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CTRI Number  CTRI/2025/03/082396 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 13/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Safety and efficacy of Unani formulation in Diabetes Mellitus 
Scientific Title of Study   A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Compare the Safety and Efficacy of Safuf-i-Dhayabitus (a Unani Formulation) With Metformin in the Management of Dhayabitus Harr Qism Thani (Type 2 Diabetes Mellitus )  
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 SUHAIL KHAN 
Designation  PG Scholar(Unani) 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department of Moalajat (Medicine) National Research Institute of Unani Medicine for Skin Disorders 8-3-168/A/1/UM, A.G. Colony Road, ESI Metro Station, Erragadda Hyderabad TELANGANA
Department of Moalajat (Medicine) National Research Institute of Unani Medicine for Skin Disorders 8-3-168/A/1/UM, A.G. Colony Road, ESI Metro Station, Erragadda Hyderabad TELANGANA
Hyderabad
TELANGANA
500038
India 
Phone  9919197238  
Fax    
Email  suhailishrak@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Mohammad Nasar 
Designation  Professor & HOD 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department of Moalajat (Medicine) National Research Institute of Unani Medicine for Skin Disorders 8-3-168/A/1/UM, A.G. Colony Road, ESI Metro Station, Erragadda Hyderabad TELANGANA
Department of Moalajat (Medicine) National Research Institute of Unani Medicine for Skin Disorders 8-3-168/A/1/UM, A.G. Colony Road, ESI Metro Station, Erragadda Hyderabad TELANGANA
Hyderabad
TELANGANA
500038
India 
Phone  8328446962  
Fax    
Email  drnasar.nriumsd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Mohammad Nasar 
Designation  Professor & HOD 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department of Moalajat (Medicine) National Research Institute of Unani Medicine for Skin Disorders 8-3-168/A/1/UM, A.G. Colony Road, ESI Metro Station, Erragadda Hyderabad TELANGANA
Department of Moalajat (Medicine) National Research Institute of Unani Medicine for Skin Disorders 8-3-168/A/1/UM, A.G. Colony Road, ESI Metro Station, Erragadda Hyderabad TELANGANA
Hyderabad
TELANGANA
500038
India 
Phone  8328446962  
Fax    
Email  drnasar.nriumsd@gmail.com  
 
Source of Monetary or Material Support  
Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders (Formerly Central Research Institute of Unani Medicine) Hyderabad. 
 
Primary Sponsor  
Name  National Research Institute of Unani Medicine for Skin Disorders 
Address  National Research Institute of Unani Medicine for Skin Disorders,A.G.’s 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 
DR SUHAIL KHAN  National Research Institute of Unani Medicine for Skin Disorders  OPD & IPD of Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders (Formerly Central Research Institute of Unani Medicine), 8-3- 168/A/1/UM, A.G. Colony Road, ESI Metro Station, Erragadda, Hyderabad - 500038 Hyderabad TELANGANA
Hyderabad
TELANGANA 		 09919197238

suhailishrak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, NRIUMSD, Hyderabad  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  Metformin 500 mg  1. Tablet Metformin: Dosage Form: Tablets (Solid) Dose: 500mg BD Mode of Administration: Oral  
Intervention  Safuf-i-Dhayabitus (Oral)  1. Safuf-i-Dhayabitus : Dosage Form: Safuf(Powder) Dose: 3gm BD Mode of Administration: Oral Composition: 1. Gurmar Boooti(Gymnema sylvestre Retz.) 2. Jamun(Syzygium cumini L.) 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Inclusion Criteria: The following patients will be included in the study:
1. Patients of any sex aged thirty to sixty-five years.
2. Fasting Blood Glucose (FBG) Levels between 126 and 150 mg/dL (after 8-12 hours of fasting) or
3. Post-Prandial Blood Glucose (PPBG) Level between 200 and 250 mg/dL (after 2 hours of ingestion of meal).
4. Glycated Haemoglobin (HbA1c) between 6.5% and 8%.
5. Patient willing to sign the written informed consent with / without.
6. Presence of any of the following classical symptoms of Dhayabitus Harr Qism Thani (Type 2 Diabetes Mellitus):
7. Utash Mufrit (Polydipsia)
8. Kasrat al-Bawl (Polyuria)
9. Kasrat al-Ishtiha (Polyphagia)
10. Bawl Layli (Nocturia)
11. Burning sensation in palms and soles
12. Naqs al-Wazn (Weight Loss)
13. Iya (Fatigue)
14. Zoaf-i-Am (General Weakness)
15. Giddiness 
 
ExclusionCriteria 
Details  The following patients will be excluded:
1. Patients aged less than 30 years or more than 65 years.
2. Participants with fasting plasma glucose level more than 150 mg/dL and /or PP plasma glucose level more than 250 mg/dL and/ or HbA1c greater than 8 percent.
3. Pregnant or Lactating Women.
4. Type 1 Diabetes Mellitus.
5. Type 2 DM with complications.
6. Obese Individuals – BMI greater than 35.
7. Drug Addicts/ Alcoholics.
8. Any disorder requiring long-term treatment.
9. Patient on any other treatment for diabetes.
10. Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction.
11. Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies.
12. Patient not willing to attend treatment schedule regularly. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Change in Fasting Blood Glucose (FBG) level as compared to baseline
2. Change in Post-Prandial Blood Glucose (PPBG) level
3. Decrease in HbA1C level by greater than or equal to 1% as compared to baseline
 		 At baseline, 2, 4, 6, 8, 10 and 12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Improvement in symptoms on VAS Scale   At baseline, 2, 4, 6, 8, 10 and 12 weeks 
 
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/ Phase 3 
Date of First Enrollment (India)   02/06/2025 
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 Yet Recruiting 
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  

Diabetes mellitus is defined as a heterogeneous metabolic disorder characterized by common feature of chronic hyperglycemia with disturbance of carbohydrate, fat and protein metabolism. Diabetes Mellitus is a leading cause of morbidity and mortality world over. It is expected to continue as a major health problem owing to its serious complications, especially end stage renal disease, IHD, gangrene of the lower extremities, and blindness in the adults. The rise in prevalence is more for Type 2 DM than Type 1 DM.  Diabetes is a major health issue that has reached alarming levels. Today, more than half a billion people are living with diabetes worldwide. According to IDF Atlas in 2023, on diabetes and kidney disease –

1.       Prevalence and Incidence:

·       About 30-40% of people with diabetes develop chronic kidney disease (CKD), with type 2 diabetes being the main contributor.

·       The number of new cases of CKD due to type 2 diabetes increased globally from 1.4 million in 1990 to 2.4 million in 2017, marking a 74% increase.

·       The age-standardized incidence of diabetes-related CKD was 29.15% per 100,000 in 2017.

2.       Risk and Demographics:

·       People with diabetes-related kidney disease face a higher risk of cardiovascular disease (CVD), progression to kidney failure, and death.

·       The prevalence of CKD is higher among the elderly and varies significantly based on the country’s healthcare infrastructure and socio-economic conditions.

3.       End-Stage Kidney Disease (ESKD):

·       Diabetes is a leading cause of kidney failure or ESKD, where treatment like dialysis or kidney transplantation is required.

·       Access to renal replacement therapy ranges from 27% to 53% globally, with availability lower in low- and middle-income countries.

·       The global prevalence of diabetes in individuals with ESKD increased from 19% in 2000 to 29.7% in 2015..2





Despite of advances in the treatment of Diabetes Mellitus it becomes the major epidemic among NCDs. Treatment for diabetes mellitus includes insulin therapy and oral antidiabetic drugs. Oral anti diabetic drugs include Sulphonylurease such as Glimepiride, Gliclazides, Thiazolidinediones and Biguanides but it has certain adverse effects such as abdominal discomfort, nausea, vomiting, diarrhea, weight gain. Therefore search of safe and effective drug for Diabetes Mellitus is the thrust area for research in medical fields. Unani system of medicine (USM) offers treatment for Diabetes Mellitus type 2. Many classical prescriptions comprising single herbo-mineral drugs and pharmacopoeial formulations have been recommended for the management of diabetes mellitus type 2 which are safe and cost effective. Such as Qurs-eTabasheer, Qurs-e- kafoor, Qurs-e-Dhayabitus, Safuf Dhayabitus, Qurs-egulnar, Kushta Baidha Murgh. Some of these drugs mentioned in classic literature have not been explored scientifically regarding their safety and efficacy. Safuf-i-Dhayabitus  (a Unani Formulation) has been selected after thorough literature survey expecting a promising result. The aim of this study is to record and document the efficacy and safety of the Unani formulation in the management of diabetes mellitus Type 2 which may become a piece of evidence that would validate the indication of the Unani formulation in the management of diabetes mellitus Type 2. Therefore present clinical trial entitled as A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of Safuf-i-Dhayabitus  (a Unani Formulation) With Metformin in the Management of Dhayabitus Harr Qism Thani (Type 2 Diabetes Mellitus) ) has been planned, to evaluate its safety and therapeutic efficacy on scientific parameter.
 
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