Safety and Efficacy Assessment of Unani Formulation 'Dolabi' in Management of Diabetes Mellitus Type II

February 21, 2025 updated by: Abdul Bari, Hamdard University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74600
        • Shifa Ul Mulk Memorial Hospital-Hamdard University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Effect of Dolabi on DM II
Other: Dolabi
herbal remedy for DM II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Sugars
Time Frame: 12 weeks
Fasting Blood sugars at baseline and the end of treatment will be assess in (mg/dl).
12 weeks
HbA1C (Glycosylated Hemoglobin)
Time Frame: 12 weeks
Monitoring of HbA1C at baseline and at the end of treatment. the values of HbA1C will be assess in percentage (%).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamdard University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2024

Primary Completion (Estimated)

July 4, 2025

Study Completion (Estimated)

October 3, 2025

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DLB-PII-HLWP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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