Clinical Study to Evaluate Qurs-e-Zayabitus Khas and Qurs-e-Tabasheer Over Metformin in Type-2 Diabetes Mellitus

Phase 2

Recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2019/04/018670
• Lead Sponsor: Central Research Institute of Unani Medicine Hyderabad

Brief Summary

Diabetes mellitus (***DhayÄbÄ«á¹­us ḤÄrr****)* 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 IshtihÄ(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 *DhayÄbÄ«á¹­us HÌ£Ärr Qism ThÄnÄ«* (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 *DhayÄbÄ«á¹­us HÌ£Ärr Qism ThÄnÄ«* (Type 2 Diabetes Mellitus)†has been designed.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-05
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Reduction in Fasting and PP plasma glucose (2-hPG) level	At baseline, 2wk, 4wk, 6wk, 8wk, 10wk, and 12wk
2.Decrease in HbA1c level by more than equal to 1 percent as compared to baseline	At baseline, 2wk, 4wk, 6wk, 8wk, 10wk, and 12wk
3.Improvement in the following symptoms of DhayÄbÄ«á¹­us HÌ£Ärr Qism ThÄnÄ« (Type 2 Diabetes Mellitus) on 0-100mm	At baseline, 2wk, 4wk, 6wk, 8wk, 10wk, and 12wk

Secondary Outcome Measures

Name	Time	Method
Hemogram, LFT, RFT, FPG, Urine R/M examination	At baseline and 8th followup

Trial Locations

Locations (1)

Central Research Institute of Unani Medicine- Hyderabad; 🇮🇳 Hyderabad, TELANGANA, India

Central Research Institute of Unani Medicine- Hyderabad

🇮🇳Hyderabad, TELANGANA, India

Anudeep Bathena

Principal investigator

9533298268

dranudeep.b@gmail.com