| CTRI Number |
CTRI/2021/02/031492 [Registered on: 23/02/2021] Trial Registered Prospectively |
| Last Modified On: |
08/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to see the effect of some Ayurvedic formulation in the form of topical application in the treatment of Shushkakshipaka with reference to dry eye |
|
Scientific Title of Study
|
Randomized controlled clinical trial of Draksha Siddha Ghrita Aschyotana and Carboxy
Methyl Cellulose 0.5% eye drops in the management of Shushkakshipaka.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Dhanashree Vitthal Gole |
| Designation |
M. S. Scholar Shalakyatantra (Ayurved) |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD No.09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune
Department of shalakya tantra, MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
8999248465 |
| Fax |
|
| Email |
gole.dhanashree1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilakshi Pradhan |
| Designation |
HOD and Professor of Shalakya tantra Department |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD No.09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune
MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Dhanashree Vitthal Gole |
| Designation |
M. S. Scholar Shalakyatantra (Ayurved) |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD No.09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune
Department of shalakya tantra, MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
8999248465 |
| Fax |
|
| Email |
gole.dhanashree1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra, Sane guruji Arogya Kendra, Malwadi road, Hadapsar,Pune |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune. |
| 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 |
| Vd Dhanashree Vitthal Gole |
Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune 411028 |
OPD No.09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune-411028
Pune
MAHARASHTRA |
8999248465
gole.dhanashree1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H048||Other disorders of lacrimal system. Ayurveda Condition: Shushkakshipaka, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Carboxy Methyl Cellulose 0.5% eye drop |
Carboxy Methyl Cellulose 0.5% eye drop is a combination of sodium chloride, Potassium chloride, Boric acid ,Magnesium chloride, 1 drop twice a day for 21 days |
| Intervention |
Draksha Siddha Ghrita |
It is a formulation of Ayurvedic herb prepared in the form of ghrita for topical application having combinatiomn of Draksha and Ghrita which will be administered in the form of Aschyotana one drop twicw a day for 21 days |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients suffering from symptoms of Shushkakshipaka.
2) Age -19-65yrs.
3) Irrespective of Either gender.
4) Only those cases will be accepted for final assessment that successfully complete the treatment in given time |
|
| ExclusionCriteria |
| Details |
1) Patients having complicated eye diseases or any severe occular infections like corneal ulcer etc.
2) Patients not ready for drug trial & follow up.
3) Patient having autoimmune disorders like RA, Sjogrens syndrome or any systemic diseases like Diabetic Mellitus, Hypertension. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A Clinical study to evaluate efficacy of Draksha Siddha Ghrita Aschyotana in Shushkakshipaka w.r.t Dry eye. parameter of efficacy is Schirmers test before and after treatment |
The drug will be given 21 days . the patient will be assessed before and after treatment . Total duration of study will be 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison between efficacy of Draksha Siddha Ghrita Aschyotana in Shushkakshipaka w.r.t. dry eye |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is open Labelled randomised comparative clinical trial to evaluate the effect of Draksha Siddha Ghrita Aschyotana twice a day for 21 days in comparison with Carboxy Methyl Cellulose 0.5% eye drops twice a day for 21 days in patients affected with shushkakshipaka w.r.t. Dry eye . The primary outcome will be effect of DrakshaSiddha Ghrita Aschyotana and the secondary outcome will be a comparison between trail drug and controlled drug in the management of Shushkakshipaka w.r.t. Dry eye |