| CTRI Number |
CTRI/2023/09/057695 [Registered on: 15/09/2023] Trial Registered Prospectively |
| Last Modified On: |
13/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Type 2 Diabetes with Unani formulation |
|
Scientific Title of Study
|
Gene Expression Analysis of the inflammatory markers in pathogenesis of Type-2 Diabetes to identify underlying Molecular mechanisms and Biomarkers and its relation to clinical phenotyping of Unani Philosophy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 029/17G/CCRUM/2022 – 2025 Version 02 dated 23-02-23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Syed Gulnawaz Ahmed |
| Designation |
Research Officer S4 |
| Affiliation |
National Research Institute of Unani Medicine for skin disorders |
| Address |
Room No 2, ROPD block, National Research Institute of Unani Medicine for Skin Disorders, AGs Colony Road, Erragadda
Hyderabad
TELANGANA
500038
India |
| Phone |
9848716693 |
| Fax |
|
| Email |
skgulnawaz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Gulnawaz Ahmed |
| Designation |
Research Officer S4 |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Room No 2, ROPD block, National Research Institute of Unani Medicine for Skin Disorders, AGs Colony Road, Erragadda
Hyderabad
TELANGANA
500038
India |
| Phone |
9848716693 |
| Fax |
|
| Email |
skgulnawaz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anwar Ahmed |
| Designation |
Head of the Institute |
| Affiliation |
National Research Institute of Unani Mediicne for Skin Disorders |
| Address |
Room No 2, ROPD Block, National Research Institute of Unani Mediicne for Skin Disorders, AGs Colony Road, Erragadda
Hyderabad
TELANGANA
500038
India |
| Phone |
9440417005 |
| Fax |
|
| Email |
dranwar_ahmed@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research In Unani Medicine New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
61-65 Institutional area, opp. D Block, Janakpuri, New Delhi |
| 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 |
| Dr Ahmed Minhajuddin |
National Research Institute of Unani Medicine for Skin Disorders |
Room no 2, ROPD Block, AGs Colony Road, Erragadda
Hyderabad
TELANGANA |
9177376011
ahmedminhajuddin@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Research Institute of Unani Medicine for Skin Disorders |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D758||Other specified diseases of bloodand blood-forming organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
COMPARED WITH HEALTHY VOLUNTEERS |
| Intervention |
Qurs-e-Ziabeties Khaas |
2 tablets twice daily to be given before meals up to 4 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The patients diagnosed with Type II diabetes, and having a Fasting Blood Sugar of 126 – 175mg/ 100ml and Post Prandial Blood Sugar of 200-250mg/100ml and HbA1C above 6.5 - 8 and Subjects without diabetes for controls. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria for patients and controls:-
The Subjects who are unwilling to give the blood sample.
Pregnant women, lactating women, cancer patients and mentally disorder people
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Blood sugar values |
0, 15, 30, 45,60, 75, 90, 105, 120 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| understanding of Type II diabetes progression & management in relation to Unani philosophy of medicine. |
4 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
29/09/2023 |
| 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)
|
Not Yet Recruiting |
| 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
|
Patients and controls fullfilling the inclusion and exclusion criteria will be recruited for the study. After
temperament assessment 5 ml of blood will be collected from each subject out of
whom 2ml will be taken in Paxgene tubes for conducting gene expression studies
and 3ml in plain tubes for conducting ELISA test. Clinical assessment will be carried out every 15 days during the treatment period.
Fasting and Post Prandial Blood Sugar will be measured every 15 days till the
final follow up.
HbA1C and safety profiles will be measured at the baseline and the final
follow-up (LFT, RFT, Hemogram & Urine Exam).
Qurs-e-Ziabeties Khaas is administered 2BD daily up to 4 months. The data thus collected is assessed after the completion of the study.
|