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CTRI Number  CTRI/2017/12/010929 [Registered on: 20/12/2017] Trial Registered Prospectively
Last Modified On: 19/12/2017
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 for safety and effectiveness of Unani formulation in Diabetes Mellitus 
Scientific Title of Study   A Clinical Study to Evaluate the Efficacy and Safety of a Polyherbal Unani Formulation in the Management of Zayabitus Sukkari Qism Sani (Diabetes Mellitus Type 2) 
Trial Acronym  UNDM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NADEEM AHMAD 
Designation  PG SCHOLAR 
Affiliation  CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE HYDERABAD 
Address  DEPTT. OF MOALAJAT, CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE, OPP. ESI HOSPITAL, AG COLONY ROAD, ERRAGADDA, HYDERABAD, TELANGANA 500038

Hyderabad
ANDHRA PRADESH
500038
India 
Phone  9616173020  
Fax    
Email  drnadeemcrium85@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MOHAMMAD NAWAB 
Designation  READER 
Affiliation  CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE HYDERABAD 
Address  DEPTT. OF MOALAJAT, CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE, OPP. ESI HOSPITAL, AG COLONY ROAD, ERRAGADDA, HYDERABAD, TELANGANA 500038

Hyderabad
ANDHRA PRADESH
500038
India 
Phone  8100992044  
Fax    
Email  ccrumnawab@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Qamar Uddin 
Designation  Professor 
Affiliation  CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE HYDERABAD 
Address  DEPTT. OF MOALAJAT, CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE, OPP. ESI HOSPITAL, AG COLONY ROAD, ERRAGADDA, HYDERABAD, TELANGANA 500038

Hyderabad
ANDHRA PRADESH
500038
India 
Phone  8700027178  
Fax    
Email  ccrumhqrsnd58@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Unani Medicine, Ministry of AYUSH 
 
Primary Sponsor  
Name  CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE HYDERABAD 
Address  CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE, OPP. ESI HOSPITAL AG COLONY ROAD, ERRAGADDA, HYDERABAD, TELANGANA, 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 
Nadeem Ahmad  Central Research Institute of Unani Medicine  Room No. 6 (Ground Floor) Deptt. of Moalajat, CRIUM, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038
Hyderabad
ANDHRA PRADESH 
9616173020

drnadeemcrium85@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Biomedical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  TYPE II DIABETES MELLITUS,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Active Control Drug: Metformin (Tablet)  Patients will be given Metformin (Tablet) in the dose of one tablet (500 mg) twice daily orally with water ½ hr before meals.  
Intervention  Study Drug: A Polyherbal Unani Formulation (Powder)  Patients will be givenUnani Formulation (Powder) in the dose of 6g twice daily orally with water ½ hr before meals.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  i) Patients of any sex in the age group between18 and 65 years
ii) Fasting PlasmaGlucose levels between 126 and 150 mg/dL
or
PPPlasmaGlucoselevels between 200and 250 mg/dL
(2 hours after ingestion of 75 gm of glucose in 300 ml of water)
or
HbA1C level≥6.5 %(3) and
1. Presence of any of the following symptoms and signs of diabetes mellitus:
2. Utash Mufrit(Polydipsia)
3. Kasrat al-Bawl (Polyuria)
4. Kasrat al-Ishtiha (Polyphagia)
5. Bawl Layli (Nocturia)
6. I’ya(Fatigue)
7. Naqs al-Wazn (Loss of Weight)
8. Burning sensation in palm and soles
9. Sadr (Giddiness)
10. Naqs al-Shahwa (Loss of Libido)
 
 
ExclusionCriteria 
Details  1. Subjects with Fasting Plasma Glucose (FPG) level >150 mg/dl and /or PostprandialPlasma Glucose level >250 mg/dl
2. Diabetes Mellitus associated with complications of Ketoacidosis
3. Diabetes Mellitus Type-I/ Secondary Diabetes Mellitus/ 4.Patients on Insulin therapy
5. Significant Pulmonary/Cardiovascular/Hepato-renal dysfunction
6. Pregnant and lactating women
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of Response to Therapy
Clinical assessment will be done at 2, 4, 6, 8, 10, and 12 weeks and the response to treatment will be assessed using the following parameters:
1. Reduction in FPGand Postprandial Plasma Glucose (2-hPG) level
2. Decrease inHbA1c level by ≥1% as compared to baseline
Improvement in symptoms of ZayābīṭusSukkariQismSāni(Diabetes Mellitus Type 2) on Visual Analogue Scale (VAS) 
at baseline, 2wk 4wk 6wk 8wk 10wk and 12wk 
 
Secondary Outcome  
Outcome  TimePoints 
1. Assessment of Safety
2. Adverse Effects (AEs)
The adverse effects to therapy (either to test drug or control drug) will be recorded at each clinical assessment visit and also by investigations (done at week 0 and 12).
3. Haemogram: Hb%, TLC, DLC, ESR
4. LFTs: S. Bilirubin, SGOT, SGPT, S. Alkaline Phosphatase
5. KFTs: Serum Creatinine, Blood Urea Nitrogen (BUN)
6. Urine Examination: Routine & Microscopic
 
at baseline, 2wk 4wk 6wk 8wk 10wk and 12wk 
 
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)   01/02/2018 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Diabetes mellitus is a metabolic disorders of multiple etiology, characterized by hyperglycemia with disturbance of carbohydrates, fats, and protein metabolism resulting from defects in insulin secretion and insulin action. The cost of diabetes care is high and is escalating worldwide. It is estimated 673 billion USD spent due to diabetes (2). The number of people withdiabetes mellitus is increasing in every country, half of the people with diabetes mellitus do not know they have it. It is estimated by International Diabetes Federation (IDF) that193 million people with diabetes are undiagnosed and are therefore more at risk of developing complications. One in 15 adults is estimated to have glucose tolerance, and one in 7th birth is affected by gestational diabetes mellitus (GDM). Number of men was affected 215.2 million and women 199.5 million in 2015, half of the people who die from diabetes mellitus are under the age of 60 year. This disorder is frequently associated with long term complication such as atherosclerosis Ischemic Heart Disease (IHD) Chronic renal failure, diabetes ketoacidosis. Worldwide prevalence of diabetes was estimated to 415 million in 2015 but in India alone 69.1 million and in China 114 million people. On account of its complication, it is leading cause of morbidity and mortality. Due to these complications, diabetes mellitus has become global problem despite of advancement of modern science. Several anti-diabetics agents are already being used such as glibenclamide,gliclazide, glimepiride, metformin, etc. But these drugs are associated with certain side effects like purpura, disulfiram-like reaction, flu like symptoms, lactic acidosis, hepatic dysfunction.

     There are a number of classical compound formulations used for the management of Diabetes Mellitus in Unani system of medicine. To validate safety and efficacy of a polyherbal formulation comprising Gurmarbuti, Gilo Khushk and Maghz TukhmJamun, the present study entitled “A Clinical Study to Evaluate the Efficacy and Safety of a Polyherbal Unani Formulation in the Management of Zayabitus Sukkari Qism Sani (Diabetes Mellitus Type 2)”has been designed.

 
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