effect of Unani formulation in Diabetic patients

Effect of Unani formulation on Diabetes Mellitus in In-Vitro studies on HepG2 cell line along with In-vivo Pilot Clinical Study. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055902

Enrollment

150

Registered

2023-07-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

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: coded Unani Formulation UNIM 221: 5 grams orally twice daily for 6 weeks Control Intervention1: Metformin: 500 mg twice daily for 6 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Patients of any sex aged of 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 (or) HbA1c level between 6.5 and 8% (as per ADA 2010 Criteria) Presence of any of the following symptoms and signs of diabetes mellitus: Polydipsia, Polyuria, Nocturia, Giddiness, Fatigue, Loss of Weight, Polyphagia & Loss of Libido

Exclusion criteria

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/ Type 1 DM Significant pulmonary/ cardiovascular/ hepato-renal dysfunction Known cases of immune-compromised states (HIV/ AIDS, etc.)/ Malignancies Obese subjects (BMI >30) Pregnant and lactating women Drug addicts/ Alcoholics Patient not willing to attend treatment schedule regularly

Design outcomes

Primary

Measure	Time frame
The expected outcome of this study is that Unani formulation(s) might increase the expression of proposed genes & it would helps in inhibition of glycogen synthesis genes & in parallel it will help to uptake of glucose levels in blood. Unani drug(s) ingredients might alleviate glucose utilization, which may be mediated via elevating glucokinase activity and hepatic glycogen concentration. Timepoint: 3 years	—

Measure

Time frame

The expected outcome of this study is that Unani formulation(s) might increase the expression of proposed genes & it would helps in inhibition of glycogen synthesis genes & in parallel it will help to uptake of glucose levels in blood. Unani drug(s) ingredients might alleviate glucose utilization, which may be mediated via elevating glucokinase activity and hepatic glycogen concentration. Timepoint: 3 years

—

Secondary

Measure	Time frame
the results would act as bridge for performing on Human blood samples by applying the same Unani formulation(s) with Unani temperament.Timepoint: 3 years	—

Countries

India

Contacts

Public ContactTasleem Ahmad

National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD)

tasleem786@rediffmail.com9304109801

Outcome results

None listed

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