| CTRI Number |
CTRI/2018/10/016041 [Registered on: 16/10/2018] Trial Registered Prospectively |
| Last Modified On: |
15/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Saindhava Lavana Siddha Sheetala Jala and Goksheera Seka in Management of Dry Eye |
|
Scientific Title of Study
|
Effect of netra Seka with Saindhava Lavana Siddha Sheetala Jala & Goksheera in the Management of
Shushkaakshipaaka Dry Eye Syndrome A Randomized Controlled Clinical Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajeev Sharma |
| Designation |
Pg Scholar |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre |
| Address |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre Shahpur Belgavi 590003 Karnataka
Belgaum KARNATAKA 590003 India |
| Phone |
8572007032 |
| Fax |
|
| Email |
rajeevsharma00786@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arun B Biradar |
| Designation |
Reader |
| Affiliation |
KAHERs Shri B M K Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre |
| Address |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre Shahpur Belgavi 590003 Karnataka
Belgaum KARNATAKA 590003 India |
| Phone |
8572007032 |
| Fax |
|
| Email |
arunkumar.biradar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rajeev Sharma |
| Designation |
Pg Scholar |
| Affiliation |
KAHERs Shri B M K Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre |
| Address |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre Shahpur Belgavi 590003 Karnataka
Belgaum KARNATAKA 590003 India |
| Phone |
8572007032 |
| Fax |
|
| Email |
rajeevsharma00786@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO 27 KAHERs Shri B M Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre Shahpur Belgavi 590003 Karnataka |
|
|
Primary Sponsor
|
| Name |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre |
| Address |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre Shahpur Belgavi 590003 Karnataka
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rajeev Sharma |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidalya College and Hospital |
KAHERs Shri B M K Kankanwadi Ayurveda Mahavidalya Post Graduate Studies and Research Centre Shahpur Belgavi 590003 Karnataka
Belgaum KARNATAKA |
8572007032
rajeevsharma00786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutnal Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dry Eye Syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Goksheera |
Goksheera seka
one time a day
route of administration- external application |
| Intervention |
Saindhava Lavana |
Saindhava Lavana with sheetal jala dose 0.9 % one time a day
route of admistration external application
duration- 7 days
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients fulfilling the diagnostic criteria of Shushkaakshipaaka (Dry Eye Syndrome)
2 20 to 40 years of age group
3 Irrespective of sex occupation religion will be included
|
|
| ExclusionCriteria |
| Details |
 Age less than 20 years and more than 40 years
 Severe conditions like Steven Johnson’s syndrome, Chemical-Thermal-Radiation burns, idiopathic atrophy, Trachoma, Ocular pemphigoid
 Corneal epitheliopathies like Neuroparalytic keratitis, post-herpatic / post-measles infection of cornea,
 Conjunctival epitheliopathies like Pterygium, Pseudo-pterygium, Tumours, Retention cysts, chronic low grade bacterial / viral conjunctivitis
 Lid abnormalities like Meibominitis, Blepharitits, Facial nerve palsy, Lagophthalmous,
 Lacrimal gland diseases like infiltration of gland with sarcoidosis, lymphoma, leukemia and amyloidosis, congenital Alacrima
 Vitamin A deficiency, effect of the drugs like atropine, antihistamine, diuretics
 Specific systemic infections like Tuberculosis, Leprosy, Hypertension, RA, Diabetes mellitus, etc
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The effect of Saindhava Lavana Seka might be helping in reducing inflammation and hence restoration function of goblet cells and mucin secreting cells of conjunctiva might restore functioning normally
Thus might restore moisture and health of ocular surface |
1 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Due to expected normalcy the tear film components and tear fluid quantity and pattern of flow may restore |
1 week |
|
|
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)
|
01/11/2018 |
| 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
|
Yet to start clinical trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Yet to start clinical trial Watering in the eye
itself is one of the clinical features of Dry Eye Syndrome, which is actually a
reflex watering, induced due to dryness. This phenomenon keeps the patient away
from the doctor and makes the disease chronic. In early stages, clear watering
occurs, whereas in due course these secretions become turbid and turns into
mucoid with filamental debris (i.e. increased osmolarity of tears with inflammatory
ocular surface disorder).
Tear deficiency,
evaporative troubles, altered food – behavioural regimen, profession and
modified life style contribute a lot for this trouble. In modern medicine, Dry Eye Syndrome is palliative
manageable condition. Selection of the particular tear supplement is the only
non-invasive treatment.
In present era no one
is having enough time and patience to go for lengthy procedures like Nasya,
Anjana, Aschyotana, Tarpana, etc for the non-acute conditions like Dry Eye
Syndrome.
Hence, there is great
need of safe, effective, short-term, easily available and that can be done easily.
Ghritamanda Aschyotana is one of such procedure which mimics as modern
management and easily acceptable procedure.
Saindhava Lavana is
having Kapha Lekhana, Shodhana,
Kledahara, Chaakshushya and Shothahara
property. It is being used as an ingredient of many ocular pharmaceutical preparations.
Considering all above,
this study is planned to find the comparative efficacy of Saindhava Lavana Siddha Sheetala Jala & Goksheera in the management of Shushkaakshipaaka
with special reference to Dry Eye Syndrome. |