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CTRI Number  CTRI/2025/04/085498 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On: 21/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study on the effect of Shatavari Siddha Ghrita eye drops in treating Dry Eye Syndrome. 
Scientific Title of Study   A randomised controlled clinical trial to study the effect of Shatavari Siddha Ghrita Aschyotana in the management of Shushkakshipaka with special reference to Dry Eye Syndrome. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Niranjan Ulhas Shinde 
Designation  Post Graduate Student 
Affiliation  SMBT Ayurved College and Hospital, Dhamangaon, Igatpuri,Nashik 422403 
Address  OPD no 16, Department of Shalakyatantra,SMBT Ayurved College and Hospital, Dhamangaon , Igatpuri, Nashik 422403

Nashik
MAHARASHTRA
422403
India 
Phone  7276227957  
Fax    
Email  nushinde.12345@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tushar Vishnu Firke 
Designation  Professor and Head of Department 
Affiliation  SMBT Ayurved College and Hospital, Dhamangaon, Igatpuri,Nashik 422403 
Address  OPD no 16, Department of Shalakyatantra,SMBT Ayurved College and Hospital, Dhamangaon , Igatpuri, Nashik 422403

Nashik
MAHARASHTRA
422403
India 
Phone  9823388720  
Fax    
Email  dr.tusharfirke@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Niranjan Ulhas Shinde 
Designation  Post Graduate Student 
Affiliation  SMBT Ayurved College and Hospital, Dhamangaon, Igatpuri,Nashik 422403 
Address  OPD no 16, Department of Shalakyatantra,SMBT Ayurved College and Hospital, Dhamangaon , Igatpuri, Nashik 422403

Nashik
MAHARASHTRA
422403
India 
Phone  7276227957  
Fax    
Email  nushinde.12345@gmail.com  
 
Source of Monetary or Material Support  
Department of Shalakyatantra,SMBT Ayurved College and Hospital, Dhamangaon, Igatpuri, Nashik 422403 
 
Primary Sponsor  
Name  Dr Niranjan Ulhas Shinde 
Address  OPD No 16, Department of Shalakyatantra,SMBT Ayurved College and Hospital, Dhamangaon, Igatpuri,Nashik 422403 Nashik Maharashtra 422403 India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Niranjan Ulhas Shinde  SMBT Ayurved College and Hospital  OPD no 16,Department of Shalakyatantra, SMBT Ayurved College and Hospital, Dhamangaon, Igatpuri, Nashik 422403
Nashik
MAHARASHTRA 
7276227957

nushinde.12345@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMBT Ayurved College and Hospital, Dhamangaon, Igatpuri  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H041||Other disorders of lacrimal gland. Ayurveda Condition: SUSHKAKSHIPAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shatavari Siddha Ghrita , Reference: Chakradutta, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 12(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Shatavari Siddha Ghrita Aschyotana 12 drops, OD for 7 days.
2Comparator Arm (Non Ayurveda)-Polyethylene Glycol 400 and Propylene Glycol eye drops.Eye drops administered topically, 3 drops, QID for 7 days.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
Where the trial group stands in comparison with control group in reduction of signs and symptoms of Shushkakshipaka.  18 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   02/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.



 
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