| CTRI Number |
CTRI/2024/07/071717 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurveda management of dry eye with the help of yashtimadhu taila nasya and haridradi ksheera seka |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of yashtimadhu taila nasya and haridradi ksheera seka in Shushkakshipaka w.s.r to dry eye |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHIVANI KAPURKAR |
| Designation |
MS Scholar |
| Affiliation |
Dr. B.R.K.R. Govt. Ayurveda Hospital |
| Address |
Room no.11, Dr.B.R.K.R. Govt. Ayurveda Hospital, Erraggada, Hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
9440896153 |
| Fax |
|
| Email |
kapurkarshivani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ch Ramadevi |
| Designation |
Professor and HOD |
| Affiliation |
Dr. B.R.K.R Govt. Ayurveda Hospital |
| Address |
Room no.11, Dr.B.R.K.R. Govt. ayurveda Hospital, Erraggada, Hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
9849164668 |
| Fax |
|
| Email |
rama.sreerangam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ch Ramadevi |
| Designation |
Professor and HOD |
| Affiliation |
Dr. B.R.K.R Govt. Ayurveda Hospital |
| Address |
Room no 20, Dr. B.R.K.R. Govt. Ayurveda Hospital, Erraggada Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9849164668 |
| Fax |
|
| Email |
rama.sreerangam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.B.R.K.R Govt. Ayurveda College and hospital, Opp ESI Hospital ,towards S R Nagar, AG Colony Rd, Sultan Nagar, Erragadda, Hyderabad, Telangana 500018 |
|
|
Primary Sponsor
|
| Name |
Dr BRKR Govt ayurveda college and hospital |
| Address |
Dr. B.R.K.R. Govt. ayurveda college and hospital, Erraggada Hyderabad |
| Type of Sponsor |
Government 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 Kapurkar |
Dr. B.R.K.R. Govt. Ayurveda Hospital |
Room no. 11 Department of shalakyatantra
Hyderabad
TELANGANA |
9440896153
kapurkarshivani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Dr. BRKR govt ayurveda college |
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: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ and Seka | (Procedure Reference: Yogaratnakara netrarogachikitsa sloka 3-5, Procedure details: NASYA KARMA- nasya will be done with yashtimadhu taila Type of Nasya-Brimhana nasya time of administration- once a day (morning) dose- 6 drops in each nostril duration-42days (7days 3 sittings with interval of 7days
SEKA- will be done with haridradi ksheera poorvakarma- patient will be asked to lie in supine position pradhan karma- the required quantity of prepared drug for seka accordingly will be taken in the seka patra and will be poured on closed eyes from height of 4 angulas in a thin and continuous stream for 10minutes. pashchat karma-after completion of seka eyes will be cleaned with cotton and patient will be advised to close their eyes and rest for few minutes duration-42days( 7days 3 sittings with interval of 7 days)
Alternate week nasya and seka will be done)
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) patients aged above 18 and below 60yrs
b) patients presenting mild to moderate symptoms of dry eye ( foreign body sensation, pricking sensation, feeling of dryness, tranient blurring of vision, and burning sensation) who are willing to participate. (schimmers test 5-15mm)
c) irrespective of gender and religion |
|
| ExclusionCriteria |
| Details |
a) Patient age below 18 and above 60 years.
b) Patient showing severe symptoms of dry eye are excluded. ( Schirmers test Less than 5mm).
c) Congenital anomalies of eye.
d) Any ocular surface pathology, infections and systemic diseases.
e) one who is using contact lens. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms of dry eye |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life of patient |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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="5"
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
|
This is a randomized
clinical trial on the effect of Yashtimadhu taila nasya and Haridradi ksheera
seka in shushkakshipaka w.s.r. to dry eye in patients who will be clinically diagnosed and confirmed cases of dry eye enlisted in inclusion criteria will
be in single group of 30 patients. They will be given Yashtimadhu taila
nasya 6 drops in each nostril in morning and haridradi Ksheera Seka from
the height of 4 angula. 1 week Nasya followed by Seka after one week. This will be continued for 6 weeks (42 days). Follow up upto 42 days in interval of 21 days. |