| CTRI Number |
CTRI/2024/11/076981 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| 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
|
This clinical trial will be performed to understand the add-on effect of Bhringarajaadi tail Nasya with carboxymethylcellulose eye drops in the management of Dry Eye Syndrome. |
|
Scientific Title of Study
|
A randomised controlled clinical study to evaluate the add-on effect of Bhringarajaadi tail nasya with carboxymethylcellulose eye drop 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 Shivani Gadewar |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurveda and Research Centre |
| Address |
PDEAs College of Ayurveda and Research Centre third floor shalakyatantra department sector no. 25 Pradhikaran Nigadi Pune
MAHARASHTRA
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9766042658 |
| Fax |
9766042658 |
| Email |
shivani.gadewar8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Chandana Virkar |
| Designation |
Professor and HOD shalakyatantra department |
| Affiliation |
PDEAs College of Ayurveda and Research Centre |
| Address |
PDEAs College of Ayurveda and Research Centre third floor shalakyatantra department sector no. 25 Pradhikaran Nigadi Pune
MAHARASHTRA
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9822199107 |
| Fax |
|
| Email |
drvirkarchandana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Gadewar |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurveda and Research Centre |
| Address |
PDEAs College of Ayurveda and Research Centre third floor shalakyatantra department sector no. 25 Pradhikaran Nigadi Pune
MAHARASHTRA
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9766042658 |
| Fax |
|
| Email |
shivani.gadewar8@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre sector no. 25 pradhikaran Nigadi Pune
411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurved and research centre |
| Address |
PDEAs College of Ayurved and Research Centre third floor shalakyatantra department sector no. 25 pradhikaran Nigadi Pune
Maharashtra
India
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 Shivani Rajesh Gadewar |
Ayurved rugnalaya and sterling multispeciality hospital |
shalakyatantra opd no. 122 , sector no. 27, pradhikaran nigdi, Pune
411044
Pune
MAHARASHTRA |
9766042658
shivani.gadewar8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bhringarajaadi Tail Nasya, Reference: Chakradatta Samhita, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients showing minimum 3 symptoms of Dry eye syndrome- irritation in eyes, foreign body sensation, feeling of dryness, itching, blurring of vision,excessive blinking |
|
| ExclusionCriteria |
| Details |
Known case of any congenital anomalies of the eyes, any acute infective condition of eye, severe dry eye with corneal involvement, tumours of the eye |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To identify the difference of treatment for management of dry eye syndrome.
To compare the effectiveness of treatment over period of time.
To compare the efficacy of carboxymethylcellulose eye drop with and without Bhringarajaadi tail Nasya. |
15 days treatment with 3 follow-ups on 4th , 7th and 15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Carboxymethylcellulose eye drop with Bhringrajaadi tail nasya.
To assess the efficacy of Carboxymethylcellulose eye drop without Bhringrajaadi tail nasya.
To observe the adverse effect of drug if any. |
15 days treatment with 3 follow-ups on 4th , 7th and 15th 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)
|
01/12/2024 |
| 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 multi-factorial disease of the ocular system. It results either from tear deficiency or excessive evaporation of the tear film which makes it unstable, causing ocular surface inflammation. In todays world, use of technology is increasing and leading to increased screen time which is affecting eyes badly. Polluted air, dry air , heat , dust etc are favourable for the disease causing increased number of cases of dry eyes. At present there is no permanent cure for dry eye syndrome . Lubricating eye drops are used to reduce the symptoms but prolonged use may develop resistance. Nasya is prescribed line of treatment in Eye diseases. In this study Bhringarajaadi tail nasya is taken for study to check if it can increase the efficacy of carboxymethylcellulose eye drops in dry eye syndrome when given together. |