| CTRI Number |
CTRI/2023/10/059003 [Registered on: 23/10/2023] Trial Registered Prospectively |
| Last Modified On: |
20/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of Katakadi Anjana in the management of Dry Eye Syndrome |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Study to Evaluate the Efficacy of Katakadi Anjana and Carboxymethylcellulose Eye Drops in 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 Payal Sayagaonkar |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
PDEAs College of Ayurved and Research Centre, 3rd Floor, Shalakyatantra Department, Sector no 25, Pradhikaran Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8856059224 |
| Fax |
|
| Email |
payal7026@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandana Virkar |
| Designation |
Professor and HOD |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
PDEAs College of Ayurved and Research Centre, 3rd Floor, Shalakyatantra Department, Sector no 25, Pradhikaran Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9822199107 |
| Fax |
|
| Email |
drvirkarchandana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payal Sayagaonkar |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
PDEAs College of Ayurved and Research Centre, 3rd Floor, Shalakyatantra Department, Sector no 25, Pradhikaran Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8856059224 |
| Fax |
|
| Email |
payal7026@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre, Sector no 25, Pradhikaran Nigdi, Pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
PDEAs College of Ayurved And Research Centre, Sector no 25, Pradhikaran Nigdi, Pune 411044 |
| Type of Sponsor |
Private medical college |
|
|
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 Payal Sayagaonkar |
Ayurved Rugnalaya and Sterling Multi-Speciality Hospital, Nigdi, Pune |
Ayurved Rugnalaya and Sterling Multi-Speciality Hospital, Shalakyatantra Department, OPD no 122, Sector no 27, Pradhikaran Nigdi, Pune
Pune
MAHARASHTRA |
8856059224
payal7026@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, College of Ayurveda and Research Centre, Nigdi, Pune |
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: SARVAGATAKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | a~jjanam, अंजनमॠ| (Procedure Reference: Su. U. 18/ 64-65, Procedure details: Katakadi Anjana will be applied using anjanashalaka into both the eyes once a day in the evening for 7 days.)
(1) Medicine Name: Katakadi Anjan, Reference: Sha. Sa. U. 13/103, Route: Ocular, Dosage Form: Not Applicable, Dose: 2(mg), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Carboxymethylcellulose Eye Drops | Carboxymethylcellulose 0.5% Eye Drops 1 drop 3 times a day for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients showing minimum 3 signs and symptoms of dry eye syndrome like burning sensation, foreign body sensation, redness, blurring of vision, ocular fatigue, excessive blinking.
2. Patients fit for anjana karma |
|
| ExclusionCriteria |
| Details |
1. Known case of any congenital anomalies of the eye.
2. Any acute infective condition of the eye.
3. Severe dry eye with corneal involvement |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the efficacy of Katakadi Anjana on both eyes in the dose of 2 mg in each eye in the management of dry eye syndrome for 7 days on the Tear Film Break Up Time (TBUT)test. |
7 days of study with 2 follows on the 4th and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the adverse drug effects if any |
7 days of study with 2 follows on the 4th and 7th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/10/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Dry eye syndrome is a multifactorial disease of the ocular system. It is a result of unstable tear film, causing ocular surface inflammation and damage. At present, there is no cure for Dry Eye Syndrome. Lubricating eye drops are used to reduce the symptoms but after prolonged use may develop resistance. Ayurveda has described shushkakshipaka which can be considered as a correlation of dry eye syndrome. The Anjana that will be used in this study is said to be Prasadajanak i.e. providing lubrication to the eye. Literature include anjanakarma. Drugs have chakshushya property along with vata shamana. |