| CTRI Number |
CTRI/2021/06/034262 [Registered on: 16/06/2021] Trial Registered Prospectively |
| Last Modified On: |
25/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Study the effect of Dhatryadi Eye Drops in Cataract |
|
Scientific Title of Study
|
Randomized Controlled Clinical Study to Assess Effect Of Dhatryadi Eye Drops In Immature Senile Cataract |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anantrao Shankarrao Bangar |
| Designation |
Associate professor, Shalakyatantra dept |
| Affiliation |
yashwant Ayurved college Kodoli |
| Address |
Shalakyatantra department S C M Aryangla Vaidyak Mahavidyalaya ITI Road Gendamal Satara
Kolhapur
MAHARASHTRA
415002
India |
| Phone |
9822620859 |
| Fax |
|
| Email |
drasbangar1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekhar Namdevrao Mule |
| Designation |
Professor & HOD |
| Affiliation |
Yashwant Ayurved Mahavidyalaya kodoli |
| Address |
Shaiakyatantra department Yashwant Ayurved Mahavidyalaya Kodoli Tal. Panhala Dist. Kolhapur Maharashtra India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9175800710 |
| Fax |
|
| Email |
drcnm05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anantrao Shankarrao Bangar |
| Designation |
Associate Professor |
| Affiliation |
Yashwant Ayurved Mahavidyalaya kodoli |
| Address |
Shalakyatantra dept S C M Aryangla Vaidyak Mahavidyalaya ITI Road Gendamal Satara
Satara
MAHARASHTRA
415002
India |
| Phone |
9822620859 |
| Fax |
|
| Email |
drasbangar1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dhatryadi Eye Drops, Daily OPD Patients Of Shalakya dept Yashwant ayurved college Kodoli, SCM Aryangla Vaidyak Mahavidyalaya Satara |
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Private medical college |
|
|
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 Anantrao Shankarrao Bangar |
Yashwant Ayurved college |
Kodoli Dist Kolhapur
Kolhapur
MAHARASHTRA |
9822620859
drasbangar1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee YAC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Catagon eye drops |
Nacl kcl 2 drops bid duration one month |
| Intervention |
Dhatryadi eye drops |
Dhatri saindhav pippali marich Honey 2 drops bid, duration one month |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sign and symptoms of immature senile cataract. |
|
| ExclusionCriteria |
| Details |
KNOWN CASE OF DIABETES PATIENTS WITH EXTRAOCULAR OR INTRAOCUIAR DISEASES |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO evaluate effect of Dhatryadi eye drops in immature senile cataract |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate effect of Dhatryadi eye drops in immature senile cataract
To study the adverse effect of dhatryadi eye drops
To find out cost effectiveness of treatment
To study beneficial effect of ancient mode of treatment in modern era |
1st 7th 15th 30th day for trial medication & observations
Total study Duration is of 2 years |
| whether dhatryadi rasakriya eye drop will remain sterile after 30 days |
To evaluate sterility of preservative free dhatryadi eye drops after 30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
16/06/2021 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - drasbangar1@gmail.com
- For how long will this data be available start date provided 15-07-2021 and end date provided 30-01-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Dhatryadi eye drops contains DHATRI SAINDHAV PIPPALI MARICH AND HONEY. Approval letter is taken from ethics commitee for synapsis title and overall study. In review there is need to develop herbal medicinal remedy for immature cataract. |