Evaluation of the efficacy of Vimala varti anjana and Triphaladi compound with and without Yashada bhasma in the management of Timira simple myopia an open labelled double arm randomised clinical trial

EVALUATION OF THE EFFICACY OF VIMALA VARTI ANJANA AND TRIPHALADI COMPOUND WITH AND WITHOUT YASHADA BHASMA IN THE MANAGEMENT OF TIMIRA SIMPLE MYOPIA AN OPEN LABELLED DOUBLE ARM RANDOMISED CLINICAL TRIAL

RESEARCH QUESTION

What is the efficacy of Vimala Varti Anjana and Triphaladi compound with and without Yashada Bhasma in the management of Timira Simple Myopia

HYPOTHESIS

Application of Vimala Varti Anjana along with oral administration of Triphaladi compound and Yashada Bhasma for a duration of six weeks, will be more effective than application of Vimala Varti Anjana along with oral administration of Triphaladi compound for a duration of six weeks in the management of Timira simple myopia.

NULL HYPOTHESIS H0

Application of Vimala Varti Anjana along with oral administration of Triphaladi compound and Yashada Bhasma orally for a duration of six weeks, do not have better efficacy than application of Vimala Varti Anjana along with oral administration of Triphaladi compound for a duration of six weeks in the management of Timira simple myopia.

ALTERNATE HYPOTHESIS H1

Application of Vimala Varti Anjana along with oral administration of Triphaladi compound and Yashada Bhasma for a duration of six weeks, will be more effective than application of Vimala Varti Anjana along with oral administration of Triphaladi compound for a duration of six weeks in the management of Timira simple myopia.

NEED OF STUDY

Myopia is caused due to varied reasons like elongation of the posterior section of the eye ball and also certain degenerative changes in the eye. Most patients elect to wear eyeglasses or contact lenses to neutralize refractive error but it fails to decrease the risk of posterior segment sequel of myopia. The

use of spectacles which neither cures nor prevents the progression of the pathology. Till date no medicine has been invented to preserve the sight of the patients affected with myopia. An alternative is to permanently alter the refractive properties of the cornea by performing laser in situ keratomileusis

LASIK or photo-refractive keratectomy PRK. These measures are not fully safe from complications. Surgical intervention although popular, is not successful in all individuals , complications such as dry eye and night glare can be annoying and is not affordable to everyone.

OBJECTIVES OF THE RESEARCH

Primary objective

To evaluate the efficacy of Vimala Varti Anjana and Triphaladi compound with and without Yashada Bhasma orally on the cardinal features of Timira i.e. blurring of vision using clinical refraction.

Secondary objective

To compare the efficacy of Vimala Varti Anjana and Triphaladi compound with and without Yashada Bhasma orally on other symptoms of Timira simple myopia i.e. netrasrava, netrayasa and netradaha.

TYPE OF STUDY DESIGN

Open labelled double arm randomized clinical trial

Group 1- Application of Vimala Varti Anjana along with oral administration of Triphaladi Compound and Yashada Bhasma.

Group 2- Application of Vimala Varti Anjana along with oral administration of Triphaladi Compound.

STUDY SETTING

Department of Shalakya Tantra of AIIA, Sarita Vihar, New Delhi

STUDY POPULATION

Patients attending the OPD and IPD of the department of Shalakya Tantra, and those referred from other departments of All India Institute of Ayurveda, New Delhi, shall be selected irrespective of gender, religion, race, occupation, etc. based on the diagnostic, selection criteria and be enrolled in the study.

Sample size

24 cases in each group. Total 48

INCLUSION CRITERIA

1. The patients presenting with classical features of Simple myopia after proper screening with the help of Snellen’s Chart, Retinoscopy and Auto refractometry will be selected irrespective of Gender, Occupation, religion etc.

2. Patients aged between 10 to 30 years.

3. Patients having simple Myopia -0.50 DS to -3.00 DS

EXCLUSION CRITERIA

1. Hypermetropia, Astigmatism, Presbyopia.

2. Simple Myopia more than -3.00 DS, Pathological Myopia.

3. Patient with any systemic disease like HTN, DM, TB etc.

4. Patient with any other ocular pathology like Cataract, Glaucoma, retinal pathology etc.

5. Functional Myopia

6. Pregnant and Lactating Mother.

Laboratory Investigations

For the purpose of assessing the general condition of the patient and to exclude other pathologies, the following investigations will be performed in all the selected patients before trial.

Routine examination

-CBC Hb%, TLC, DLC, ESR

CRITERIA FOR ASSESSMENT

Subjective parameters

1. Indistinct distance vision Avyaktarupadarshana Duram na pashyate

2. Blurred vision Vihwala Darshana

3. Floaters Makshikadi abhuta dravya darshana

4. Diplopia/ Polyopia Dwidha Bahuvidha darshana

5. Headache Shirobhitapa

6. Eye strain Netrayasa

7. Watering Netrasrava

8. Burning sensation in eyes Netradaha

Objective parameters

1. Unaided and best corrected visual acuity Auto-refractometry and subjective refraction,

2. A scan

3. K1 and K2 values Keratometry

4. Intra ocular tension NCT/Schiotz tonometer

5. Retinoscopy finding

DURATION OF TRIAL

The total duration of the trial will be 9 weeks

6 weeks intervention, 3 weeks follow up

FOLLOW UP:

• After completion of 6 weeks of intervention, the patient will be followed for 3 weeks.

• Follow-up of the patients will be ensured by telephonic communication or by creating a WhatsApp group. The compliance of the patient will be noted in a separate sheet provided to them. For ensuring the compliance a chart shall be prepared and given to the patient.

ASSESSMENT TIME

Before treatment, the 2nd week, the 4th week, and 6th week

Follow-up on the 3rd week.

PRIMARY ENDPOINT

0.50 D change in the Clinical Refraction in patients of Timira Simple Myopia.

SECONDARY ENDPOINT

Change in the other clinical features of Timira netrasrava, netrayas and netradaha.

75percent improvement in the Clinical features in the patients of Timira Simple Myopia.