| CTRI Number |
CTRI/2024/08/073077 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Saindhavadi Ashchyotana (eye drops)in Shushkakshipak (Dry eye syndrome) |
|
Scientific Title of Study
|
Randomized Controlled Trial of Saindhavadi Ashchyotana in Shushkakshipak 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 |
Jyoti Rajendra Londhe |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College And Hospital |
| Address |
Department of Shalakya Tantra SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
09922680877 |
| Fax |
|
| Email |
drpvjagtap@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 |
| Address |
Department of Shalakya Tantra SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
09823388270 |
| Fax |
|
| Email |
dr.tusharfirke@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti Rajendra Londhe |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College And Hospital |
| Address |
Department of Shalakya Tantra SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
09922686877 |
| Fax |
|
| Email |
drpvjagtap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra- SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403 Maharashtra |
|
|
Primary Sponsor
|
| Name |
Jyoti Rajendra Londhe |
| Address |
Department of Shalakya Tantra SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jyoti Rajendra Londhe |
SMBT Ayurved College & Hospital |
OPD no 8 Department of Shalayatantra SMBT Ayurved Collge And Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India
Nashik
MAHARASHTRA |
09922680877
drpvjagtap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H049||Disorder of lacrimal system, unspecified. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | AScyotanam, आशà¥à¤šà¥à¤¯à¥‹à¤¤à¤¨à¤®à¥ | (Procedure Reference: Bhaishajya ratnavali, Procedure details: Saidhavadi Ashchyotan 10 drops two times ib both eyes from height of two angul held for 10 minutes at a time for 21 days)
(1) Medicine Name: Saindhavadi Ashchyotana, Reference: Bhaishajya Ratnavali, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 10(drops), Frequency: bd, Duration: 21 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | polyethelene glycol 400 and Propylene glycol eye drops | Eye drops with the composition of Polyethelene glycol 400 and Propylene glycol was poured in both eyes in the doses of 2 drops 2 times and held for 10 minutes each time for 21 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of shushkakshi pak eg Rukshata(dryness) Daah( burning sensation) Avildarshan(blurring of vision) Kruchounmilan( unable to open eyes easily)
|
|
| ExclusionCriteria |
| Details |
Congenital Anomalies of eye
patients using anti histamines hormones anti psychotics medications
Associated with an inflammatory and infective ocular disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the effect the Saindhavadi Ashchyotana in reducing the signs and symptoms of Shushkakshi paak |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Whether there is difference in the effect of trial group in comparison group |
18 months |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
09/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/09/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Shushkakshipak is a classical clinical condition in day to day prcactice in ophthalmology. The lakshanas of shushkakshipak can be equated with the signs and symptoms of Dry Eye syndrome. It is a common condition characterized by disturbances of tear film. The prevalence of Dry eye syndrome is increasing day by day due to use of gadgets. In Ayurvedic Samhitas the treatment of shushkakshi pak is done with the application of saindvadi Ashchyotana ( saindavadi eye drops), hence the trial drug is taken as Saindavadi ashchyotan in group A ( Trial group). In modern science Polyethiline Glycol 400 & Propyline Glycol eye drops are indicated for a complete curable line of treatment against any limitations hence this drug is taken as gold standard control in group -B. In group A the Saindavadi ashchotan will be use as eye drop - 10 drops twice a day for 21 days. In group -B Polyethiline Glycol 400 & Propyline Glycol eye drops will be used 2 drops twice a day for 21 days as intervention. 98 no of subjests will be recruited in two groups - group A- 49, Group -B 49 In each groups. Observations will be done on 7th, 14th & 21st days.Results of the study will be drown on basis of criteria of assessment and statistical analysis. Duscussion will be done on basis of observations and results obtained during treatment. Summary will be drown and whole thesis work will be summarized. Conclussion will be drown strictly on basis of stastical analysis and it will be unbiased. |