| CTRI Number |
CTRI/2017/06/008747 [Registered on: 05/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
09/06/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Education and Treatment adjustment] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check the effect of counselling and treatment adjustment of diabetic patients observing Ramadan fast. |
|
Scientific Title of Study
|
Effect of Education and intervention and Diabetic Control During Observation of Ramadan Fast: Prospective study in population in New Delhi |
| Trial Acronym |
RADEMI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Sunil Kohli |
| Designation |
Head, Department of General Medicine |
| Affiliation |
Hamdard Institute of Medical Science and Research, Jamia Hamdard |
| Address |
Room no. G-12, Ground floor, Department of Medicine, Hamdard Institute of Medical Science and Research, Jamia Hamdard , Hamdard Nagar , New Delhi, India
New Delhi
DELHI
110062
India |
| Phone |
9873351206 |
| Fax |
|
| Email |
sunil.kohli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sunil Kohli |
| Designation |
Head, Department of General Medicine |
| Affiliation |
Hamdard Institute of Medical Science and Research, Jamia Hamdard |
| Address |
Room no. G-12, ground floor,Department of Medicine, Hamdard Institute of Medical Science and Research, Jamia Hamdard , Hamdard Nagar , New Delhi, India
New Delhi
DELHI
110062
India |
| Phone |
9873351206 |
| Fax |
|
| Email |
sunil.kohli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilanjan Saha |
| Designation |
Head, Department of Pharmacology |
| Affiliation |
Hamdard Institute of Medical Science and Research,Jamia Hamdard |
| Address |
Room no. 240, 2nd floor, Department of Pharmacology, Hamdard Institute of Medical Science and Research, Jamia Hamdard , Hamdard Nagar , New Delhi, India
New Delhi
DELHI
110062
India |
| Phone |
9873013366 |
| Fax |
|
| Email |
nilanjan.saha@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| Hamdard Institute of Medical Science and Research, Alaknanda Badarpur Road, Near Senetary Hospital, Tughlakabad Extension, Hamdard Nagar, Delhi 110062 |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Jamia Hamdard , Hamdard Nagar , New Delhi, India, 110062 |
| 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 |
| Prof Dr Sunil Kohli |
Hakeem Abdul Hameed Centenary Hospital |
Room no. 27, Department of General Medicine, Hakeem Abdul Hameed Centenary Hospital, Guru Ravidas Marg, Hamdard Nagar, Delhi 110062
New Delhi
DELHI |
9873351206
sunil.kohli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Education and Treatment adjustment Intervention |
Recruited patients will be provided with treatment alterations by Health Care Practitioner and Ramadan focused education through counselling and handouts with the help of a dietician and Research Scholar. Since this is a basic education and dietary intervention, no dose, duration of drug can be given. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients Practicing Islam
2. Patients suffering from diabetes (FBS- equal to or more than 126mg/dl) for at least one year.
3. Patients who provide written and signed informed consent prior to initiation of treatment |
|
| ExclusionCriteria |
| Details |
1. Patients who do not practice Islam
2. Newly Diagnosed Diabetic Patients
3. Those patients who do not fast in Ramadan
4. Mentally challenged and unconscious
patients.
5. Those not willing for consent will be
excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight Control |
After 2 weeks of Ramdan |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of patients facing hypoglycemic and hyperglycemic events. |
After 2 weeks of Ramadan |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/05/2017 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an educational and treatment adjustment interventional study. The Patient pool will comprise of those diabetic patients who would be reporting to the OPD of HAH Centenary hospital, diagnosed by the clinical investigator, depending on the inclusion and exclusion criteria. The anti-diabetic drugs will be adjusted according to guidelines of International Diabetic Federation In collaboration with Diabetes and Ramadan International Alliance. Data regarding medical conditions and treatment will be collected in the Performa. The dose will be adjusted by the clinical investigator and counseling to the patients regarding diet and when to break the fast will be provided verbally. A printed handout will also be provided to the patients. Patients will be followed to check the effect of adjusted drugs and occurrence of hypoglycemic and hyperglycemic symptoms. The hypoglycemic and hyperglycemic symptoms will be recorded in follow up form and doses will be again adjusted if symptoms are observed. Weight of patients and occurrence of hypoglycemic/Hyperglycemic events will be recorded after of Ramadan. |