| CTRI Number |
CTRI/2024/11/076780 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Ocular toxicity profile of hydroxychloroquine and its association with blood level of hydroxychloroquine. |
|
Scientific Title of Study
|
Ocular toxicity profile of hydroxychloroquine(HCQ) and its association with blood levels :A hospital based pilot study in north east India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Phulen Sarma |
| Designation |
Assistant Prof. |
| Affiliation |
AIIMS Guwahati pharmacology |
| Address |
Pharmacology, 2nd Floor, Medical College Building, AIIMS Guwahati, Kamrup, Assam
GUWAHATI
Kamrup
ASSAM
781101
India |
| Phone |
8728830834 |
| Fax |
|
| Email |
phulen10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajeesh Mohammed P Z |
| Designation |
Master of Pharmacy |
| Affiliation |
Department of Pharmacy Practice |
| Address |
NIPER Guwahati, Kamrup, Assam
NIPER Guwahati, Kamrup, Assam
Kamrup
ASSAM
781101
India |
| Phone |
9946785452 |
| Fax |
|
| Email |
ajeeshmohammed.p@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Phulen Sarma |
| Designation |
Assistant Prof. |
| Affiliation |
AIIMS Guwahati pharmacology |
| Address |
Pharmacology, 2nd Floor, Medical College Building, AIIMS Guwahati, Kamrup, Assam
GUWAHATI
ASSAM
781101
India |
| Phone |
8728830834 |
| Fax |
|
| Email |
phulen10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Investigator Dr. Phulen Sarma Assistant Professor of Pharmacology Department AIIMS Guwahati, self funded and NIPER Guwahati |
|
|
Primary Sponsor
|
| Name |
Phulen Sarma |
| Address |
AIIMS Guwahati, Kamrup District, Assam, India |
| 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 |
| Dr Phulen Sarma |
AIIMS Guwahati |
Ophthalmology/2nd floor/OPD Building
Kamrup
ASSAM |
8728830834
phulen10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Guwahati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M05-M14||Inflammatory polyarthropathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients suffering from
autoimmune disease attending
General medicine OPD and on
HCQ.
2. Patient on stable daily dose of
HCQ for at least 6 months
3. Have stable dose of
glucocorticoid/immunosuppressant
dose during the preceding 4
weeks.
4. Age of 18 to 60 yrs would be
included in the study.
5. Both sex Male and Female |
|
| ExclusionCriteria |
| Details |
1. Patients with pre-existing retinal
diseases
2. Media opacity obscuring retinal
evaluation.
3. Patient not cooperative for
visual field evaluation.
4. Pregnant and lactating woman.
5. eGFR lover than 60 ml/min,
chronic alcoholism and liver
failure. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find the ocular toxicity
profile of hydroxychloroquine
in patients attending
Rheumatology clinic on HCQ
therapy. |
Single time point while attending the OPD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find the association between
HCQ blood level & ocular
toxicity. |
Single time point at the time of attending OPD |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
27/11/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hydroxychloroquine is given to patients with arthropathy associated with autoimmune diseases. However, hydroxychloroquine use is associated with ocular toxicity. In this observational study, we want to study the ocular toxicity profile of hydroxychloroquine and relationship between HCQ blood levels with ocular toxicity profile. |