| CTRI Number |
CTRI/2019/02/017680 [Registered on: 14/02/2019] Trial Registered Prospectively |
| Last Modified On: |
13/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of Manjishthadisiddha Ghrita Aschyotana and Darvisiddha Ghrita Aschyotana In Shushkakshipaka i.e dry eye disease |
|
Scientific Title of Study
|
Randomised controlled clinical trial to study the effect of Manjishthadisiddha Ghrita Aschyotana and Darvisiddha Ghrita Aschyotana In Shushkakshipaka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VdVarshali Madhukar Patil |
| Designation |
M.S Scolar Shalakyatantra |
| Affiliation |
Sumatibhai shah Ayurvedic college and hospital |
| Address |
OPD no.9 Department of Shalakyatantra,Sane Guruji Arogya Kendra,malwadi road, Hadapsar,Pune
Pune
MAHARASHTRA
411028
INDIA
Room no. 9
Shalakyatantra Department
Sane guruji arogya Kendra
Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
7020931420 |
| Fax |
|
| Email |
dr.varshalipatil16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSumedha J Pundge |
| Designation |
Guide |
| Affiliation |
Sumatibhai shah Ayurvedic college and hospital |
| Address |
OPD no.9 , Department of Shalakyatantra,Sane guruji arogya Kendra, malwadi, Hadapsar,
Pune
Room no. 9
Shalakyatantra Department
Sane guruji arogya Kendra
Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8275298480 |
| Fax |
|
| Email |
sumedhayk@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSumedha J Pundge |
| Designation |
Guide |
| Affiliation |
Sumatibhai shah Ayurvedic college and hospital |
| Address |
OPD no.9 , Department of Shalakyatantra,Sane guruji arogya Kendra, malwadi, Hadapsar,
Pune
Room no. 9
Shalakyatantra Department
Sane guruji arogya Kendra
Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8275298480 |
| Fax |
|
| Email |
sumedhayk@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra,Sane guruji arogya Kendra |
|
|
Primary Sponsor
|
| Name |
VdVarshali Patil |
| Address |
Sane guruji arogya Kendra Malwadi Hadapsar Pune |
| 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 |
| VdVarshali Madhukar Patil |
Sane Guruji Arogya Kendra, Hadapsar |
OPD no.9, Shalakyatantra Department, Sane Guruji Arogya Kendra, Malwadi,Hadapsar,
Pune-411028
Pune
MAHARASHTRA |
7020931420
dr.varshalipatil16@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: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Darvisiddha Ghrita Aschyotana |
Darvisiddha Ghrita Aschyotana 1 themb in each eye for 2 times per day as day 1st,7th,14th and 21st day. |
| Intervention |
Manjishthadisiddha Ghrita Aschyotana |
Manjishthadisiddha Ghrita Aschyotana 1 themb in each eye for 2 times of per days as day 1st ,7th ,14th n lastly 21st day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms like-
1. Netra shuskta.
2. Netra daha.
3. Netra paka. |
|
| ExclusionCriteria |
| Details |
Patients having symptoms like-
1.eye infection
2.autoimmune diseases
3. Systemic diseases |
|
|
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 Comparative clinical trial to study the effect of Manjishthadisiddha Ghrita Aschyotana and Darvisiddha Ghrita Aschyotana In shushkakshipaka |
A Comparative clinical trial to study the effect of Manjishthadisiddha Ghrita Aschyotana and Darvisiddha Ghrita Aschyotana In shushkakshipaka |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce the sign and symptoms of shushkakshipaka |
21 days..by interval of every 7 day |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/03/2019 |
| 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)?
|
|
Brief Summary
|
Randomised controlled clinical trial to study the effect of Manjishthadisiddha Ghrita Aschyotana and Darvisiddha Ghrita Aschyotana In Shushkakshipaka.A total 60patients will be selected for the study devided in two groups. The conclusion will be drawn according to the observation and result. |