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CTRI Number  CTRI/2019/08/020838 [Registered on: 22/08/2019] Trial Registered Prospectively
Last Modified On: 06/09/2020
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 safety and efficacy of Unani formulation Safoof-e-Ziabetus Dulabi in Type 2 Diabetes Mellitus  
Scientific Title of Study   “A Randomized Standard Controlled Clinical Study to Compare the Safety and Efficacy of a Unani Formulation Safoof-e-Ziabetus Dulabi with Metformin in Dhayābīṭus Hārr Qism ThānÄ« (Type 2 Diabetes Mellitus)” 
Trial Acronym  T2DM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ghousia Tabassum 
Designation  Ph.D Scholar  
Affiliation  Jamia Millia Islamia , New Delhi 
Address  PG Dept. of Moalajat, Govt. Nizamia Tibbi College, Charminar, Hyderabad.

Hyderabad
TELANGANA
500002
India 
Phone  8639467243  
Fax    
Email  ghousia_tabassum@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr M A Faroqui 
Designation  Professor 
Affiliation  Govt. Nizamia Tibbi College 
Address  PG Dept. of Moalajat, Govt. Nizamia Tibbi College, Charminar, Hyderabad.

Hyderabad
TELANGANA
500002
India 
Phone  8309160124  
Fax    
Email  drfaroqui@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr M A Faroqui 
Designation  Professor 
Affiliation  Govt. Nizamia Tibbi College 
Address  PG Dept. of Moalajat, Govt. Nizamia Tibbi College, Charminar, Hyderabad.

Hyderabad
TELANGANA
500002
India 
Phone  8309160124  
Fax    
Email  drfaroqui@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Unani Medicine  
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine  
Address  61-65, Institutional Area, Opp. D-Block, Janakpuri, New Delhi, Delhi 110058  
Type of Sponsor  Government funding agency 
 
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 Ghousia Tabassum  Govt. Nizamia Tibbi College & General Hospital  OPD Room No:2, Moalajat, OPD Block, near Charminar, Hyderabad 500002.
Hyderabad
TELANGANA 
8639467243

ghousia_tabassum@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee  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 
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. For a duration of 12 weeks  
Intervention  Study Drug: Safoof-e-Ziabetus Dulabi  Patients will be given Safoof-e-Ziabetus Dulabi (Powder) in the dose of 6g twice daily orally with water ½ hr before meals. For a duration of 12 weeks. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  i) Patients of any sex in the age group between 25 and 60 years
ii) Fasting Plasma Glucose levels between 126 and 175 mg/dL
or
Post pandrial Plasma Glucose levels between 200 and 250 mg/dL
(2 hours after ingestion of 75 gm of glucose in 300 ml of water)
or
iii)HbA1C level≥6.5 % and
iv) 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. Sozish-e-Kaf-e-Dast-o-Pa (Burning sensation in palm and soles)
9. Sadr (Giddiness)
10. Naqs al-Shahwa (Loss of Libido 
 
ExclusionCriteria 
Details  Any of the following:
1. Subjects with fasting plasma glucose level >175 mg/dl and /or
2. Post-pandrial plasma glucose level >250 mg/dl
3. Subjects on Insulin therapy
4. Diabetes Mellitus-Type I
5. Secondary Diabetes Mellitus
6. Diabetes Mellitus associated with complications of Ketoacidosis.
7. Ischemic Heart Disease/ Hypertension/ Hyperlipidemia
8. Liver disorders
9. Impaired Renal function tests
10. Obese Subjects – BMI >30
11. Pregnant and lactating women
12. Any infective disorder requiring long-term treatment
13. Drug addicts/ Alcoholics
14. Malignancy/ Epilepsy
 
 
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 FPG and Postprandial Plasma Glucose (2-h PG) level
2. Decrease inHbA1c level by ≥1% as compared to baseline
Improvement in symptoms of Dhayābīṭus Ḥārr Qism Thānī (Type 2 Diabetes mellitus) on Visual Analogue Scale (VAS)
 
At baseline, 2wk, 4wk, 6wk, 8wk, 10wk and 12wk.  
 
Secondary Outcome  
Outcome  TimePoints 
Haematological and biochemical assessments for safety.
i)Serious Adverse Event (SAE)
ii)Adverse Event / Adverse Drug Reaction (AE/ADR)
iii)Laboratory Abnormalities as AEs
Haemogram, Liver Function Test(LFT), Kidney Function Test(KFT), Lipid profile, Thyroid profile, Complete Urine Examination (CUE): Routine & Microscopic, Erythrocyte Sedimentation Rate(ESR), Electrocardiogram(ECG)
 
The adverse effects to therapy (either to test drug or control drug) will be recorded at each clinical assessment visit i.e At baseline, 2wk, 4wk, 6wk, 8wk, 10wk and 12wk and also by investigations (done at week 0 and 12).
 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   26/08/2019 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 (Dhayābīṭus Ḥārr) refers to a group of common metabolic disorders that share the phenotype of hyperglycemia. Several distinct types of DM exist and are caused by a complex interaction of genetics and environmental factors. Depending on the etiology of the DM, factors contributing to hyperglycemia include reduced insulin secretion, decreased glucose utilization, and increased glucose production. The metabolic dysregulation associated with DM causes secondary pathophysiologic changes in multiple organ systems that impose a tremendous burden on the individual with diabetes and on the health care system. Diabetes is one of the most challenging health problems of the 21st century. Type 2 DM is a significant cause of premature mortality and morbidity related to cardiovascular disease, macrovascular complications, and microvascular complications in older adults. The prevalence of diabetes is rapidly rising all over the globe at an alarming rate. 

Globally, prevalence of Diabetes mellitus estimated by the IDF was estimated to 425.0 million (8.8% of adult 20-79 years) in 2017; by 2045 this will rise to 629 million. The proportion of people with type 2 diabetes is increasing in most countries. India alone has 72.9 million and in China 114.4 million. 1 in 2 (212 million) people with diabetes were undiagnosed. About 79% of people with diabetes live in low and middle income countries. The diabetes-related health expenditure will exceed from USD 727 billion (2017) to USD 776 billion (2045). In spite of a good number of drugs developed by the modern system of medicine there are many clinical issues which are still to be addressed like the effective control on the function of pancreas in diabetes mellitus, insulin resistance and diabetes related complications. These drugs are known to maintain the blood glucose at the required normal level and do not prevent the complications of T2DM. Further the use of these modern drugs is associated with various adverse effects. Unani system of medicine claims to possess a number of cost effective and safe compound and single drugs that can be used in management of Diabetes mellitus.  

In Unani medicine, diabetes has been mentioned with different names like ’Dhayābīṭus’, ’DÅ«lābiyya’ (water wheel), ’Diasquemus’, ’Qaramis’, ’Zalq al-Majari’, ’Salas al-Bawl’, ’Zalq al-Kulya’, Dawwāriyya (symptoms repeated in cyclic order), Mu‘aá¹­á¹­isha (thirst producing), Atsha, Intesae Anmas, parkar, parkāriyya, ,etc. Dhayābīṭus Ḥārr is mentioned in most of the Unani classical literature like Al-Qanun, Kamil al-Sanaa, Al-Hawi, etc. 

After the review of Unani literature as well as recent analytical data, a compound unani formulation known as Safoof-e-Ziabetus Dulabi is selected for the study.  Sufoof - e - Ziabetes - Dulabi (SZD) is a polyherbal Unani preparation widely prescribed for Dhayābīṭus Sadiq (Diabetes mellitus) and á¸Œâ€˜uf-i-kulya (weakness of the kidney).The present study entitled â€œA Randomized Standard Controlled Clinical Study to Compare the Safety and Efficacy of a Unani Formulation Safoof-e-Ziabetus Dulabi with Metformin in Dhayābīṭus Hārr Qism ThānÄ« (Type 2 Diabetes Mellitus)”  is designed to clinically evaluate the safety and efficacy of a unani formulation SZD as compared to metformin in patients with Dhayābīṭus Ḥārr Qism ThānÄ« (Type 2 Diabetes Mellitus) the present study is taken for the first time and considers the assessment of the scientific validity of an age old, time tested Unani Pharmacopoeial formulation in Dhayābīṭus Ḥārr Qism ThānÄ«.
This study is designed as a unicentric, randomized, open label,  standard controlled clinical trial in patients with Dhayābīṭus Ḥārr Qism ThānÄ« (Type 2 Diabetes Mellitus).

Composition of Safoof-e-Ziabetus Dulabi 

 Post-e-Andrun-e-Darakht-e-Guler                           20gm

Gil-e-Armani                                                              10gm

Gulnar Farsi                                                              10gm

Dana Anar Shireen                                                    10gm

Maghz-e-Tukhm-e-Anba                                           10gm

Amla                                                                           10gm

Kishneez Khushk                                                       10gm

 
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