| CTRI Number |
CTRI/2020/02/023619 [Registered on: 27/02/2020] Trial Registered Prospectively |
| Last Modified On: |
26/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study of Haridradi Parisheka and Moxifloxacin eye drop in anjananamika i. e stye |
|
Scientific Title of Study
|
Randomised comparative clinical trial to study the effect of Haridradi Parisheka and Moxifloxacin 0.5% eye drop in Anjannamika. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Darshan Chandrakant Dhage |
| Designation |
M.S. scholar Shalakyatantra (Ayurved Dhanvantari) |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya, Hadapsar, pune |
| Address |
OPD no. 9,Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra-411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9511296832 |
| Fax |
|
| Email |
dhagedarshan.18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrs Nilakshi Pradhan |
| Designation |
Head of Department, Shalakyatantra |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya, Hadapsar, pune |
| Address |
OPD no. 9,Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra-411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Darshan Chandrakant Dhage |
| Designation |
M.S. scholar Shalakyatantra (Ayurved Dhanvantari) |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya, Hadapsar, pune |
| Address |
OPD no. 9,Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra-411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9511296832 |
| Fax |
|
| Email |
dhagedarshan.18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra,Sane Guruji Arogya Kendra,Malwadi Road, Hadapsar, Pune |
|
|
Primary Sponsor
|
| Name |
SanGuruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune-411028 |
| 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 Darshan Chandrakant Dhage |
Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune |
OPD no. 9 ,Department of Shalakyatantra
,sane guruji arogya kendra, malwadi road, hadapsar, pune -411028
Pune
MAHARASHTRA |
9511296832
dhagedarshan.18@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: H000||Hordeolum (externum) (internum) ofeyelid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Haridradi Parisheka |
Parisheka(stream) of Haridradi decoction will be poured on affected eye for 5-10 min once a day |
| Comparator Agent |
Moxifloxacin 0.5% eye drop |
One drop thrice a day |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.patients having signs and symptoms of Anjannamika
2.patients irrespective of gender and religion.
3.patients of age group 19-50 years |
|
| ExclusionCriteria |
| Details |
1.patients having active systemic disease,auto immune disease acute respiratory distress or other febrile conditions etc
2. Patients having any corneal involvement,uveitis,conjunctivitis,any structural eye deformiity.
3.patient not willing for trial. |
|
|
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 efficasy of Haridradi Parisheka and Moxifloxacin 0.5% eye drop in Anjannamika i.e. Stye. |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cure of Anjannamika and reduced recurrence |
18 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
02/03/2020 |
| 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="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
|
This study is randomised comparative clinical trial to study the effect of Haridradi Parisheka and moxifloxacine 0.5% eye drop in Anjannamika. As there is need of easy Ayurvedic treatment to avoid reccurence of stye . |