| CTRI Number |
CTRI/2020/08/027433 [Registered on: 27/08/2020] Trial Registered Prospectively |
| Last Modified On: |
26/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Dry Eye Management With Tarpan Kriyakalp Of Yashtimadhu Ghrita. |
|
Scientific Title of Study
|
A Clinical Study On The Role Of Tarpan Kriyakalp With Yashtimadhu Ghrita In The Management Of Shushkakshipaka w.s.r To Dry Eye Syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjeev Kumar Sharma |
| Designation |
Professor And HOD |
| Affiliation |
R.G.G.P.G. Ayu. College And Hospital, Paprola, Kangra (H.P) 176115 |
| Address |
P.G.Deptt. Of Shalakya Tantra R.G.G.P.G. Ayurvedic College And Hospital Paprola Kangra (H.P) 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418056005 |
| Fax |
|
| Email |
drsanjeevawasthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Kumar Sharma |
| Designation |
Professor And HOD |
| Affiliation |
R.G.G.P.G. Ayu. College And Hospital, Paprola, Kangra (H.P) 176115 |
| Address |
P.G.Deptt. Of Shalakya Tantra R.G.G.P.G. Ayurvedic College And Hospital Paprola Kangra (H.P) 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418056005 |
| Fax |
|
| Email |
drsanjeevawasthi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Devi |
| Designation |
Ms scholar 2nd year, Deptt. Of Shalakya Tantra |
| Affiliation |
R.G.G.P.G. Ayu. College And Hospital, Paprola, Kangra (H.P) 176115 |
| Address |
P.G.Deptt. Of Shalakya Tantra R.G.G.P.G. Ayurvedic College And Hospital Paprola Kangra (H.P) 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9882402633 |
| Fax |
|
| Email |
drpooja1290@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, RGGPG Ayuvedic College And Hospital Paprola, Kangra (H.P) 176115. Research Institute ISM Jogindernagar(h.p) |
|
|
Primary Sponsor
|
| Name |
Principal RGGPG Ayurvedic College And Hospital Paprola Kangra HP |
| Address |
R.G.G.P.G. Ayurvedic College And Hospital Paprola Kangra (H.P) 176115 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD |
P.G.Deptt. Of Shalakya Tantra R.G.G.P.G. Ayurvedic College And Hospital Paprola Kangra (H.P) 176115 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjeev Kumar Sharma |
Rajeev Gandhi Govt. Ayurvedic Hospital, Paprola Kangra (H.P) 176115 |
Deptt. Of Shalakya Tantra/Eye OPD/Room No.-219
Kangra
HIMACHAL PRADESH |
9418056005
drsanjeevawasthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Human) RGGPG Ayu. College And Hospital, Paprola Kangra(HP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H05||Disorders of eyelid, lacrimal system and orbit, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Yashtimadhu Ghrita |
Tarpan Kriyakalp With Yashtimadhu Ghrita For 1 Week. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients Willing To Undergo Trail.
2. Patients Presenting With Symptoms Of Shushkakshipaka w.s.r. To Dry Eye Will Be Taken Into Account. |
|
| ExclusionCriteria |
| Details |
1. Patients Not Willing To Undergo Trial.
2. Eye Disease Like- Squamous Blephritis,Corneal Ulcer,Lagopthaloms,Dacrocystitis,Uveitis, Any Stage Of Glaucoma,Allergic Conjunctivitis.
3. Patients Suffering From Dry Eye Associated With Other Ocular Disease Or Systemic Diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment Of Objective And Subjective Criteria. |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General Filling Of Well-being |
14 Days |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2020 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
I would like to publish my research trail after completion of trail as soon as possible. Patients will be selected from OPD & IPD of RGGPG Ayu. college and hospital,Paprola distt kangra(hp). 15 Patients will be registered and assessed on the basis of subjective and objective criteria. |