Safety and efficacy of Unani formulation in Diabetes Mellitus

Phase 2/3

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2025/03/082396
• Lead Sponsor: National Research Institute of Unani Medicine for Skin Disorders

Brief Summary

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|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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-06
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Inclusion Criteria: The following patients will be included in the study: 1.
• Patients of any sex aged thirty to sixty-five years.
• 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).
• Glycated Haemoglobin (HbA1c) between 6.5% and 8%.
• Patient willing to sign the written informed consent with / without.
• 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.

Exclusion Criteria

• The following patients will be excluded: 1.
• Patients aged less than 30 years or more than 65 years.
• 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.
• Pregnant or Lactating Women.
• Type 1 Diabetes Mellitus.
• Type 2 DM with complications.
• Obese Individuals – BMI greater than 35.
• Drug Addicts/ Alcoholics.
• Patient on any other treatment for diabetes.
• Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction.
• Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in Fasting Blood Glucose (FBG) level as compared to baseline	At baseline, 2, 4, 6, 8, 10 and 12 weeks
2. Change in Post-Prandial Blood Glucose (PPBG) level	At baseline, 2, 4, 6, 8, 10 and 12 weeks
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 Measures

Name	Time	Method
1. Improvement in symptoms on VAS Scale	At baseline, 2, 4, 6, 8, 10 and 12 weeks

Trial Locations

Locations (1)

National Research Institute of Unani Medicine for Skin Disorders; 🇮🇳 Hyderabad, TELANGANA, India

National Research Institute of Unani Medicine for Skin Disorders

🇮🇳Hyderabad, TELANGANA, India

DR SUHAIL KHAN

Principal investigator

09919197238

suhailishrak@gmail.com