| CTRI Number |
CTRI/2021/05/033884 [Registered on: 31/05/2021] Trial Registered Prospectively |
| Last Modified On: |
29/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Ghritkumaryadi Aschyotan (drops)in Shushkakshipaka w.s.r. to Dry Eye Syndrome. |
|
Scientific Title of Study
|
A Clinical study on the effect of Ghritkumaryadi Aschyotan (drops)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 Sukhdev Singh |
| Designation |
Sr. Lecturer Shalakya Department |
| Affiliation |
RGGPG Ayurvedic College Paprola |
| Address |
RGGPG Ayurvedic College and Hospital Paprola Mahalaxmi traders near KCC Bank VPO Paprola Teh Baijnath Distt Kangra
Himachal Pradesh
RGGPG Ayurvedic College and Hospital Paprola Mahalaxmi traders near KCC Bank VPO Paprola Teh Baijnath Distt Kangra
Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418471230 |
| Fax |
|
| Email |
drsukhdev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukhdev Singh |
| Designation |
Sr. Lecturer Shalakya Department |
| Affiliation |
RGGPG Ayurvedic College Paprola |
| Address |
RGGPG Ayurvedic College and Hospital Paprola Mahalaxmi traders near KCC bank VPO Paprola Teh Baijnath Distt Kangra HP
RGGPG Ayurvedic College and Hospital Paprola Mahalaxmi traders near KCC Bank VPO Paprola Teh Baijnath Distt Kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418471230 |
| Fax |
|
| Email |
drsukhdev@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailza Kumari |
| Designation |
PG Scholar Shalakya Tantra Department |
| Affiliation |
RGGPG Ayurvedic College Paprola |
| Address |
RGGPG Ayurvedic College and Hospital Paprola Mahalaxmi traders near KCC Bank VPO Paprola Teh Baijnath Distt Kangra HP
RGGPG Ayurvedic College and Hospital Paprola Mahalaxmi traders near KCC Bank VPO Paprola Teh Baijnath Distt Kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9459709287 |
| Fax |
|
| Email |
shailzathakur174@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath pharmacy Paprola Distt kangra HP
Charak Pharmacy RGGPG Ayurvedic college and Hospital Paprola Distt Kangra HP
Research institute in ISM Joginder Nagar HP
|
|
|
Primary Sponsor
|
| Name |
Principal |
| Address |
RGGPG Ayurvedic College and Hospital Paprola |
| 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 Sukhdev Singh |
RGGPG Ayurvedic College and Hospital Paprola |
Room No.-219 Department of shalakya tantra RGGPG Ayurvedic Medical College and Hospital
Kangra
HIMACHAL PRADESH |
9418471230
drsukhdev@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC(Human)RGGPG Ayurvedic College Paprola |
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
|
| Type |
Name |
Details |
| Comparator Agent |
Ghritkumaryadi Aschyotan |
Ghritkumaryadi Aschyotan 1-2 drops 4-6 times a day for 4 weeks duration |
| Intervention |
Ghritkumaryadi Aschyotan with Glycerin |
Ghritkumaryadi Aschyotan with Glycerin 1-2 drops 4-6 times a day for 4 weeks duration |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to undergo trial.
Patients presenting with symptoms of shushkakshipaka w.s.r to Dry eye will be taken into account irrespective of sex,caste and religion.
Age group above 20 years. |
|
| ExclusionCriteria |
| Details |
Patients not willing to undergo trial.
Patients suffering from dry eye associated with other ocular disease (e.g.Squamous blepharitis,corneal ulcer,lagophthalmos,dacrocystitis,uveitis,any stage of glaucoma,allergic conjuctivitis) or systemic diseases |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in the signs and symptoms of dry eye syndrome |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate the effect of Ghritkumaryadi Aschyotan on dry eye syndrome |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
02/06/2021 |
| 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="1"
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 trial after completion of the trial as soon as possible. Patients will selected from OPD and IPD of RGGPG Ayurvedic College and Hospital Paprola. 2 groups of 20 patients will be registered then assessed to evalaute the effect of Ghritkumaryadi Aschyotan(drops) in Shushkakshipaka w.s.r to Dry Eye Syndrome |