Clinical trial NCT06841497: Safety and Efficacy Assessment of Unani Formulation 'Dolabi' in Management of Diabetes Mellitus Type II
Official title: Safety and Efficacy Assessment of Unani Formulation 'Dolabi' in Management of Diabetes Mellitus Type II
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Type 2 DM
Keywords: Diabetes Mellitus
T2DM
Metabolic disease
Insulin Resistance
Lead sponsor: Hamdard University
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Diabetes is a chronic health condition that affects millions of people worldwide. In recent years, Pakistan has witnessed a significant increase in the prevalence of diabetes, making it a major public health concern. To address this growing problem, conducting clinical trials on diabetes in Pakistan is of utmost importance. Clinical trials play a crucial role in advancing medical knowledge, improving patient care, and finding effective treatments for diabetes.

This research aims to assess the safety and effectiveness of the Unani formulation Dolabi in treating type II diabetes mellitus. The study consists of two phases: a pre-clinical phase, which involves acute and subacute oral toxicity testing on animal models, and a clinical phase, which includes a single-blind, single-arm, multicenter, phase II clinical trial conducted at Shifa ul Mulk Memorial Hospital-Hamdard University and Haidery Herbal Care-North Nazimabad to evaluate its clinical efficacy.

Diabetes management plays a vital role in effectively controlling the disease and minimizing its complications. Lifestyle management plays significant role in managing blood glucose levels in all age and gender segments. Medications are prescribed to regulate blood glucose levels when lifestyle changes alone are insufficient. Regular monitoring of blood sugar levels, along with other important parameters like blood pressure and cholesterol, helps individuals with diabetes to track their progress and make necessary adjustments to their treatment plans.

Dolabi is a time tested formulation of HLWP and it is being used clinically for more than 05 years at Hamdard Matabs all around Pakistan and clinically found satisfactory. The current study is designed in accordance with ICH GCP E6 protocols as approved by WHO and DRAP. It will enable us to present this safer and locally produced combination for the large community suffering with this condition in improving their lives.


Eligibility criteria: Inclusion Criteria:

* Subjects having Type II Diabetes Mellitus.
* Subjects having raised FBS above 120 mg/dl and HbA1C level 6.7 or above.
* Subjects over 30 years of age.
* Subjects agree to use study medicine throughout the study.

Exclusion Criteria:

* Subjects suffering from chronic liver diseases and kidney failure.
* Subjects currently taking any hypoglycemic agent(s).
* Subjects suffering from any type of cancer and any other comorbid condition.
* Subjects having history of adverse drug reaction.
* Pregnant and Lactating mother.

Primary outcomes:
measure: Blood Sugars
timeFrame: 12 weeks
measure: HbA1C (Glycosylated Hemoglobin)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Shifa Ul Mulk Memorial Hospital-Hamdard University
state: Sindh
Study officials:
References: