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CTRI Number  CTRI/2019/04/018670 [Registered on: 18/04/2019] Trial Registered Prospectively
Last Modified On: 16/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Study to Evaluate Qurs-e-Zayabitus Khas and Qurs-e-Tabasheer Over Metformin in Type-2 Diabetes Mellitus 
Scientific Title of Study   A Single Blind, Randomised, Active Controlled Clinical Study to Evaluate the Efficacy and Safety of a Combination of Unani Drugs – Qurs-e-Zayabitus Khas and Qurs-e-Tabasheer in DhayābÄ«á¹­us Ḥārr Qism ThānÄ« (Type 2 Diabetes Mellitus) 
Trial Acronym  PGAN 
Secondary IDs if Any  
Secondary ID  Identifier 
ZHQS/DM/QZK-QT-M/RCT/CCRUM/17-18 Version: 01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anudeep Bathena 
Designation  Research Scholar 
Affiliation  Central Research Institute Of Unani Medicine - hyderabad. 
Address  AG Colony Road, OPP. ESI Hospital, Erragadda, Hyderabad, 500038

Hyderabad
TELANGANA
500038
India 
Phone  9533298268  
Fax    
Email  dranudeep.b@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Qamar Uddin 
Designation  Professor 
Affiliation  Central Research Institute Of Unani Medicine, 
Address  AG-Colony Road, OPP. ESI Hospital, Erragadda, Hyderabad, 500038

Hyderabad
TELANGANA
500038
India 
Phone  8700027178  
Fax    
Email  ccrumhqrsnd58@gmail.com  
 
Details of Contact Person
Public Query  
Name  Tasleem Ahmed 
Designation  Research Officer 
Affiliation  Central Research Institute Of Unani Medicine,  
Address  Central Research Institute Of Unani Medicine, AG-Colony Road, OPP. ESI Hospital, Erragadda, Hyderabad, 500038

Hyderabad
TELANGANA
500038
India 
Phone  9304109801  
Fax    
Email  tasleem786@rediffmail.com  
 
Source of Monetary or Material Support  
Central Research Institute of Unani Medicine - AG Colony Road, opp. ESI hospital, Erragadda. Hyderabad, 500038. 
 
Primary Sponsor  
Name  Central Research Institute of Unani Medicine Hyderabad 
Address  Central Research Institute of Unani Medicine- Hyderabad. AG Colony Road, opp. ESI hospital, Erragadda. Hyderabad, 500038. 
Type of Sponsor  Research institution and hospital 
 
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 
Anudeep Bathena  Central Research Institute of Unani Medicine- Hyderabad  Room No-19, Ground floor, Old building, CRIUM, AG Colony Road, opp- ESI Hospital, Erragadda.
Hyderabad
TELANGANA 		 9533298268

dranudeep.b@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, CRIUM - Hyd  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A (Qurs-e-Zayabitus Khas and Qurs-e-Tabasheer)  Qurs-e-Zayabitus Khas and Qurs-e-Tabasheer will be prepared in a single batch, according to the standard method described in National Formulary of Unani Medicine (NFUM), at GMP certified Pharmacy of CRIUM, Hyderabad. Dose: Qurs-e-Zayabitus Khas Tablet Oral 1 gm BD To be taken with water before meals Qurs-e-Tabasheer Tablet Oral 1 gm BD To be taken with water before meals  
Comparator Agent  Group B (Metformin 500 mg)  Patients will be given Metformin (500 mg tablet) twice daily orally with water ½ hr before meals.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of any sex aged 30-65 years
Fasting plasma glucose levels between 126 and 175 mg/dL
or
Post Prandial plasma glucose levels between 200 and 250 mg/dL
(2 hours after ingestion of 75 gm of glucose in 300 ml of water)
or
HbA1c level between 6.5 and 8%
and
Presence of any of the following symptoms and signs of diabetes mellitus

(2 hours after ingestion of 75 gm of glucose in 300 ml of water)
or
HbA1c level between 6.5 and 8%
and
Presence of any symptoms and signs of diabetes mellitus
 
 
ExclusionCriteria 
Details  Subjects with FPG level >175 mg/dL and/ or PP plasma glucose level >250 mg/dL and/ or HbA1c >8%
Subjects on Insulin therapy
Type 2 DM with complications/ Secondary DM/Type 1 DM
Significant pulmonary/ cardiovascular/ hepato-renal dysfunction
Known cases of immunocompromised states (HIV/ AIDS, etc.)/ Malignancies
Obese subjects (BMI >30)
Pregnant and lactating women
Drug addicts/Alcoholics
Patient not willing to attend treatment schedule regularly
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Reduction in Fasting and PP plasma glucose (2-hPG) level
2.Decrease in HbA1c level by more than equal to 1 percent as compared to baseline
3.Improvement in the following symptoms of Dhayābīṭus Ḥārr Qism Thānī (Type 2 Diabetes Mellitus) on 0-100mm
 		 At baseline, 2wk, 4wk, 6wk, 8wk, 10wk, and 12wk 
 
Secondary Outcome  
Outcome  TimePoints 
Hemogram, LFT, RFT, FPG, Urine R/M examination  At baseline and 8th followup 
 
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)   01/05/2019 
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)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Diabetes mellitus (Dhayābīṭus Ḥārr) is a clinical syndrome characterized by chronic hyperglycaemia.(1) It is a leading cause of end stage renal disease, heart attacks, non-traumatic amputations, blindness with increasing the mortality and morbidity burden on the community. Chronic hyperglycaemia is responsible for diabetes’ microvascular complications affecting eyes (retinopathy), kidneys (nephropathy), and nerves (peripheral neuropathy).(1)

Globally, prevalence of Diabetes mellitus estimated by the IDF was around 382 million in 2013.(1,2) Approximately 5.1 million people aged between 20 and 79 years died from diabetes in 2013, accounting for 8.3% of global all-cause mortality among people in this age group.(3) It is estimated that by 2035, 592 million people worldwide will have diabetes, these equates to approximately 3 new cases every 10 seconds. The global health spending to treat diabetes and manage complications totaled at least USD 548 billion in 2013. By 2035, this number is projected to exceed USD 627 billion.(1,2)

Globally, several oral hypoglycaemic agents (OHA) are being used in the management of type 2 diabetes mellitus in conventional medicine. But, poor glycaemic control and prolonged usage contraindications of present oral hypoglycaemic agents (OHA), the entire world is concentrating towards the natural remedy cure.

In Unani classics, diabetes is classified as a clinical condition(4) characterized by Kathrat-i ‘Aá¹­ash (polydipsia), Kathrat-i Bawl (polyuria), Bawl LaylÄ« (Nocturia), Kathrat-i Ishtihā (Polyphagia), Naqs al-Wazn (Loss of Weight), I’ya  (Fatigue) and Sadr (Giddiness).(4,5,6)

Keeping in view the magnitude of the problem, and based on recent reports which suggest the efficacy and safety of various single as well as compound Unani formulations in the management of DhayābÄ«á¹­us Ḥārr Qism ThānÄ« (Type 2 Diabetes Mellitus)(15), a clinical study titled “A Single Blind, Randomised, Active Controlled Clinical Study to evaluate the Efficacy and Safety of a combination of Unani drugs – Qurs-e-Zayabitus Khas and Qurs-e-Tabasheer in DhayābÄ«á¹­us Ḥārr Qism ThānÄ« (Type 2 Diabetes Mellitus)” has been designed. 
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