Ghrita* for 45 days) orally in the management of *Timira*- simple myopia?

**NULL HYPOTHESIS (H0)**

Local application of *Katakaphaladi Varti Anjana* along with oral administration of *Dashanga Haritaki Modaka* does not give better results than the local application of *Shankhadyanjana* along with oral administration of *Shatavaryadi Churna* in the management of *Timira*- simple myopia.

**ALTERNATE HYPOTHESIS (H1)**

Local application of *Katakaphaladi Varti Anjana* along with oral administration of *Dashanga Haritaki Modaka* is more effective than local application of *Shankhadyanjana* along with oral administration of *Shatavaryadi Churna* in the management of *Timira*- simple myopia.

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Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1.Patients presenting with signs and symptoms of Timira (Simple Myopia), described as per Ayurvedic and modern science irrespective of gender, occupation and religion.
Having spherical equivalent refraction between -0.50 diopter and -6.00 diopter.
(calculated by adding the sum of the sphere power with half of the cylinder power.) 3.Willing to comply with applying Anjana twice daily and follow the clinical trial visit schedule as per the study protocol.

Exclusion Criteria

1.Patients having high myopia (>6 Diopter) or pathological myopia (>8 Diopter) with degenerative retinal changes.
2.Patients having any other ocular pathology, e.g., strabismus, amblyopia, cataract, corneal opacity, iridocyclitis, retinal disease etc.
will be excluded.
History of any disease or syndrome that predisposes the subject to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity, DM type 1).
4.Patients with the history of refractive correction through orthokeratology & refractive surgeries, etc.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in visual acuity using LogMAR chart.	baseline, 46th day

Secondary Outcome Measures

Name	Time	Method
â€¢Change in Spherical equivalent refraction	â€¢Comparative efficacy of both the groups on asthenopic symptoms.

Trial Locations

Locations (1): All India Institute of Ayurveda
🇮🇳
Delhi, DELHI, India
All India Institute of Ayurveda
🇮🇳Delhi, DELHI, India
Shikha Sharma
Principal investigator
9179926994
drshikhasharma04@gmail.com