| CTRI Number |
CTRI/2023/07/055410 [Registered on: 20/07/2023] Trial Registered Prospectively |
| Last Modified On: |
19/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An Ayurvedic Management Of Dry Eye Syndrome |
|
Scientific Title of Study
|
A Comparative Study To Evaluate The Efficacy Of Rajanyadi Seka And Lodhra Seka With Bibhitaki Ghrita Internally
In The Management Of Shushkakshipaaka W S R 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 Shruti D Gangannavar |
| Designation |
P G Scholar |
| Affiliation |
Government Ayurveda Medical College Bengaluru |
| Address |
Department Of PG Studies In Shalakya Tantra Government Ayurveda Medical College Dhanwantari Road Majestc Bengaluru
Bangalore
KARNATAKA
560009
India
Bangalore
KARNATAKA
560009
India |
| Phone |
9591317803 |
| Fax |
|
| Email |
padmamurthy5674@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rathi S |
| Designation |
Professor |
| Affiliation |
Government Ayurveda Medical College Bengaluru |
| Address |
Department of PG Studies in Shalakya Tantra Government Ayurveda
Medical College, Dhanwantari Road, Majestc, Bengaluru
Bangalore
KARNATAKA
560009
India
Bangalore
KARNATAKA
560009
India |
| Phone |
8970779550 |
| Fax |
|
| Email |
drrathi.s@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti D Gangannavar |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College Bengaluru |
| Address |
Department Of PG Studies In Shalakya Tantra Government Ayurveda Medical College Dhanwantari Road Majestc Bengaluru
Bangalore
KARNATAKA
560009
India
Bangalore
KARNATAKA
560009
India |
| Phone |
9591317803 |
| Fax |
|
| Email |
padmamurthy5674@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room Number 11 Shalakya Tantra Opd Government Ayurveda Medical College
Dhanwantari Road Majestc Bengaluru |
|
|
Primary Sponsor
|
| Name |
Dr Shruti D Gangannavar |
| Address |
Room No 11 Department Of Shalakya Tantra Government Ayurveda Medical College Dhanwantari Road Majestc Bengaluru |
| 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 Shruti D Gangannavar |
Sri Jayachamarajendra Government Ayurveda And Unani Hospital |
Government Ayurveda Medical College Dhanwantari Road Majestc Bengaluru
Bangalore
KARNATAKA |
9591317803
padmamurthy5674@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Ayurveda Medical College Bangalore |
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 | Procedure | - | netrapariSheka, नेतà¥à¤°à¤ªà¤°à¤¿à¤·à¥‡à¤• | (Procedure Reference: Sharangdhar , Procedure details: Eye Should Be Cleaned With Luke Warm Water And Seka Should Be Done As Sookshmadhara Using Seka Dravya For 600 Matrakala From 4 Angul Hight For 7 Days)
(1) Medicine Name: Rajanyadi Seka, Reference: Yoga Rathnakara, Route: Ocular, Dosage Form: Ksheerpaka, Dose: 500(ml), Frequency: od, Duration: 14 Days(2) Medicine Name: Lodhra Seka, Reference: Astanga Hridaya, Route: Ocular, Dosage Form: Ksheerpaka, Dose: 500(ml), Frequency: od, Duration: 14 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bibitaki Ghrita, Reference: Yoga Rathnakara, Route: Oral, Dosage Form: Ghrita, Dose: 12(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All The Patients Presenting The Signs And Symptoms Of The Sushkakshipaka Will BE Taken For The Study Clinical Trails Irrespective Of Gender Caste Religion Socio Economic Status |
|
| ExclusionCriteria |
| Details |
1 Injry To Eyes
2 Systemic Disorders Like Rheumatiod Arthritis SLE Sjogrens Syndrome
3 Congenital Alacramia Associated With Any Inflamatory Conditions And
4 Infective Other Conditions Like Glucoma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
schirmers test
Tearfilm Break Up Time |
65 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessed using self generated scoring
1.Feeling Dirt In The Eyes
pricking Pain
3.Difficulty In Opening And Closing Of Eyelids
4.Dryness Of Eyes
5.Painfull Lid And Eyes
6.Photophobia
7.Burning sensation |
65 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
28/07/2023 |
| 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="0"
Months="0"
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
|
Sushkakshipaka is one of the Vataja(Sushruta)1 /Vata-pittaja(Vagbhata) Sarvagata, Sadhya
Netrarogas. Features of Shushkakshipaka includes hard and dry eye lids, found drooping; blurred
vision and difficulty to open the eyes with foreign body sensation2 . The Lakshanas of
Shushkakshipaka can be equated with the signs and symptoms of Dry Eye Syndrome. Dry Eye is a
disorder of the tear film due to tear deficiency or excessive tear evaporation which causes damage
to the inter palpebral ocular surface and is associated with symptoms of ocular discomfort. The
climate of tropical India and globalization along with the sprout of millions of IT professionals are
making Dry Eye Syndrome, a fast growing disease, as all these leads to increased tear evaporation
(due to dry wind, air conditioning, decreased blink reflex etc.) along with other causes like aqueous
tear deficiency, mucin deficiency, lipid deficiency, impaired lid function, irregular corneal surface
etc.The prevalence of DES in India is higher than the global prevalence and ranges from 18.4% to
54.3%. To explore effective solution in Ayurveda is the need of the hour as is no complete cure for
Dry eyes in contemporary medicines at present.Some of the treatment modalities which have been
tried with variable results include supplementation with tear substitutes, topical cyclosporine,
mucolytic, topical retinoid, preservation of existing tears etc. along with correction of lid
abnormalities, which are not long lasting and thus long-term usage is recommended. The treatment
modalities that are told in classics for this are Ghritapaana, Tarpana, Seka, Aschotana, Anjana etc.
which are known to increase the stability of tear film and give relief from the symptoms of
Shushkakshipaka. Hence this study is taken to overcome the challenges in treating the dry eye syndrome. |