A study on the effect of Shatavari Siddha Ghrita eye drops in treating Dry Eye Syndrome.

Phase 2

Recruiting

• Conditions: Other disorders of lacrimal gland. Ayurveda Condition: SUSHKAKSHIPAKAH,

• Registration Number: CTRI/2025/04/085498
• Lead Sponsor: Dr Niranjan Ulhas Shinde

Brief Summary

This study is a randomised controlled clinical, parallel group,open label, single site trial to study the effect of Shatavari Siddha Ghrita Aschyotana in the management of Shushkakshipaka with special reference to Dry Eye Syndrome.

Shushkakshipaka is a disease mentioned in Ayurveda under Sarvagata Netraroga which is caused by vitiated Vata Dosha according to Acharya Sushruta and by vitiated Vata and Pitta doshas according to Acharya Vagbhata. It can be co related to Dry Eye Syndrome mentioned in modern texts.

It is becoming more common due to factors like excess usage of digital devices, lifestyle changes, stress,night shifts,laser surgeries.

Current tear substitutes offer only temporary relief without addressing the root causes of dry eye disease. Many ophthalmic products containing preservatives increase the risk of adverse effects with prolonged use.



Acharya Vagbhata states that Aschyotana is a vital Kriyakalpa for eye rejuvenation, which improves eye health by nourishing them and is the first line of treatment for most eye diseases.

Given its potential effectiveness and ease, there is a need for more indepth research on Aschyotana making it a promising treatment for eye care and its disease management.This is why the topic was selected for further study.



Shatavari Siddha Ghrita can be used here in management of Dry eye syndrome as Shatavari and Ghrita have Chakshushya, Rasayana, Balya and Tridoshaghna properties.

Its ability to form a protective oily layer on the ocular surface makes it effective in reducing tear evaporation and preventing further damage.



Patient having age group of 18 to 60 years irrespective of gender and occupation and having classical sign and symptoms of Shushkakshipaka and positive specific test as per the prepared proforma will be selected randomly for the present study.

Method of assessment includes Subjective criteria and objective criteria as follows-

Subjective criteria-

1)Shushkata ( Dryness of eyes)

2)Daha ( Burning sensation)

3)Raga ( Redness or congestion)

4)Gharsha ( Foreign body sensation)

5)Kunita ( Photophobia )



Objective criteria-

1)Schirmer Test 1 and

2)Tear film break up time



Consent would be obtained from each patient prior to study. Computerised generated Sampling technique will be used.



The total sample size for study will be taken as 70. It will be divided

into two groups as:

Group A as the TRIAL group receiving Shatavari Siddha Ghrita Aschyotana topically ,12 drops, OD for 7 days.



Group B as the CONTROL group receiving Polyethylene Glycol 400 and Propylene Glycol eye drops topically,3 drops, QID for 7 days.



Observation of each patient will be done on 0th,7th day and follow up on 14th day based on pre designed proforma and assessment criterias for both the groups.



The study would evaluate the impact of Shatavari Siddha Ghrita Aschyotana on the signs and symptoms of Shushkakshipaka after 7 days of treatment.

Also it would study where the trial drug stand in comparison to a standard modern drug at the end of study.



Result of study will be drawn on the basis of assessment criteria and statistical analysis. Discussion will be done on the basis of observations and result obtained.Summary will be drawn and conclusion will be drawn on basis of statistical analysis and will be unbiased.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-05
• Last Update Posted: 2025-04-21

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 1)Patients having classical symptoms of Shushkakshipaka like Shushkata,Daha,Raga, Gharsha,Kunita.
• 2)Patients with signs like debris or mucin strands in tear film and conjunctival congestion.
• 3)Patients with positive specific clinical tests like Schirmer I test and tear film break up time test as per the prepared proforma will be selected randomly for the present study.

Exclusion Criteria

• 1)Patients presenting with Dry eye complicated with acute or infective conjunctivitis or keratitis.
• 2)Patients suffering from specific ocular or systemic diseases.
• 3)Traumatic conditions or major injury due to foreign body.
• 4)Patient recently undergone ocular surgery.
• 5)Patients using contact lenses.
• 6)Systemic diseases like DM, HIV, HBsAG.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the effect of Shatavari Siddha Ghrita Aschyotana in signs and symptoms of Shushkakshipaka with the help of assessment criteria.	7 days

Secondary Outcome Measures

Name	Time	Method
Where the trial group stands in comparison with control group in reduction of signs and symptoms of Shushkakshipaka.	18 months

Trial Locations

Locations (1)

SMBT Ayurved College and Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

SMBT Ayurved College and Hospital

🇮🇳Nashik, MAHARASHTRA, India

Dr Niranjan Ulhas Shinde

Principal investigator

7276227957

nushinde.12345@gmail.com