A study to compare efficacy and safety of coded Unani formulation UNIM D 2000 with Metformin in patients with Ziabetus Sukkari Qism-e-Sani (Diabetes Mellitus Type II)

A Single blind, randomized, parallel group study to compare efficacy and safety of coded Unani formulation UNIM D 2000 with Metformin in patients with Ziabetus Sukkari Qism-e-Sani (Diabetes Mellitus Type II)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/034986

Enrollment

Registered

2021-07-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: UNIM-D 2000 : UNIM-D 2000 (powder) 500mg Twice daily Orally with water Half hour before meals for 12 weeks Control Intervention1: Tablet Metformin: 850 mg twice daily to be taken orally

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of either gender in the age group of 18-65 years 2.HbA1c level >= 7% 3.Both newly diagnosed and known case of Type 2 DM may be included 4.Fasting plasma glucose levels between 126 and 200 mg/dl Or 5.2hr plasma glucose levels between 200 and 300 mg/dl And 6.Presence of any of the following symptoms and signs of diabetes mellitus: Utash mufrit (Polydipsia) Kasrat al-Bawl (Polyuria) Kasrat al-Ishtiha (Polyphagia) Bawl Layli (Nocturia) Iya (Fatigue) Naqs al-Wazn (Loss of Weight) Burning sensation in palm and soles Sadr (Giddiness) Naqs al-Shahwa (Loss of Libido) Duf al Hadm Bawl-e-raqueeque (lighter urine) with Kasrat al-Bawl Bawl-e-sufed (colourless urine) with Kasrat al-Bawl

Exclusion criteria

Exclusion criteria: 1.HbA1C >= 8% 2.Subjects with fasting plasma glucose level >200 mg/dl and /or PP plasma glucose level >300 mg/dl 3.Family history of Type 1 DM 4.Known cases of Metabolic syndrome 5.Diabetes Mellitus-Type 1 or subjects on Insulin therapy 6.Diabetes Mellitus associated with complications of Ketoacidosis 7.Patients on systemic corticosteroids/ disease modifying agents 8.Known cases of Ischemic Heart Disease/ Hyperlipidemia 9.Liver disorders SGPT >105 IU/L 10.Impaired renal function tests 11.Obese Subjects â?? BMI >35 12.Pregnant and lactating women 13.Known cases of Malignancy & Epilepsy 14.Known cases of any disorder requiring long-term treatment

Design outcomes

Primary

Measure	Time frame
Improvement in signs and symptoms of Ziabetus Sukkari Qism-e-Sani (Diabetes Mellitus Type II)Timepoint: 12weeks	—

Secondary

Measure	Time frame
Haematological and biochemical assessment for safety assessmentTimepoint: 12weeks	—

Countries

India

Contacts

Public ContactDr Pradeep Kumar

Central Council for Research in Unani Medicine

ccrum507@rediffmail.com9213511298

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026