Use of Goghrita Aschyotan (installation of drops of goghrita) In Management of dry eye .

Phase 2/3

Not yet recruiting

Conditions: Disorder of lacrimal system, unspecified. Ayurveda Condition: NETRAROGAH/AKSHIROGAH,

Registration Number: CTRI/2023/05/052166

Lead Sponsor: Amol Bansode

Brief Summary: After clearance from Institutional Ethics Committee of Government Ayurved college, Nagpur, Patient visited to OPD, IPD; Casualty with complaints of rukshta, sankochit in netra and vartma, avildarshana, darunpratibodhan, gharshana, toda, bheda, shula were recruited from OPD and IPD of Shalakyatantra Department of Government Ayurved College, Nagpur.

During the informed consent process the subjects were given enough time to read patient information sheet and consent form. (ICF)subjects were also given freedom to ask the questions and all the questions were answered. If he/she agrees for participation in the study and if found fit to include during screening then he was recruited in the study. This visit was called as screening visit. On screening visit, after written informed consent, screening of subject on the basis of clinical assessment for Shushkakshipaka (i.e. Dry Eyes ) and fulfilling the diagnostic criteria. If all inclusion criteria is YES and all exclusion NO then subjects will be included a if necessary Subjects were then undergo general and systemic examinations. Study design will be Parallel Group Randomised Control Trial.

Intervention Group-

*Goghrita Aschyotana* (Eye drop) will be used for group B.

- 1 drops of *Goghrita Aschyotana* (Eye Drop) 4 times a day for first 7 days.

- 1 drops of *Goghrita Aschyotana* (Eye Drop) 3 times a day for next 7 days.

Observation up to 1 Month.

Follow up on 7th, 14th, 28thday.

Comparator Group-

**A)**Hydroxy propyl methyl cellulose Eye Drop will be used for

group A.

- 2 drops of Hydroxy propyl methyl celluloseEye Drop 4 times a day for first 7

days.

- 2 drops of Hydroxy propyl methyl celluloseEye Drop 3 times a day for next 7

days.

Duration of Trial drug- 28 days

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

1.Patient suffering from Dry Eye Syndrome.
2.Patients of age >18 years to 60 years will be selected irrespective of their gender, caste, religion, socio-economic or educational status.
3.Patients with Myopia and Hypermetropia were selected.
Patients with anatomically normal ocular structures were selected.
5.Patients who are ready to accept the treatment will be selected.

Exclusion Criteria

1.Patients suffered from other systemic or infectious diseases Will be excluded 2.Patients suffered from other extra ocular diseases like ptosis, eyelid tumor that blocks the pupil not consider for study.
3.Patients suffered from intra ocular diseases like Uveitis, Glaucoma, Cataract, Retinitis Pigmentosa, Retinal Detachment, Vitreous Haemorrhage, Diabetic Retinopathy, Hypertensive Retinopathy, Optic Atrophy, Macular Hole, Maculopathy will be excluded.
4.Other traumatic and inflammatory conditions of eye will be excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.To study the efficacy of Hydroxy propyl methyl cellulose during 28 days of study.	18 months ( follow up- baseline,7th 14th 28th day)
1.To study the efficacy of Goghrita Aschyotan In Management of Shushkakshipaka with Special Reference to Dry Eye Syndrome duration of 28 days.	18 months ( follow up- baseline,7th 14th 28th day)

Secondary Outcome Measures

Name	Time	Method
1.To study the Shushkakshipaka according to Ayurveda and Dry Eye Syndrome in modern point of view at duration of 28 days

Trial Locations

Locations (1): Government Ayurved College and Hospital
🇮🇳
Nagpur, MAHARASHTRA, India
Government Ayurved College and Hospital
🇮🇳Nagpur, MAHARASHTRA, India
Dr Amol Bansode
Principal investigator
8888924414
amols.bansode11@gmail.com