| CTRI Number |
CTRI/2024/07/070625 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of curcumin in hearing loss and diabetes |
|
Scientific Title of Study
|
Effects Of Curcumin In Sensorineural Hearing Loss In Patients Having Type 2 Diabetes Mellitus Single Blind Randomized Control Trial |
| 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 Shanib Ali |
| Designation |
Post Graduate Student |
| Affiliation |
Jamia Hamdard University |
| Address |
ENT Department
HIMSR And HAHC Hospital
G772 M2X Block D
Hamdard Nagar
Guru Ravidas Marg
G772 M2X Block D
Hamdard Nagar
Guru Ravidas Marg
South
DELHI
110062
India |
| Phone |
9958926953 |
| Fax |
|
| Email |
shanib57ali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Monga |
| Designation |
Professor |
| Affiliation |
jamia hamdard |
| Address |
Professor
Department Of Pharmacology
HIMSR And HAHC Hospital
JAMIA HAMDARD
South
DELHI
110062
India |
| Phone |
8470040230 |
| Fax |
|
| Email |
dr.seema.monga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nusrat Nabi |
| Designation |
Associate Professor |
| Affiliation |
jamia hamdard |
| Address |
Associate Professor
Department Of Pharmacology
HIMSR And HAHC HOospital
JAMIA HAMDARD
South
DELHI
110062
India |
| Phone |
8953976858 |
| Fax |
|
| Email |
nusratnabinaikoo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Shanib Ali
Room no 2
ENT HNS
HIMSR And HAHC Hospital
Block D
Hamdard Nagar
New Delhi
110062
India |
|
|
Primary Sponsor
|
| Name |
Dr Shanib Ali |
| Address |
Room no 2
Dept Of ENT HNS
HIMSR And HAHC Hospital
Block D
Hamdard Nagar
New Delhi
110062
New Delhi |
| Type of Sponsor |
Other [] |
|
|
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 Seema Monga |
Hamdard Institute Of Medicine Sciences And Research |
G772+M2X,Block D
Room No 3 , 1st Floor Department Of Otorhinolaryngology
Hamdard Nagar ,Guru Ravidas Marg ,Hamdard Nagar ,New Delhi
South
DELHI |
08470040230
dr.seema.monga@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC -HIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CURCUMIN |
44 PATIENTS HAVING SNHL WITH TYPE 2 DIABETES MELLITUS WILL BE GIVEN 500MG CURCUMIN TDS FOR 8 WEEKS. ON DAY 0 AND AT 8 WEEKS PTA, CBC, LFT, KFT, LIPID PROFILE,HBA1C, MDA, SOD, HsCRP. |
| Comparator Agent |
Tablet Vitamin B12(Methylcobalamine) |
Tab Vitamin B 12 1500 micrograms (Methylcobalamine),once daily
orally for 8 Weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS WITH DIABETES MELLITUS TYPE 2
AGE 30-60
PATIENTS WITH DOCUMENTED SNHL. |
|
| ExclusionCriteria |
| Details |
patients on the insulin therapy
HBA1C more than 11%
H/O middle ear disease or surgery
h/o conductive hearing loss |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Magnitude of SNHL in type 2 DM
2.Evaluate potential of curcumin as therapeutic agent for treating of diabetes associated SNHL
3.Delineate risk factors associated with SNHL among type 2 DM population and serve as a cornerstone in formulating screening guidelinesfor SNHL in type 2 DM |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.changes in HBA1c
2 changes in lipid profile
3.changes in MDA ,SOD,HSCRP |
8weeks |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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 4 |
|
Date of First Enrollment (India)
|
24/07/2024 |
| 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
|
Randomized single blinded control trial recruiting 44 patients with type 2 DM having SNHL.Group A is the test group recieving 500mg tds curcumin for 8 weeksGroup B is control group recieving only standard treatment.Biochemical markers ,haematological investigations ,PTA done at zero day and 8 weeks to compare results
|