| CTRI Number |
CTRI/2023/02/049505 [Registered on: 07/02/2023] Trial Registered Prospectively |
| Last Modified On: |
07/02/2023 |
| 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
|
Effect of application of Aloe Vera pulp (korfad) with Rakta Chandan and Triphala powder over eyelids in the treatment of DIGITAL EYE STRAIN. |
|
Scientific Title of Study
|
A Randomized Controlled Trial On Effect Of Kumaryadi Bidalaka In Comparison With CARBOXYMETHYLCELLULOSE Eye drops In The Treatment Of Digital Eye Strain W.S.R To SHUSHAKSHIPAKA. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priya Bhardwaj |
| Designation |
Pg Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya |
| Address |
Opd No. 11
Shalakya Tantra Department
Shri Ayurved Mahavidyalaya
kridasquare, Hanuman Nagar
Nagpur
Shri Ayurved Mahavidyalaya
kridasquare Hanuman Nagar
Nagpur -440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
8368018073 |
| Fax |
|
| Email |
pb300995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Govind D Tundalwar |
| Designation |
Associate professor |
| Affiliation |
Shri Ayurved Mahavidyalaya |
| Address |
Opd No. 11
shalakya Tantra Department
Shri Ayurved Mahavidyalaya
kridasquare Hanuman Nagar
Nagpur
Shri Ayurved Mahavidyalaya
kridasquare Hanuman Nagar
Nagpur -440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9860166089 |
| Fax |
|
| Email |
drgovind2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Bhardwaj |
| Designation |
Pg Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya |
| Address |
Opd No. 11
Shalakya Tantra Department
Shri Ayurved Mahavidyalaya
kridasquare Hanuman Nagar
Nagpur
Shri Ayurved Mahavidyalaya
kridasquare Hanuman Nagar
Nagpur -440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
8368018073 |
| Fax |
|
| Email |
pb300995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd No. 11, Shalakya Tantra Department ,Shri Ayurved Mahavidyalaya Hanuman Nagar Nagpur-440024 |
|
|
Primary Sponsor
|
| Name |
Dr. Priya Bhardwaj |
| Address |
Opd No. 11
Shalakya Tantra Department
Shri Ayurved Mahavidyalaya
kridasquare, Hanuman Nagar
Nagpur -440024 |
| 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 Priya Bhardwaj |
Shri Ayurved Mahavidyalaya |
Opd No. 11
Shalakya Tantra Department
Shri Ayurved Mahavidyalaya
kridasquare, Hanuman Nagar
Nagpur
Nagpur
MAHARASHTRA |
8368018073
pb300995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Of Shri Ayurved Mahavidyalaya, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H041||Other disorders of lacrimal gland. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Carboxymethylcellulose eyedrop | Carboxymethylcellulose eyedrop - 1 drop TDS | | 2 | Intervention Arm | Procedure | - | Bidalaka | (Procedure Reference: Sharangdhara samhita uttartantra, Procedure details: Sharangdhara samhita uttartantra, Procedure details: Kumaryadi Bidalaka -Triphala churna and rakta chandan churna will be mixed with aloe vera pulp and fine paste will be applied over the eyelids.))
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a)Patients having signs & symptoms of Digital Eye Strain.
b)Patients having age group of 16-60 years irrespective of their sex, caste, economical status & residence status.
c)Patients willing for treatment.
d)Patients having normal vision with or without spectacles. |
|
| ExclusionCriteria |
| Details |
a)Patients not willing for clinical trial.
b)Patient suffering from other systematic disorders.
c)Patient undergone any intra ocular & extra ocular surgeries.
d)Patients having any ocular infectious /inflammatory disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study may provide use of kumaryadi Bidalaka as an effective treatment in relieving the symptoms of Digital Eye Strain. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Kumaryadi Bidalaka could be found effective in increasing the tear production by stimulating tear glands which are present in eyelids . |
1 month |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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 3 |
|
Date of First Enrollment (India)
|
08/02/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an open label randomized controlled trial in which patients of Digital Eye strain would be taken from shalakyatantra opd no. 11 of shri Ayuved Mahavidyalaya Nagpur. Kumaryadi bidalaka will be given to the trial group for 15 days and Carboxymethylcellulose eyedrop will be given to the control group for 15 days and the results would be compared on 30 th day. This study may provide use of kumaryadi Bidalka as an effective treatment in relieving the symptoms of digital eye strain and could be found effective in increasing the tear production. |