| CTRI Number |
CTRI/2023/09/057645 [Registered on: 14/09/2023] Trial Registered Prospectively |
| Last Modified On: |
12/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of Unani drugs in the management of Prediabetes |
|
Scientific Title of Study
|
The Clinical Study of Prediabetes Patients and Comparative Evaluation of Unani Drugs in its Management |
| 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 Mohammad Afif Khan |
| Designation |
PG Scholar |
| Affiliation |
Aligarh Muslim University Aligarh |
| Address |
Department of Moalejat Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University Aligarh
Aligarh UTTAR PRADESH 202002 India |
| Phone |
8791910435 |
| Fax |
|
| Email |
mafifkhan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mursaleen Naseer |
| Designation |
Assistant Professor |
| Affiliation |
Department of Moalejat Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University Aligarh |
| Address |
Department of Moalejat Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University Aligarh
Aligarh UTTAR PRADESH 202002 India |
| Phone |
9412562724 |
| Fax |
|
| Email |
drmursaleen@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mohammad Afif Khan |
| Designation |
PG Scholar |
| Affiliation |
Aligarh Muslim University Aligarh |
| Address |
Department of Moalejat Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University Aligarh
Aligarh UTTAR PRADESH 202002 India |
| Phone |
8791910435 |
| Fax |
|
| Email |
mafifkhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Moalejat Ajmal Khan Tibbiya College Faculty of Unani Medicine Aligarh Muslim University Aligarh Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
Aligarh Muslim University |
| Address |
Department of Moalejat Ajmal Khan Tibbiya College and Hospital Aligarh |
| Type of Sponsor |
Government medical college |
|
|
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 Mohammad Afif Khan |
Ajmal Khan Tibbiya College Hospital |
Department of Moalejat Faculty of Unani Medicine Aligarh Muslim University Aligarh Aligarh UTTAR PRADESH |
08791910435
mafifkhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ajmal Khan Tibbiya College Faculty of Unani Medicine Aligarh Muslim University Aligarh India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R730||Abnormal glucose, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Barg-e-bael (Aegle marmalos)
|
5 grams powder of Barg-e-bael twice a day after meal orally for 3 months
|
| Intervention |
Tukhm-e-khurfa (Portulacum oleracea)
|
5 grams powder of Tukhm-e-khurfa twice a day after meal orally for 3 months
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient having fasting blood glucose range 100-125 mg/dl.
Patient having 2 hours oral glucose tolerance test level range 140-200 mg/dl.
Patient having HbA1C in range of 5.7- 6.4 %.
Patient willing to sign the written informed consent.
|
|
| ExclusionCriteria |
| Details |
Patient below 30 years and above 65 years.
Prediabetics suffering from any severe complications.
Patient with deranged kidney and liver profile.
Pregnant and lactating women.
Patient who fail to give consent.
Patient who fail to follow up.
Mentally retarded person.
Patient having uncontrolled hypertension.
Patient having any severe systemic illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Blood sugar fasting
HbA1C
|
0 days, 30 days, 60days, 90days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood sugar after 2 hrs oral glucose tolerance test |
0 days, 30 days, 60days, 90days |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
25/09/2023 |
| 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="1" Months="6" 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
|
Prediabetic is new nomenclature
created in 2002 by ADA & Dept of Health and Human Services. Prediabetes is
a practical & convenient term referring to IFG, IGT or glycated haemoglobin
(HbA1C) of 60% to 64% each of which places individual at high risk of
developing diabetes and its complications. The
World Health Organization (WHO) in 2006 has recommended the term Intermediate
Hyperglycemia to describe glycaemic levels between ‘normal’ glucose tolerance
and diabetes. The term ‘pre-diabetes’ is discouraged to avoid any stigma
associated with the word diabetes and the fact that many people do not progress
to diabetes as the term implies. This disease is also known as Zalaqal Kulliyah, Dolabiya,
Duvariya, Charaqia Moattasha, Silsil Al
Baul, Barkariyyah, Dawwar. According
to the Unani concept the virtual cause of Ziabetus is the fire like heat
in the kidneys where Rutubat in the form of water is absorbed in large
amounts and this cannot be filtered as the kidneys absorb water beyond their
capacity and they are not able to retain the volume as a result of which the
kidneys just get rid of the water by pushing it towards the bladder.The Quwate
Masika weakens because of the intense heat of the kidneys, the patient is
thirsty helplessly consuming water which is passed out through the kidney
immediately. It is similar to Zalqul Meda wal Ama, in which the food
passes swiftly through the stomach and intestine lacking proper digestion i.e Quwate
Dafi’ah is
strong. In this condition patient has excessive thirst and consumes plenty of
water and passes out all the water consumed without any Istehala (metabolism |