| CTRI Number |
CTRI/2024/08/072175 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Nasya and Tarpana in dry eye syndrome |
|
Scientific Title of Study
|
A Randomised Comparative Clinical Trial To Evaluate The Efficacy Of Jeevaniya Ghrita Nasya In Comparison To Jeevaniya Ghrita Tarpana In Shushakakshipaka 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 Kamlesh kumari |
| Designation |
pg scholar |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Department of shalakya tantra National institute of ayurveda jorawar singh gate jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9667249809 |
| Fax |
|
| Email |
olakamleshkumari0613@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna sharma |
| Designation |
Associate professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
room no.312 Department of shalakya tantra National institute of ayurveda jorawar singh gate jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8955688129 |
| Fax |
|
| Email |
appu07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamlesh kumari |
| Designation |
pg sholar |
| Affiliation |
National institute of Ayurveda Jaipur |
| Address |
Department of shalakya tantra National institute of ayurveda jorawar singh gate jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9667249809 |
| Fax |
|
| Email |
olakamleshkumari0613@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur 302002 |
|
|
Primary Sponsor
|
| Name |
National institute of Ayurveda Jaipur |
| Address |
Department of Shalakya Tantra National institute of Ayurveda jorawar singh gate jaipur 302002 |
| 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 Kamlesh Kumari |
National institute of Ayurveda, Hospital, OPD no.14 |
Jorawar singh gate, amer road jaipur, rajasthan, 302002
Department of Shalakya Tantra
Opd 14
Jaipur
RAJASTHAN |
9667249809
olakamleshkumari0613@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommittee |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: JeevaniyaGhrita, Reference: Shusrut samhita Uttar tantra chapter no.9, Shloka no.21, Route: Topical, Dosage Form: Ghrita, Dose: 6(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: 2 sittings of 7 days with 7days of gap in between. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: JeevaniyaGhrita, Reference: Shusrut samhita Uttar tantra chapter no.9, Shloka no.21, Route: Topical, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -tarpana procedure will be done as per classical method. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs and symptoms such asRukshta,Gharshana, Avildarshanam,Daha, etcandwith atleast 2 positive diagnostic test. |
|
| ExclusionCriteria |
| Details |
1. Patient with impaired eyelid function as in bell’s palsy.
2. Nocturnal legophthalmos.
3. Patient having pterygium, ectropion, corneal ulcer, glaucoma, inflammatory condition like acute conjunctivitis / keratitis.
4. Patient with rheumatoid arthritis and sjogrens syndrome.
5. patients suffering from infective ocular surface pathology.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tear film break up time will be assesed before and after the intervention to see the improvement with the help of shimmers strip. |
0th, 21st and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in overall rating of subjective ocular symptoms. |
0th, 21st and 30th day |
|
|
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 2 |
|
Date of First Enrollment (India)
|
28/08/2024 |
| 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
|
two procedures in parallel groups one group intervention procedure is nasa with jeevaniya ghrita other group intervention is tarpana procedure |