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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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