A clinical study to evaluate the effect of a Unani Polyherbal formulation in the treatment of Diabetes Mellitus Type 2

A Randomised standard controlled clinical trial to evaluate the effect of a unani polyherbal formulation on ziabetus sukri qism doem (Diabetes Mellitus Type 2)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045501

Enrollment

Registered

2022-09-14

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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: Extract of Unani Polyherbal formulation {Kalonji (Nigella sativa), Darchini (Cinnamomum zeylanicum), Methi (Trigonella foenum graceum), Magz Tukhm-e-jamun (Syzygium cuminu), Zanjabeel (

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient with Fasting Blood sugar more than or equal to 126mg/dl, 2. Post prandial Blood sugar more than or equal to 200 mg/dl, 3. Random Blood sugar more than 200 mg/dl with clinical features of diabetes, 4. Patient with HbA1c more than or equal to 6.5, 5. Patient willing to participate in the study, sign the understood consent form and ready to follow the instructions

Exclusion criteria

Exclusion criteria: 1. Patient with a Fasting Blood sugar of more than 400 mg/dl, 2. Pregnant and lactating women, 3. Patient with Anaemia (Hb 4. Hepatic and Renal impairment, 5. Uncontrolled Infection (TB, UTI, etc.) 6. Malignancy or taking Chemotherapy, 7. Patient having Diabetes Insipidus, Diabetes Mellitus Type 1, Cushings syndrome and Acromegaly, 8. Patient taking any medication which raises the blood sugar level e.g; Steroids , Diuretics , Oral contraceptive pills etc.

Design outcomes

Primary

Measure	Time frame
1.Develop a safe, efficacious and cost-effective drug for Type 2 Diabetes Mellitus on scientific parameters. 2.Evaluate the hypoglycaemic control of Test drug for acheiving a safe range of blood sugar on HbA1c parameter. 3.Evaluate the efficacy of test drug in comparison to a standard hypoglycaemic agent.Timepoint: 1.Clinical examination and subjective evaluation would be done at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 13 weeks. 2.To evaluate efficacy- Blood sugar (F and PP) at the baseline, 1 Month, 2 Months, 3 Months. HbA1c at baseline and 3 months. 3.To Evaluate safety- Haemogram, LFT and KFT at the baseline, 8th day and after 13 weeks.	—

Measure

Time frame

1.Develop a safe, efficacious and cost-effective drug for Type 2 Diabetes Mellitus on scientific parameters. 2.Evaluate the hypoglycaemic control of Test drug for acheiving a safe range of blood sugar on HbA1c parameter. 3.Evaluate the efficacy of test drug in comparison to a standard hypoglycaemic agent.Timepoint: 1.Clinical examination and subjective evaluation would be done at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 13 weeks. 2.To evaluate efficacy- Blood sugar (F and PP) at the baseline, 1 Month, 2 Months, 3 Months. HbA1c at baseline and 3 months. 3.To Evaluate safety- Haemogram, LFT and KFT at the baseline, 8th day and after 13 weeks.

—

Secondary

Measure	Time frame
Evaluate the effect of Test drug on Insulin resistance.Timepoint: At the baseline, 1 month, 2 months and 3 months.	—

Countries

India

Contacts

Public ContactDr Khan Qasim Bilal

Ayurvedic and Unani Tibbia College Hospital

drrahman002@gmail.com9313980776

Outcome results

None listed

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